13 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MAYO STILLE SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896095816·MAYO STILLE SCISSORS CURVED ROUND TUNGSTEN CARB...
SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
INTRAORAL BELSENSOR GOLD
FDA 510(k)
FDA Class 2
·Dental
ACCU-CHEK ® ULTRAFLEX INFUSION SET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 14, 2013
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014
LIGAMAX- CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 3, 2011
HEAL COLLAR 3.5X4.5, 5MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code NHA·August 14, 2017
HEAL COLLAR 3.5X4.5, 3MM
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code NHA·August 10, 2017
HEAL COLLAR 3.5X3.5, 5MM
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code NHA·July 18, 2017
BD SOLOSHOT SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·October 14, 2022
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