41 results · 22ms · Sources: EU EUDAMED, US FDA

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CARESTREAM Vue PACS

FDA 510(k)
FDA Class 2 ·Radiology

AGC Knee System

FDA UDI
Biomet Orthopedics, LLC·00880304243057·

New Image

FDA UDI
HOLLISTER INCORPORATED·00610075078486·2-Piece Ostomy Skin Barrier, Convex, CeraPlus

Kirwan

FDA UDI
KIRWAN SURGICAL PRODUCTS LLC·00841019103845·Titanium Bipolar Coagulation Forceps 4 1/4" (10...

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100295·FRANKEL INFANT EYE SPECULUM

PRESSON ELECTRODE

FDA 510(k)
FDA Class 2 ·Neurology

INTERFACE

FDA 510(k)
FDA Class 2 ·Dental

ONE TOUCH

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·January 15, 2002

SURESTEP

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CGA·August 25, 1999

CARELINK PROGRAM W/TELEMETRY C

FDA Adverse Event
Malfunction ·RICE CREEK MFG·Product code DXY·June 8, 2013

SYNCHROMED II

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·June 22, 2011

CRYSTALENS

FDA Adverse Event
Injury ·EYEONICS, INC.·Product code HQL·September 8, 2008

RHK CEMENTED STEM

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code JWH·March 6, 2019

RHK CEMENTED STEM

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code JWH·March 6, 2019

ProScreen CLIA Wvd 12 Panel Cup w/Adult., Item No. PSCupA-12M-W

FDA Enforcement
Class III ·Terminated·Ameditech Inc·December 30, 2015

BIOMET OFFSET TIBIAL TRAY ADAPTOR

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code JWH·March 6, 2019

RHK 12X80 CEMENTED STEM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code JWH·April 9, 2019

RHK 10X80 CEMENTED STEM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code JWH·April 9, 2019

VNGD SSK PSC INTLK FMRL 60 RT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 30, 2022

VANGUARD SSK FEMORAL COMPONENT

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code JWH·August 3, 2018