12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HD GUIDE CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SLENDERTONE FLEX, MODEL, 512
FDA 510(k)
FDA Class 2
·Physical Medicine
MALLORY-HEAD MODULAR CALCAR TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VERTECEM V+ CEMENT KIT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code NDN·March 28, 2013
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 17, 2024
VERTECEM V+ CEMENT KIT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code NDN·February 27, 2013
VERTECEM V+ CEMENT KIT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code NDN·March 1, 2013
VERTECEM V+ CEMENT KIT
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NDN·February 27, 2013
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·May 2, 2013
ENDURANT II
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·September 15, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 16, 2011
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024