15 results
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20ms
·
Sources: EU EUDAMED, US FDA
Water-based Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776183110·Hibbs Osteotome . Str
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780188100·Integra® Jarit® Hibbs Osteotome, 9-1/2", Straig...
SCANLAN® Clamp
FDA UDI
SCANLAN INTERNATIONAL INC·00846159013191·Kitzmiller Clamp Right Angled 8" / 20 cm
Delta®
FDA UDI
MEDTRONIC PS MEDICAL, INC.·00613994965844·SHUNT 25014-2 UNIT DELTA SML PERIT 90
Stainless Steel Archwire
FDA UDI
Ortho Arch Company Inc·D90925014211·.018 UPPER SS RIGHT FORM ARCHWIRES (50)
Delta®
FDA UDI
MEDTRONIC PS MEDICAL, INC.·00643169472914·SHUNT 25014-2 UNIT DELTA SML PERIT 90
Hohmann Lever – Curved – Narrow
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215076702·
RESMED MERIDIAN MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
Single Use Balloon Dilator V (with Knife)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FLOGARD
FDA Adverse Event
Malfunction
·SHARP CORPORATION OSAKA JAPAN·Product code FRN·November 14, 2014
DEPUY ASR XL FEM IMP SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 15, 2011
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 23, 2013
Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general radiology applications with or without contract injection and interventional procedures.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 19, 2019
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·October 13, 2021