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The Global Market for Medical Devices, 11th Edition
Publication Date: April 21, 2021
Tags: Cardiovascular Disease, Diagnostic Instruments, Imaging Instruments, In Vitro Diagnostics (IVD), Lab Equipment, Lab Instruments, Medical Devices, Respiratory Diseases
Pages: 295
SKU: 21-020
The medical device industry faces unique challenges and opportunities, especially highlighted during the events of 2020. This heavily regulated industry must navigate approval and reimbursement processes, often influenced by group purchasing organizations and government negotiations. Companies are driven to invest continuously in research and development to innovate and succeed. Despite these challenges, the industry benefits from serving a growing elderly population worldwide and remains a priority for emerging markets with increasing economies and healthcare spending.
Report Highlights:
- Impact of COVID-19: This eleventh edition of Kalorama Information’s The Global Market for Medical Devices explores new market trends and forecasts influenced by the COVID-19 pandemic. The pandemic has shifted market share positions for some companies, with mergers, restructuring, and divestitures impacting results. While market growth continues, the volume of acquisitions declined in 2020 due to uncertain conditions.
- Trends Affecting the Market: The US economy is recovering from 2020 setbacks, while Europe experienced a slowdown due to Q4 lockdowns. Both regions face reimbursement challenges and potential legislative changes. Emerging markets contributed to revenue growth, but double-digit growth rates of previous years were absent in 2020, leading to conservative forecasts as recovery progresses.
- Market Coverage: The report provides an extensive overview of medical devices and relevant regulations across 50 world markets. It includes market size estimates and forecasts to 2025 for the global market, the United States, and key country markets such as China, Japan, India, Brazil, Germany, and Canada.
- Market Drivers and Limiters: Detailed analysis of market drivers and limiters, highlighting the factors influencing market growth and potential obstacles.
- Company Profiles: In-depth profiles of major medical device companies, offering insights into the industry’s leading players.
Medical Device Categories:
This report focuses on specific categories that make up the bulk of the market, including:
- 3D Printing Equipment, Materials, and Software
- Anesthesia Monitors
- Blood Collection
- Blood Gas Analyzers
- Blood Pressure Monitors
- Cannula Respiratory
- Catheters
- Computed Tomography
- Continuous Glucose Monitors
- Coronary Stents
- Cosmetic Surgery Implants
- CPAP Machines
- Defibrillators
- Dental Equipment/Devices (excluding x-ray)
- Dental Implants/Components
- Dental X-ray
- Dialysis Equipment & Supplies
- EKG/ECG Machines
- Electrosurgical Devices
- Endoscopes (excluding gastro)
- Gastric Banding/Bariatric
- Gastro Endoscopes
- Glucose Monitors (excluding CGM)
- Hernia Repair and Fixation Devices
- Hip Implants
- Hypodermic Syringe
- Infusion Pumps
- Insulin Pumps
- Intraocular Lenses
- Knee Implants
- Medical Beds
- Medical Lasers
- Minimally Invasive Surgical Instruments
- MRI
- Neurostimulation
- Ostomy Care Devices
- Oxygen Therapy Equipment
- Pacemakers
- Personal Protective Equipment (gloves, masks, gowns)
- Spine Implants
- Sport, Extremity, and Trauma
- Sterilization/Disinfection Equipment
- Stethoscopes
- Surgical Guidance Devices
- Surgical Robots
- Sutures, Staples, Staplers
- Traditional Surgical Instruments (scalpels, forceps, retractors, scissors)
