25 results · 20ms · Sources: EU EUDAMED, US FDA

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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