11 results
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18ms
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Sources: EU EUDAMED, US FDA
CAT. 7-EAR, NOSE & THROAT DEVICES
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78403111·Micro Sprint Bracket Roth .022" max. 3 right w....
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78403111001·Micro Sprint Bracket Roth .022" max. 3 right w....
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78403110101·Micro Sprint Bracket Roth .022" max. 3 right w....
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78403110051·Micro Sprint Bracket Roth .022" max. 3 right w....
CARESITE LUER ACCESS DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
SHIAN JIA MEEI DIGATAL PWN TENS, MODEL YW-6000/UC-332/UC-330/ST-331
FDA 510(k)
FDA Class 2
·Neurology
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (CE)·Product code MCX·November 20, 2012
INTERSTIM
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 30, 2014
PATIENT ROOM WALL SAVER RECL
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIVISION·Product code FRK·September 10, 2010
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·April 20, 2016