29 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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