13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UNIMED BLOOD PRESSURE CUFF
FDA 510(k)
FDA Class 2
·Cardiovascular
Operator's Manual Flexibility Philips
FDA UDI
Noras MRI products GmbH·04251269203817·
Operator's Manual Flexibility Philips
FDA UDI
Noras MRI products GmbH·04251269200694·
VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY
FDA 510(k)
FDA Class 2
·General Hospital
GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/12MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 13, 2017
HI-TORQUE WHISPER GUIDE WIRE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code DQX·May 14, 2013
SET SCREW, TI GAMMA3® Ø8X17.5MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·September 24, 2014
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 25, 2011
WALLFLEX? BILIARY TRANSHEPATIC
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code FGE·August 21, 2012
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025