8 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ECAT VISION PET SCANNER, MODELS 3000 & 5000
FDA 510(k)
FDA Class 2
·Radiology
LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 & LHCEK0000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·Product code FRN·April 29, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 9, 2011
ONE TOUCH BASIC ENAHANCED METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·July 22, 2008
Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026