10 results · 27ms · Sources: EU EUDAMED, US FDA

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MTP ARTHROPUMP DISPOSABLE TUBING SET

FDA 510(k)
FDA Class 2 ·Orthopedic

AETOS Shoulder System

FDA UDI
Smith & Nephew, Inc.·00885556882719·GENERAL INSTRUMENT TRAY V2 BASE ASSEMBLY

Physica KR Liner and SMR Reverse Humeral Liner

FDA 510(k)
FDA Class 2 ·Orthopedic

IST SNORING APPLIANCE

FDA 510(k)
FDA Class 2 ·Dental

OMNIFIT AXIAL REAMER

FDA Adverse Event
Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LXH·March 6, 2013

INJECTOR, OPTIVANTAGE DH

FDA Adverse Event
Injury ·LIEBEL-FLARSHEIM CO.·Product code IZQ·February 8, 2011

CONSULTA CRT-D

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·August 8, 2014

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N; 4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM NUMBER MIAH65B; 5)DR WHIDD0N TOTAL HIP CPP, MODEL/ITEM NUMBER MPWH01B; 6)KNEE ARTHROSCOPY, MODEL/ITEM NUMBER SPKA57T; 7)ANTERIOR HIP PACK, MODEL/ITEM NUMBER WVAH40H.

FDA Enforcement
Class II ·Ongoing·American Contract Systems Inc·September 3, 2025

Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021