- Ultrasound
- Vascular Closure Devices
- Wheelchairs
- Wound Care, Advanced
- X-Ray (excluding dental)
Table: Global Markets for Specific Medical Devices, 2020-2025 ($ Billions)
| Device Segment | 2020 | 2025 | CAGR ’20-’25 |
| 3D printing equipment, materials and software | $XX Billion | $XX Billion | XX% |
| Anesthesia Monitors | $XX Billion | $XX Billion | XX% |
| Blood Collection | $XX Billion | $XX Billion | XX% |
| Blood Gas Analyzers | $XX Billion | $XX Billion | XX% |
| Blood Pressure Monitors | $XX Billion | $XX Billion | XX% |
| Cannula Respiratory | $XX Billion | $XX Billion | XX% |
| Catheters | $XX Billion | $XX Billion | XX% |
| Computed Tomography | $XX Billion | $XX Billion | XX% |
| Continuous Glucose Monitors | $XX Billion | $XX Billion | XX% |
| Coronary Stents | $XX Billion | $XX Billion | XX% |
| Cosmetic surgery implants | $XX Billion | $XX Billion | XX% |
| CPAP Machines | $XX Billion | $XX Billion | XX% |
| Defibrillators | $XX Billion | $XX Billion | XX% |
| Dental Equipment/Devices (excluding x-ray) | $XX Billion | $XX Billion | XX% |
| Dental Implants/Components | $XX Billion | $XX Billion | XX% |
| Dental X-ray | $XX Billion | $XX Billion | XX% |
| Dialysis Equipment & Supplies | $XX Billion | $XX Billion | XX% |
| EKG/ECG Machines | $XX Billion | $XX Billion | XX% |
| Electrosurgical Devices | $XX Billion | $XX Billion | XX% |
| Endoscopes (excluding gastro) | $XX Billion | $XX Billion | XX% |
| Gastric Banding/Bariatric | $XX Billion | $XX Billion | XX% |
| Gastro Endoscopes | $XX Billion | $XX Billion | XX% |
| Glucose Monitors (excluding CGM) | $XX Billion | $XX Billion | XX% |
| Hernia Repair and Fixation Devices | $XX Billion | $XX Billion | XX% |
| Hip implants | $XX Billion | $XX Billion | XX% |
| Hypodermic Syringe | $XX Billion | $XX Billion | XX% |
| Infusion Pumps | $XX Billion | $XX Billion | XX% |
| Insulin Pumps | $XX Billion | $XX Billion | XX% |
| Intraocular Lenses | $XX Billion | $XX Billion | XX% |
| Knee implants | $XX Billion | $XX Billion | XX% |
| Medical Beds | $XX Billion | $XX Billion | XX% |
| Medical lasers | $XX Billion | $XX Billion | XX% |
| Minimally Invasive Surgical Instruments | $XX Billion | $XX Billion | XX% |
| MRI | $XX Billion | $XX Billion | XX% |
| Neurostimulation | $XX Billion | $XX Billion | XX% |
| Ostomy Care Devices | $XX Billion | $XX Billion | XX% |
| Oxygen Therapy Equip. | $XX Billion | $XX Billion | XX% |
| Pacemakers | $XX Billion | $XX Billion | XX% |
| Personal protective equipment (gloves, masks, gowns) |
$XX Billion | $XX Billion | XX% |
| Spine implants | $XX Billion | $XX Billion | XX% |
| Sport, Extremity and Trauma | $XX Billion | $XX Billion | XX% |
| Sterilization/disinfection equipment | $XX Billion | $XX Billion | XX% |
| Stethoscopes | $XX Billion | $XX Billion | XX% |
| Surgical Guidance Devices | $XX Billion | $XX Billion | XX% |
| Surgical Robots | $XX Billion | $XX Billion | XX% |
| Sutures, Staples, Staplers | $XX Billion | $XX Billion | XX% |
| Traditional Surgical Instruments (scalpels, forceps, retractors, scissors) |
$XX Billion | $XX Billion | XX% |
| Ultrasound | $XX Billion | $XX Billion | XX% |
| Vascular Closure Devices | $XX Billion | $XX Billion | XX% |
| Wheelchairs | $XX Billion | $XX Billion | XX% |
| Wound Care, Advanced | $XX Billion | $XX Billion | XX% |
| X-Ray (excluding dental) | $XX Billion | $XX Billion | XX% |
| Others | $XX Billion | $XX Billion | XX% |
| Total | $XX Billion | $XX Billion | XX% |
Source: Kalorama Information
For further details and to purchase directly, please contact us.
