22 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Centurion POCT System
FDA 510(k)
FDA Class 2
·Orthopedic
HHM
FDA UDI
Oticon A/S·05707131281647·H150V2, BTE 13 WL 100 STG HHM
BIOMET KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304207820·
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00887868344299·
Alleset
FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918152233·Lap Tray_blue_555x200mm_Non-sterilze/in bulk_60...
XPERT MRSA/SA NASAL ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, ST
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 12, 2025
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code MTA·June 6, 2013
BEQ-HMOD70000-USA#QUADROX-ID AD.O.FIL.
FDA Adverse Event
Injury
·MAQUET CARDIOPULMONARY AG·Product code DTZ·September 9, 2014
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 21, 2011
RINGLOC-X E1 H/W 56/32MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·April 11, 2025
AGC DA2000 KN TIB BRG 79/83X10
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·May 7, 2024
OSS 7CM SEGMENTAL FEMORAL RT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·September 9, 2020
OSS CEMENTED IM STEM 13X150
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·September 9, 2020
BIOMET REGENEREX PRIMARY TIBIAL TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 9, 2018
REFOBACIN PLUS BONE CEMENT 20X2
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MBB·July 15, 2024
OSS TIBIAL POLY BEARING 12MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·August 7, 2020
REFOBACIN BONE CEMENT R 1X40G
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MBB·October 12, 2020
various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·April 26, 2017