470 results
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30ms
·
Sources: EU EUDAMED, US FDA
CPK REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902097188·DISTRACTOR 9112416 SGL BARREL 18/12MM OS
n/a
FDA UDI
HANS RUDOLPH, INC.·00874750006328·2630C 2WAY Y NRBV MED 1.125 MP
Chisel
FDA UDI
ELLIQUENCE, LLC·00846338002862·
TLIF/PLIF Disc Prep
FDA UDI
Life Spine, Inc.·00190837087036·
CONFOSCAN 2 CONFOCAL MICROSCOPE
FDA 510(k)
FDA Class 2
·Ophthalmic
BD GENEOHM VANR ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
Gibralt
FDA UDI
Choice Spine, LP·00840996169394·GIBRALT,DRILL,FIXED,2.4X16
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 23, 2025
GMK-SPHERE PATELLA RESURFACING SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 25, 2024
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 14, 2019
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code JWH·November 21, 2025
GMK SPHERE FEMORAL COMPONENT SIZE 4 LEFT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 3, 2016
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 22, 2021
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 10, 2021
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 2, 2025
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 30, 2026
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 26, 2019
M2A-MAGNUM 42-50MM TPR INSRT-6
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 14, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014