13 results
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20ms
·
Sources: EU EUDAMED, US FDA
Cardinal Health Nitrile Examination Gloves Extended Cuff
FDA 510(k)
FDA Class 1
·General Hospital
COR
FDA UDI
DEPUY MITEK, LLC·10886705012497·Mitek COR Plunger 6mm, 5 - 25mm (Plus or Minus ...
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113301·STAB KNIFE 45 DEGREE (BX/5)
TMS SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036089191·
Medline ReNewal Reprocessed Endopath Endoscopic Instruments
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STIMUPLEX HNS-12, MODEL 4892098
FDA 510(k)
FDA Class 2
·Anesthesiology
NA
FDA UDI
Exactech, Inc.·10885862524164·TRIAL, TIBIAL INSERT, SPACER, SIZE 3, SIZE 3.5,...
BD LUER-LOK¿ TIP SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 17, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 9, 2025
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 17, 2011
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·November 14, 2014
URETEX SUPPORT PP KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·July 23, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025