Table of Contents
Chapter 1: Executive Summary
Overview
Size and Growth of the Market
-
- Figure 1-1: Global Medical Device Market, 2016-2025
Top Companies
Mergers and Acquisitions
Scope and Methodology
Conclusions
Chapter 2: Introduction
Overview
-
- Table 2-1: Summary: Global Atlas of Medical Devices, 2017 Update
Regulation in the United States
Classification of Medical Devices
- Class I Medical Devices
- Limitations on Exemptions
- Table 2-2: Regulations and Product Codes (same regulation number – 21 CFR 870.1875- four different product codes for specific device types with exempt status)
-
- Table 2-3: Medical Device Reclassifications, 2013-2019 (Report December 20, 2019)
- Class II Medical Devices
- Class III Medical Devices
- Device Classification Summary
- Table 2-4: Medical Device Classification Summary (Class I, Class II, Class III)
-
- Figure 2-1: FDA Devices Cleared in 2019/2020 (December 2019 – December 2020), 510(k) Clearances by Month
-
- Figure 2-2: FDA Devices Cleared in 2019/2020 (December 2019 – December 2020), 510(k) Clearances by Review Panel
-
- Table 2-3: FDA 510(k) Premarket Notifications by Bellwether Company and Year (January 2018 – December 2020)
- FDA Launches Early Approval Program (EAP)
- Real-World Data and Real-World Evidence in Device Approval Process
Emergency Use Authorizations for Medical Devices – COVID-19 Related
-
- Table 2-5: EUA for Medical Devices – COVID-19 Related (blood purification devices, continuous renal replacement therapy devices, decontamination systems, infusion pumps, personal protective equipment, remote or wearable patient monitoring devices, respiratory assist devices, other medical devices)
Regulation in Europe
European Union
-
- Table 2-6: EU Medical Device Classification Rules
-
- Table 2-7: EU Medical Device Directives by Device Type
-
- Figure 2-4: EU Competent Authorities
- United Kingdom – Brexit
- European Economic Area
- Figure 2-5: EEA Competent Authorities
- Switzerland
- Turkey
Regulation in Japan
-
- Table 2-8: PMDA Review Categories
Regulation in China
-
- Table 2-9: China’s Medical Device Classification Guide: Passive Devices
-
- Table 2-10: China’s Medical Device Classification Guide: Active Devices
Regulation in Canada
Regulation in Brazil
World Health Care Trends
Unique Device Identifier (UDI)
Chapter 3: Mergers and Acquisitions
Introduction
Selected Significant Device Industry Mergers and Acquisitions
-
- Figure 3-1: Top 10 Highest Valued Medical Device M&A Deals (2015 – 2021 YTD)
Medtronic Acquires Covidien and Other Companies
Abbott: Acquisitions, Divestitures and the Alere Deal
BD Acquires CareFusion; Following with C.R. Bard
Pfizer and the $17 Billion Hospira Acquisition
Zimmer Finalizes Biomet Acquisition
Cardinal Health Strengthens Position in Medical Device Market with Medtronic Asset Acquisition
Canon Medical Increases Imaging Portfolio with Toshiba Medical Systems Acquisition
Dentsply-Sirona Merger
Johnson & Johnson and Abbott Medical Optics: Combined #2 in Vision Care Industry; LifeScan Divesture
Thermo Fisher Scientific Completes Major Deals in 2016
Danaher and Cepheid: Expanding Access to Molecular Diagnostic Technologies
Tornier and Wright Medical Merger Finalized
Stryker Corporation Active in M&A – Integrating Wright Medical
- Wright Medical Stryker Corp. and Wright Medical: $4.7 Billion Opportunity
Hill-Rom Completes Acquisition of Welch Allyn
PerkinElmer and EUROIMMUN Medical Laboratory Diagnostics AG
Siemens Healthineers and Epocal Inc (Alere subsidiary)
Integra LifeSciences and Codman Neurosurgery from Johnson & Johnson
Fresenius Medical Care and NxStage Medical
AbbVie and Allergan – A $63 Billion Deal
Genomic Health and Exact Sciences
Siemens Healthineers and Corindus Vascular Robotics
3M buys Aceility for $6.7 Billion Expanding Wound Care Portfolio
Philips combined with BioTelemetry – Improves Cardiac Monitoring and Product Offerings
Closed April 15, 2021: Largest Announced Deal of 2020 – Siemens Healthineers grabs Varian Medical Systems
-
- Table 3-1: Mergers and Acquisitions in the Medical Device Market – Valued at $100 Million or More, 2015-2020 and January-April 2021 (includes pending deals)
