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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS)

FDA 510(k)
FDA Class 1 ·Clinical Toxicology

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B16740818550·

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B1674081855060·

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X0818550·8mm H x 18mm W x 55mm L x 0 degrees XLIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X08185580·8mm H x 18mm W x 55mm L x 8 degrees XLIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587L081855120·8mm H x 18mm W x 55mm L XLIF Trial 12 degree Lo...

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X081855120·8mm H x 18mm W x 55mm L x 12 degrees XLIF

Zavation

FDA UDI
Zavation LLC·00842166154148·8x18X55mm, 12°, MILC

ZEUS-L

FDA UDI
SPINAL ELEMENTS·00840916120887·ZEUS®-L Implant, 8 x 18 x 55mm, Parallel

ZEUS-L

FDA UDI
SPINAL ELEMENTS·00840916120870·ZEUS®-L Implant, 8 x 18 x 55mm, Lordotic

Zavation

FDA UDI
Zavation LLC·00842166149816·8x18x55mm, 0°, MILC

Zavation

FDA UDI
Zavation LLC·00842166150560·8x18x55mm, 6°, MILC

TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)

FDA 510(k)
FDA Class 1 ·General Hospital

WAMPOLE HS-CRP ELISA

FDA 510(k)
FDA Class 2 ·Immunology

INTERMATE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·April 29, 2013

ISYMM ASPHERIC INTRAOCULAR LENS

FDA Adverse Event
Malfunction ·HOYA SURGICAL OPTICS, INC.·Product code HQL·April 5, 2011

CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code KRH·July 22, 2008

ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LCP·August 7, 2014

ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LCP·August 7, 2014

ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LCP·August 7, 2014