17 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICON
FDA 510(k)
FDA Class 2
·Orthopedic
Nogama
FDA UDI
SILMET LTD·07290012207044·Dental Amalgam Capsules
JOBST Anti-Embolism
FDA UDI
BSN MEDICAL, INC.·00035664114725·ANTI-EMB STOCKINGS KNEE HIGH CLOSED TOE MEDIUM ...
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213033757·Coupling Treatment Tube for 5F Flexibles (12)
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089476343·
MULTIFIT TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 8, 2025
INTIMA-II Y 26GAX0.56IN MZPRN SLM NPVC
FDA Adverse Event
Malfunction
·Product code FPA·August 27, 2021
10ML STERILE LUER-LOCK SYRINGES
FDA Adverse Event
Malfunction
·BD·Product code FMF·May 8, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·September 23, 2014
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 13, 2011
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025