8 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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URETERAL DOUBLE PIGTAIL STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNILITH PULSE GENERATOR VVI #7542
FDA 510(k)
FDA Class 3
·Cardiovascular
SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GRASEBY 500 SYRINGE PUMP
FDA Adverse Event
Death
·SMITHS MEDICAL INTERNATIONAL LTD.·Product code FRN·May 15, 2014
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·November 15, 2012
SERIES 20000 LEGACY
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·September 10, 2010
GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024