14 results · 31ms · Sources: EU EUDAMED, US FDA

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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