10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814183·GENUMEDI PT SILVER L I
COLONIC SPLINTING OVERTUBE, MODEL 00711145
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EUROIMMUN ANTI-SLA/LP ELISA(LGG)
FDA 510(k)
FDA Class 2
·Immunology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code QFG·August 16, 2023
ZEPHYR XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·January 13, 2014
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 20, 2013
CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·August 4, 2011
TRUEMETRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·July 10, 2017
AV FISTULA PACK- (1) DRAPE T LAPAROT 102" X 78" X121 " STD SMS (3) GOWN SURG. REINFORCED X-LARGE EXTRA LONG LEVEL IV (1) DRAPE SHEET 42" X 57" SMS (4) DRAPE UTILITY WITH TAPE LIF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1) PENCIL CAUTERY HAND SWITCHING LIF (1) TUBE SUCTION CONNECT "Y-1" X 12' LIF (1) FRAZIER WITH CONTROL VENT & OBTUR 10F LIF (2) LITE GLOVE LIF (1) BOWL UTILITY 32oz LIF (2) BOWL UTILITY 16oz LIF (10) LAP SPONGE PREWASH XRD LIF (1) SOLUTION SURGICAL DURAPREP 26ML LIF (3) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF (1) SYRINGE 30CC WITHOUT NEEDLE LUER LOCK UF (1) SYRINGE 5CC WITH NEEDLE 21G X 1% LUER LOCK UF (2) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK UF (1) NEEDLE HYPODERMIC 18G X 1 % (2) COUNTER NEEDLE & BLADE 10C MAG/CLEAR UF (1) COVER MAYO STAND REINFORCED LIF (1) COVER TABLE 44" X 90" (1) MAYO TRAY SMALL (2) ABSORBENT TOWEL 15" X 20" UF (1) BOWL WITH LID PLASTIC 80oz EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014