-
- Figure 3-2: Medical Device M&A Combined Value by Year (2015-2020, January-April 2021 and Select Pending Deals)
Pending: Steris to Boost Infection Prevention Portfolio with Cantel Medical Acquisition
Pending with Opposition from FTC: Illumina Bids to Acquire GRAIL for $8 billion
Pending: Diagnostic Testing Leader Roche to Expand Capabilities with Acquisition of Gen Mark Diagnostics
Terminated: Thermo Fisher and Qiagen
Chapter 4: Specific Device Markets
-
- Table 4-1: Global Markets for Specific Medical Devices, 2020-2025 ($ Billions)
Blood Collection Supplies
Catheters
CPAP Devices
Critical Care Analysis – Blood Gas Analyzers
Defibrillators
-
- Figure 4-1: Defibrillation Device Sales, Distribution by Type, 2020 (%)
Diabetes Management Devices
-
- Figure 4-2: Diabetes Management Device Market, Distribution by Segment, 2020
Glucose Monitor and Consumable Market Value (2020): $14.9 billion
-
- Figure 4-3: Glucose Monitoring Device Market Trend by Product Type, 2015-2025 ($ millions)
Insulin Delivery Pump Market Value (2020): $3.5 billion
Dialysis Equipment & Supplies
-
- Figure 4-4: Patient Distribution, Hemodialysis vs. Peritoneal Dialysis, 2020 (%)
Endoscopes
-
- Table 4-2: Endoscopes and Related Instrument Market Size by Subsegment, 2020
Gastric Banding and Bariatric Devices
Hernia Repair and Fixation Devices
Hip Implants
Infusion Pumps
Intraocular Lens Devices
Knee Implants
- Posterior-Stabilized Knee Implants
- Cruciate-Retaining Knee Implants
- Unicompartmental Knee Implants
Medical Beds
Minimally Invasive Surgery (MIS)
MRI
Nasal Cannula
Ostomy Products
Pacemakers
-
- Figure 4-5: Pacemaker Device Sales, Distribution by Type, 2020 (%)
Patient Monitoring
-
- Figure 4-6: Distribution of Patient Monitoring Technologies by Type: 2020
Personal Protective Equipment
-
- Figure 4-7: Market Distribution of PPE by Type, 2020
-
- Figure 4-8: World Health Organization, Estimated Demand for PPE by Month, COVID-19 Impact (units in millions)
Medical Gloves Market Value (2020): $6.4 billion
Medical Mask/Face Protection Market Value (2020): $3 billion
Stents
Sterilization and Disinfection Equipment
Ultrasound
Wheelchairs
Wound Care Devices, Advanced Technologies
X-Ray and Digital X-Ray
-
- Figure 4-9: X-Ray Equipment Sales, Distribution by Type, 2020 (%)
Chapter 5: Bellwether Companies
Overview
Revenue Performance – 15 Bellwether Companies
-
- Table 5-1: Revenue Performance, Bellwether Companies, 2019 vs. 2020 (US billions)
-
- Figure 5-: Market Performance by Bellwether Company, 2019-2020
US Versus International Sales
-
- Table 5-2: Percent of Sales from US, 2019 and 2020
-
- Figure 5-: Percent of Sales from US, 2019 vs 2020
Investment in Research and Development
-
- Table 5-3: Research and Development Spending, Bellwether Companies, 2019 and 2020 (US billions)
-
- Table 5-4: Research and Development Spending as a Percentage of Revenues, Bellwether Companies, 2019 and 2020
Chapter 6: Market Analysis
- 6-1: Market Influence: Strength of Impact
Market Drivers
Aging Population
-
- Figure 6-2: Global Population Trends, Total Population vs. Age 65+ Population, 2000-2050
Increase in Chronic Disease
-
- Figure 6-3: Global Prevalence of Disease, 2000, 2015 and Projected 2030
-
- Figure 6-4: Mortality: Chronic vs. Acute, 2015
Market Constraints
Pressure on Prices
-
- Figure 6-5: Medical Device Spending as a Percentage of Total Health Spending, by Country, 2019 Estimates
Group Purchasing Organization
Value Analysis Committees
State of the US Hospital Market
-
- Figure 6-6: Major U.S. Hospital Chain 2015-2020 Results: Revenue, Net Income, Salaries, Supply Spending
Pricing Transparency in the Hospital
Interoperability and Exchange of Patient Health Information
Medical Device Size and Growth
-
- Figure 6-7: Medical Device Market, 2019-2020 YOY Change by Broad Segment (%)
-
- Figure 6-8: Medical Device Market, 2016-2025
Market by Region
-
- Figure 6-9: Medical Device Market Distribution by Region, 2020 (Northern America, EMEA, Asia Pacific, Latin America)
Market by Country: Top 20
-
