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

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LED light therapy mask (FM-01, FM-02, FM-03)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

GLOBAL CAP CTA

FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295105435·GLOBAL C.A.P. CTA CUTTING BLOCK SIZE 44

GLOBAL CAP CTA

FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295105411·GLOBAL C.A.P. CTA CTA HEAD TRIAL 44 X 15

GLOBAL CAP CTA

FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295105428·GLOBAL C.A.P. CTA CTA HEAD TRIAL 44 x 18

GENZYME CONTRAST II HCG URINE/SERUM TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

GMK SPHERE CEMENTLESS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·May 25, 2026

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 21, 2024

GMK 3D METAL TIBIAL TRAY

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 12, 2025

GMK SPHERIKA CEMENTLESS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·March 16, 2026

RIATA ACTIVE FIXATION

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008

COMPRESSOR MINI

FDA Adverse Event
Malfunction ·MAQUET CRITICAL CARE AB·Product code BTI·July 29, 2011

EASYTRAK 3

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code OJX·July 12, 2013

GMK SPHERIKA CEMENTLESS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·December 19, 2025

GMK SPHERIKA CEMENTLESS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·December 24, 2025

GMK 3D METAL TIBIAL TRAY

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 11, 2025

GMK 3D METAL TIBIAL TRAY

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 29, 2025

SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

FDA Enforcement
Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

FDA Enforcement
Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026