10 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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