- Table 6-1: Top 20 Device Markets by Country, 2020-2025 ($ billions)
-
- Figure 6-9: Medical Device Market Growth, CAGR 2020-2025 by Top 20 Country
United States Medical Device Market
-
- Figure 6-10: United States Medical Device Market Indicators
-
- Figure 6-11: United States Medical Device Market: Distribution of Revenues, 2020
Japan Medical Device Market
-
- Figure 6-12: Japan Medical Device Market Indicators
-
- Figure 6-13: Japan Medical Device Market: Distribution of Revenues, 2020
Germany Medical Device Market
-
- Figure 6-14: Germany Medical Device Market Indicators
-
- Figure 6-15: Germany Medical Device Market: Distribution of Revenues, 2020
China Medical Device Market
-
- Figure 6-16: China Medical Device Market Indicators
-
- Figure 6-17: China Medical Device Market: Distribution of Revenues, 2020
France Medical Device Market
-
- Figure 6-18: France Medical Device Market Indicators
-
- Figure 6-19: France Medical Device Market: Distribution of Revenues, 2020
United Kingdom Medical Device Market
-
- Figure 6-20: United Kingdom Medical Device Market Indicators
-
- Figure 6-21: United Kingdom Medical Device Market: Distribution of Revenues, 2020
Italy Medical Device Market
-
- Figure 6-22: Italy Medical Device Market Indicators
-
- Figure 6-23: Italy Medical Device Market: Distribution of Revenues, 2020
Brazil Medical Device Market
-
- Figure 6-24: Brazil Medical Device Market Indicators
-
- Figure 6-25: Brazil Medical Device Market: Distribution of Revenues, 2020
Spain Medical Device Market
-
- Figure 6-26: Spain Medical Device Market Indicators
-
- Figure 6-27: Spain Medical Device Market: Distribution of Revenues, 2020
Canada Medical Device Market
-
- Figure 6-28: Canada Medical Device Market Indicators
-
- Figure 6-29: Canada Medical Device Market: Distribution of Revenues, 2020
India Medical Device Market
-
- Figure 6-30: India Medical Device Market Indicators
-
- Figure 6-31: India Medical Device Market: Distribution of Revenues, 2020
Australia Medical Device Market
-
- Figure 6-32: Australia Medical Device Market Indicators
-
- Figure 6-33: Australia Medical Device Market: Distribution of Revenues, 2020
Russia Medical Device Market
-
- Figure 6-34: Russia Medical Device Market Indicators
-
- Figure 6-35: Russia Medical Device Market: Distribution of Revenues, 2020
The Netherlands Medical Device Market
-
- Figure 6-36: Netherlands Medical Device Market Indicators
-
- Figure 6-37: Netherlands Medical Device Market: Distribution of Revenues, 2020
Switzerland Medical Device Market
-
- Figure 6-38: Switzerland Medical Device Market Indicators
-
- Figure 6-39: Switzerland Medical Device Market: Distribution of Revenues, 2020
Mexico Medical Device Market
-
- Figure 6-40: Mexico Medical Device Market Indicators
-
- Figure 6-41: Mexico Medical Device Market: Distribution of Revenues, 2020
Taiwan Medical Device Market
-
- Figure 6-42: Taiwan Medical Device Market Indicators
-
- Figure 6-43: Taiwan Medical Device Market: Distribution of Revenues, 2020
South Korea Medical Device Market
-
- Figure 6-44: South Korea Medical Device Market Indicators
-
- Figure 6-45: South Korea Medical Device Market: Distribution of Revenues, 2020
Sweden Medical Device Market
-
- Figure 6-46: Sweden Medical Device Market Indicators
-
- Figure 6-47: Sweden Medical Device Market: Distribution of Revenues, 2020
Turkey Medical Device Market
-
- Figure 6-48: Turkey Medical Device Market Indicators
-
- Figure 6-49: Turkey Medical Device Market: Distribution of Revenues, 2020
Second Tier: Market by Country
-
- Table 6-2: Countries 21-50: Country Device Markets, 2020-2025 ($ billions)
Chapter 7: Company Profiles: Bellwether
Medtronic
-
- Table 7-1: Medtronic Corporate Summary
Company Overview
Products Highlights
Company Financials
-
- Table 7-2: Medtronic Financial Review, Fiscal 2018-2020 ($billions)
Johnson & Johnson
-
- Table 7-3: Johnson & Johnson Corporate Summary
Company Overview
- Advanced Sterilization Products (ASP)
- Auris Health, Inc. Acquisition
- LifeScan, Inc. Divestiture
- Abbott Medical Optics
- Cordis Divestiture
- Coherex Medical, Inc.
