57 results
·
32ms
·
Sources: EU EUDAMED, US FDA
AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
N/A
FDA UDI
HANS RUDOLPH, INC.·00874750003013·77 V2 ASSY MEDIUM 22ID W/HG
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024493872·
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00846795002115·
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837045104·Paddle Shaver, 9mm
Baby Gorilla®/Gorilla® Plating System
FDA UDI
Paragon 28, Inc.·00889795111272·Gorilla, Tap, Cortical Ø3.5mm
IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code MQR·April 12, 2018
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 13, 2023
UNKNOWN DEPUY PINNACLE ACETABULAR LINER
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JDI·May 15, 2013
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014
LAMITRODE S8 SURGICAL LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 31, 2011
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 13, 2021
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 5, 2020
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 18, 2025
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 28, 2020
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 27, 2019
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 3, 2026
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 7 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 28, 2022