25 results
·
20ms
·
Sources: EU EUDAMED, US FDA
TINA-QUANT ALBUMIN GEN.2
FDA 510(k)
FDA Class 2
·Immunology
8960 MASK
FDA UDI
HANS RUDOLPH, INC.·00817136020716·8960 PED SM MASK W/MED 2600 2W
16PW - Piedmont Natural Gas - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588130729·16PW - Piedmont Natural Gas - Poly White
CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)
FDA 510(k)
FDA Class 2
·Orthopedic
REVERE SACRAL PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Widex
FDA UDI
Widex A/S·05706069664027·Widex UNIQUE U-PA 110 DEMO (Winter silver ) RC ...
Widex
FDA UDI
Widex A/S·05706069658217·Widex DREAM D-FA P 110 DEMO (Winter silver ) Te...
AGX
FDA UDI
Widex A/S·05706069669084·Audigy AGXWD-FS (Winter silver ) Telecoil, RC coil
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code PAH·May 15, 2013
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code ITI·September 24, 2014
CAPSURE EPI
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DTB·June 3, 2011
ADVIA CENATUR XP FT4
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEC·December 1, 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 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