- NeuWave Medical
Product Overview
Company Financials
-
- Table 7-4: Johnson & Johnson Financial Review 2018-2020 ($ billions)
Abbott Laboratories
-
- Table 7-5: Abbott Corporate Summary
Company Overview
- Cephea Valve Technologies Acquisition
- St Jude Medical Acquisition
- Alere Acquisition
Products
Company Financials
-
- Table 7-6: Abbott Financial Review, 2018-2020 ($billions)
Becton Dickinson and Co. (BD)
-
- Table 7-7: Becton Dickinson Corporate Summary
Company Overview
Products
Company Financials
-
- Table 7-8: Becton Dickinson Financial Review, 2018-2020 ($ billions)
Siemens Healthineers
-
- Table 7-9: Siemens Healthineers Corporate Summary
Company Overview
Products
Company Financials
-
- Table 7-10: Siemens Healthineers Financial Review, 2018-2020 ($ billions)
Cardinal Health
-
- Table 7-11: Cardinal Health Corporate Summary
Company Overview
Products
Company Financials
-
- Table 7-12: Cardinal Health Financial Review, 2018-2020 ($ billions)
Royal Philips
-
- Table 7-13: Royal Philips Corporate Summary
- Company Overview
Products
Company Financials
-
- Table 7-14: Philips Financial Review, 2018-2020 ($billions)
Roche
-
- Table 7-15: Roche Corporate Summary
Company Overview
Products
Company Financials
-
- Table 7-16: Roche Financial Review, 2018-2020 ($billions)
Stryker Corporation
-
- Table 7-17: Stryker Corporate Summary
Company Overview
Products
Company Financials
-
- Table 7-18: Stryker Corporation Financial Review, 2018-2020 ($ billions)
GE Healthcare
-
- Table 7-19: GE Healthcare Corporate Summary
Company Overview
Products
Company Financials
-
- Table 7-20: GE Healthcare Financial Review, 2018-2020 ($ billions)
Boston Scientific Corp.
-
- Table 7-21: Boston Scientific Corporate Summary
Company Overview
Products
Company Financials
-
- Table 7-22: Boston Scientific Financial Review, 2018-2020 ($billions)
Danaher Corp.
-
- Table 7-23: Danaher Corporate Summary
Company Overview
Company Financials
-
- Table 7-24: Danaher Financial Review, 2018-2020 ($billions)
Baxter International, Inc.
-
- Table 7-25: Baxter Corporate Summary
Company Overview
Products
Company Financials
-
- Table 7-26: Baxter Financial Review, 2018-2020 ($ billions)
Zimmer Biomet Holdings, Inc.
-
- Table 7-27: Zimmer Biomet Corporate Summary
Company Overview
Products
Company Financials
-
- Table 7-28: Zimmer Biomet Financial Review, 2018-2020 ($ billions)
- Braun Melsungen AG
-
- Table 7-29: B. Braun Corporate Summary
Company Overview
Products
Company Financials
-
- Table 7-30: B. Braun Financial Review, 2018-2020 ($ billions)
8: Other Market Participants
3M
Alcon
Asahi Kasei
Canon Medical Systems
Coloplast A/S
ConvaTec
Dentsply-Sirona
Drägerwerk AG & Co. KGaA
Fresenius SE & Co. KGaA
Hill-Rom
Masimo Corporation
Mindray Bio-Medical Electronics Co., Ltd.
Mölnlycke Health Care AB
Nova Biomedical
Olympus Corporation
PerkinElmer, Inc
ResMed
Smith & Nephew plc.
Smiths Group
Steris plc
Teleflex Inc
Terumo Corporation
Varian Medical Systems, Inc.
Vyaire Medical
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