25 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Solitaire Platinum Revascularization Device
FDA 510(k)
FDA Class 2
·Cardiovascular
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100196·MCINTYRE SPECULUM OPEN WIRE
SYNTHECEL DURA REPLACEMENT DEVICES
FDA 510(k)
FDA Class 2
·Neurology
VASHE SKIN AND WOUND HYDROGEL
FDA 510(k)
FDA Unclassified
·Unknown
Widex
FDA UDI
Widex A/S·05706069792966·Widex UNIQUE U-PA (Cappuccino brown ) 100, RC coil
Widex
FDA UDI
Widex A/S·05706069819069·Widex UNIQUE U-FS (Cappuccino brown ) 100, Tele...
ORS-100N SOLUTION WARMER DRAPE
FDA Adverse Event
Malfunction
·MICROTEK DOMINICANA, S.A.·Product code LHC·June 16, 2016
ECOLAB
FDA Adverse Event
ECOLAB·Product code LHC·June 17, 2016
ECOLAB
FDA Adverse Event
ECOLAB·Product code LHC·June 17, 2016
PROTECTA XT VR
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code LWS·June 8, 2013
VALIANT CAPTIVIA STENT GRAFT
FDA Adverse Event
Death
·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·June 29, 2011
VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM 6
FDA Adverse Event
Injury
·GUIDANT CARDIAC SURGERY·Product code GEI·September 8, 2008
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
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
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
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
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
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 Recall
Terminated
·Synthes (USA) Products LLC·Product code GXQ·December 8, 2015
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 Recall
Terminated
·Synthes (USA) Products LLC·Product code GXQ·December 8, 2015
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 Recall
Terminated
·Synthes (USA) Products LLC·Product code GXQ·December 8, 2015