8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Med-link Pulse Oximeter
FDA 510(k)
FDA Class 2
·Cardiovascular
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704514667·SIMS CURETTE SIZE 3 SHARP
WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TINNITUS THERAPY SYSTEM ANM T30 CR
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CONTOUR TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·October 20, 2008
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 16, 2011
GORE TEX VASCULAR GRAFT
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DSY·July 2, 2013
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026