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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

AccuFit Lateral Plate System

FDA 510(k)
FDA Class 2 ·Orthopedic

Sklar®

FDA UDI
SKLAR CORPORATION·10649111084447·S E METZ SCISS CVD DEL 10" TC

REACH(R) FEMORAL PROVISIONAL

FDA UDI
Biomet Orthopedics, LLC·00880304306998·

BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

FDA 510(k)
FDA Class 1 ·Microbiology

CRUISER 18 GUIDEWIRE

FDA 510(k)
FDA Class 2 ·Cardiovascular

TRUEMETRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·March 20, 2019

TRIATHLON-CR FEMORAL COMPONENTCEMENTED #4 LEFT

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·July 7, 2011

STENOSCOP

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 3, 2013

ANALYTICAL D MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·September 16, 2008

QUADRA H FEMORAL STEMS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·November 18, 2025

NAVIGABLE HANDLE FOR USE WITH ACCESS CANNULA

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code HAW·April 19, 2017

Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017

Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024