22 results · 24ms · Sources: EU EUDAMED, 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