470 results · 30ms · Sources: EU EUDAMED, US FDA

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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