20 results · 23ms · Sources: EU EUDAMED, US FDA

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Integrity Implant

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

ENDER NAIL

FDA UDI
Smith & Nephew, Inc.·03596010104502·3.5MM DIAMETER NAIL 3.5MMX38CM ...

OsteoMed

FDA UDI
OSTEOMED LLC·00845694021425·FPS 3.5mm x 38mm Locking Screw

OsteoMed

FDA UDI
OSTEOMED LLC·00845694075886·FPS 3.5 x 38mm Locking Screw Sterile Qty 2

EPIEN ROOT CANAL CLEANSER

FDA 510(k)
FDA Unclassified ·Unknown

TIMEX ACCUCURVE TALKING 30 SECOND THERMOMTER

FDA 510(k)
FDA Class 2 ·General Hospital

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

JUVEDERM ULTRA XC TSK US

FDA Adverse Event
Injury ·ALLERGAN·Product code LMH·October 29, 2014

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011

JAGWIRE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code EZB·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

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

FDA Enforcement
Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

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