10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Anatase Spine Surgery Navigation System
FDA 510(k)
FDA Class 2
·Neurology
DELTA XTEND
FDA UDI
DEPUY (IRELAND)·10603295116363·DELTA Xtend HUMERAL IMPLANT DRIVER
10 ML BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·February 25, 2021
ClariPulmo
FDA 510(k)
FDA Class 2
·Radiology
FRONTIER MODEL X5
FDA 510(k)
FDA Class 2
·Physical Medicine
UNKNOWN ZIMMER ELBOW
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JDB·August 23, 2011
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG
FDA Adverse Event
Malfunction
·COSTA RICA·Product code LTI·November 5, 2008
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013
CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # D190549.
FDA Enforcement
Class II
·Terminated·Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables·December 28, 2016
HUMERAL IMPLANT DRIVER
FDA Adverse Event
Malfunction
·DEPUY FRANCE SAS 3003895575·Product code HWR·November 10, 2016