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

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LINQ II Insertable Cardiac Monitor

FDA 510(k)
FDA Class 2 ·Cardiovascular

CoRoent

FDA UDI
Nuvasive, Inc.·00887517569196·CoRoent Ant TLIF Ti, 11x11x30mm 4°

Luna

FDA UDI
ULTRADENT PRODUCTS, INC.·00883205003195·Luna Opal R Mini .018 UR2 (+8°T +9°A)

Comprehensive SRS

FDA UDI
Biomet Orthopedics, LLC·00880304714809·

PMT® Halo Systems

FDA UDI
PMT CORPORATION·00650551135852·HALO, 1203-5 VEST X-LARGE, ACRYLIC LINER, 1211-...

OPTIMA XR120

FDA 510(k)
FDA Class 2 ·Radiology

OB-1 FETAL MONITOR

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

GMK TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 22, 2025

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·UNKNOWN·Product code IOR·October 29, 2014

ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

FDA Adverse Event
Injury ·COOK, INC.·Product code MIH·August 3, 2011

STERRAD 200, SINGLE DOOR

FDA Adverse Event
Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·July 8, 2013

GMK TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 22, 2026

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 7, 2024

I-STAT EC8+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code CHL·October 13, 2021

GMK PRIMARY TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 21, 2025

GMK TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 3, 2026

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 17, 2025

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 13, 2025

GMK-SPHERIKA 02.07.1204L TIBIAL TRAY FIX CEMENTED S.4L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 10, 2023

GMK-SPHERIKA TIBIAL TRAY FIXED CEMENTED SIZE 5 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 17, 2024