14 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WILSON COOK WIRE GUIDE AND PROTECTIVE GUIDE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PASS LP SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300
FDA 510(k)
FDA Class 2
·Cardiovascular
CONVEEN COUNTOUR, 800 ML, 65 CM TUBE
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code FAQ·November 30, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 11, 2013
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 2, 2014
GMK-SPHERE 02.12.0005L FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 7, 2021
USS-II NUT TAN GREEN
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code NKB·June 21, 2017
GALAXY G3 MINI 2MM X 3CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·May 18, 2022
CASH 14 PLAT COIL 4MMX6CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·May 18, 2022
GALAXY G3 MINI 2MM X 3CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·May 18, 2022
TI POLYAXIAL HEAD FOR USS POLYAXIAL
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code NKB·May 2, 2017
GALAXY G3 MINI 3MM X 6CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·May 18, 2022
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021