29 results · 23ms · Sources: EU EUDAMED, US FDA

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COOK URETERAL BALLOON DILATION CATHETER SET

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

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756001861·12 IN. KNEE BRACE

W & H ASSISTINA

FDA 510(k)
FDA Class 1 ·Dental

KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10

FDA 510(k)
FDA Class 2 ·Ophthalmic

ASR ACETABULAR CUPS 58

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·April 11, 2012

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 19, 2025

THORACIC GRASPER INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·November 6, 2013

ASR ACETABULAR CUPS 48

FDA Adverse Event
Injury ·DEPUY INTL, LTD.·Product code KWA·December 29, 2010

ALLEGRETTO WAVE EYE-Q

FDA Adverse Event
Injury ·WAVELIGHT GMBH·Product code LZS·April 3, 2013

VENTAK PRIZM

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 5, 2011

PFC SIGMA C/R NPOR FEM RT SZ 3

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, DEPUY-CORK DIVISION·Product code JWH·May 7, 2008

ASR UNI FEMORAL IMPL SIZE 51

FDA Adverse Event
Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·August 21, 2013

ASR ACETABULAR CUPS 60

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·October 24, 2015

ASR ACETABULAR CUPS 58

FDA Adverse Event
Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·August 21, 2013

ASR UNI FEMORAL IMPL SIZE 49

FDA Adverse Event
Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·July 22, 2013

ADAPTER SLEEVES 12/14 +8

FDA Adverse Event
Injury ·DEPUY INTL.,LTD 8010379·Product code KWA·November 4, 2015

ADAPTER SLEEVES

FDA Adverse Event
Injury ·DEPUY INTL.,LTD 8010379·Product code KWA·February 2, 2016

ASR ACETABULAR CUPS 56

FDA Adverse Event
Injury ·DEPUY INTL.,LTD 8010379·Product code KWA·February 2, 2016

ASR UNI FEMORAL IMPL SIZE 53

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·October 23, 2015

STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.

FDA Enforcement
Class II ·Terminated·Advanced Sterilization Products·May 8, 2013