75 results · 25ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES

FDA 510(k)
FDA Class 2 ·Cardiovascular

Comprehensive® Shoulder System

FDA UDI
Biomet Orthopedics, LLC·00887868267758·

COMPREHENSIVE SHOULDER SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304449756·

SIMPLEABI

FDA 510(k)
FDA Class 2 ·Radiology

DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Immunology

VERSA-DIAL 46X18X53 HUMERAL HEAD

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code MBF·December 8, 2016

MD HYBRID GLENOID BASE 4MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWS·December 8, 2016

COMPREHENSIVE SHOULDER SYSTEM STANDARD TAPER ADAPTOR

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code MBF·December 8, 2016

BD MICRO-FINE¿ IV INSULIN SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·December 26, 2018

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 14, 2024

CRYSTALENS ACCOMODATING IOL

FDA Adverse Event
Injury ·BAUSCH + LOMB·Product code NAA·May 9, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 24, 2014

LINOX S 65

FDA Adverse Event
Malfunction ·BIOTRONIK SE & CO. KG·Product code LWS·May 24, 2011

COMP PRIMARY STEM 8MM MINI, model # 113628

FDA Recall
Terminated ·Zimmer Biomet, Inc.·Product code MBF·June 5, 2017

COMP PRIMARY STEM 8MM MINI, model # 113628

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·January 10, 2018

COMPREHENSIVE PT HYBRID GLEN POST REGENEREX

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWS·October 24, 2017

VERSA-DIAL/COMPREHENSIVE 46X18X53 HUMERAL HEAD

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code MBF·October 24, 2017

SM HYBRID COMPREHENSIVE GLENOID BASE 4MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWS·October 24, 2017

VERSA-DIAL/COMPREHENSIVE TI STD TAPER

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code MBF·October 24, 2017

COMPREHENSIVE VERSA-DIAL HUMERAL HEAD

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code MBF·May 29, 2018