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