8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Racz Neurostat RF Generator
FDA 510(k)
FDA Class 2
·Neurology
REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH
FDA 510(k)
FDA Class 2
·Cardiovascular
TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES
FDA 510(k)
FDA Class 2
·Orthopedic
MINICAP
FDA Adverse Event
BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 2, 2011
12/14 ARTICUL 40MM M SPEC+1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·November 6, 2014
STERIS SYSTEM 1E
FDA Adverse Event
STERIS CORPORATION - HOPKINS·Product code MED·July 18, 2013
RotoProne Therapy System, Model 209500, Device List Number E232632 Product is designed to allow patients to be mechanically rotated to the prone position and provides kinetic therapy to patients. It is intended for the treatment and prevention of pulmonary complications associated with immobility.
FDA Recall
Terminated
·KCI USA, Inc.·Product code IKZ·September 9, 2010
MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds
FDA Enforcement
Class II
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·February 25, 2026