13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vscan Air
FDA 510(k)
FDA Class 2
·Radiology
BD BBL™ Sensi-Disc™ Kanamycin 30 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902313015·BD BBL™ Sensi-Disc™ Kanamycin 30 µg
OsteoMed
FDA UDI
OSTEOMED LLC·00845694036665·.062 X 2.5 K-Wire Phalanx Reamer Guide Pin
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573021536·INTRG WHISP MBT CEN +17T +4A 022 UR
OsteoMed
FDA UDI
OSTEOMED LLC·00845694076562·FPS .062 X 2.5" K-WIRE Sterile Qty 2
ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BD FACS SAMPLE PREP ASSISTANT III
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TENDRIL STS
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·November 6, 2014
LIGASURE IMPACT
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·July 25, 2011
XIENCE XPEDITION SV RX
FDA Adverse Event
Injury
·ABBOTT VASCULAR DEVICES·Product code MAF·July 11, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025