14 results
·
31ms
·
Sources: EU EUDAMED, US FDA
SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Damon 3
FDA UDI
ORMCO CORPORATION·00889989003413·U1R DAMON 3 .022 +7/+5/0
GSS610N21 Series Steam Sterilizer
FDA 510(k)
FDA Class 2
·General Hospital
TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
UNKNOWN DEPUY SZ4 MBT TIBIAL TRAY
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·December 1, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 3, 2014
DEXTRUS 4136
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVZ·December 7, 2012
VANGUARD COMPLETE KNEE SYSTEM - PS OPEN INTL FEM-LT 75
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·March 24, 2017
BIOMET TIBIAL TRAYS - CC CRUCIATE TRAY 83MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·March 24, 2017
VANGUARD COMPLETE KNEE SYSTEM - PS OPEN INTL FEM RT 75
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·March 24, 2017
BIOMET CC CRUCIATE TRAY 83MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 23, 2017
VANGUARD COMPLETE KNEE SYSTEM- PS OPEN INTL FEM-LT 75
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 23, 2017
BIOMET TIBIAL TRAYS - CC CRUCIATE TRAY 83MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·March 24, 2017
BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020