2,938 results · 25ms · Sources: EU EUDAMED, US FDA

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HATCH KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Ophthalmic Spatula

FDA UDI
KATENA PRODUCTS, INC.·00841668102268·SLOANE LASEK FLAP REPOSITOR

PENTAX VIDEO COLONOSCOPES (EC FAMILY)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

HEARTSTART ONSITE

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 6, 2014

ASR ACETABULAR CUPS 54

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·November 14, 2012

ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - CORK·Product code MCX·September 13, 2010

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·July 27, 2021

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·December 20, 2021

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·December 14, 2022

Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion

FDA Enforcement
Class II ·Terminated·Synthes (USA) Products LLC·September 2, 2015

Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion

FDA Enforcement
Class II ·Terminated·Synthes USA HQ, Inc.·November 6, 2013

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·October 27, 2021

Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.

FDA Enforcement
Class II ·Terminated·Synthes (USA) Products LLC·November 25, 2015

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·October 6, 2021

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·October 5, 2021

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·September 28, 2021

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·July 24, 2021

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·December 27, 2021

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·February 25, 2022