73 results · 22ms · Sources: EU EUDAMED, US FDA

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BIOPLEX 2200 EBV IGM KIT

FDA 510(k)
FDA Class 1 ·Microbiology

SCHWERT

FDA UDI
A. Schweickhardt GmbH & Co. KG·E8961230210·Bone graft holding and drilling forceps 20cm, ...

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K1430210·Rod Template, 500mm

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K1230010·Rod Holder, Straight, 5.5 mm

ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T

FDA 510(k)
FDA Class 2 ·Orthopedic

GMK-SPHERE REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 21, 2019

OPTICROSS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·August 22, 2025

OPTICROSS

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·September 23, 2025

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 21, 2013

530G INSULIN PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OZO·September 26, 2014

CONCERTO CRT-D DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code NIK·June 14, 2011

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 8, 2014

GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 14, 2018

GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/20MM

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·April 8, 2016

GMK-REVISION FEMUR REVISION PS SIZE 2 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 2, 2019

GMK-REVISION FEMUR CEMENTED STD SIZE 5NARROW / RIGHT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 7, 2018

GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/10MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 6, 2018

GMK REVISION TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 26, 2025

GMK PRIMARY TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 28, 2024