8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GASTROINTESTINAL SHEATH BRUSH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEARING AID, #UE7-D
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
PRESSURE MONITOR & CONTROL UNIT APC-02A
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GIA 60-3.8 SINGLE USE RELOADABLE STAPLER
FDA Adverse Event
Death
·COVIDIEN, FORMERLY USSC PUERTO RICO, INC.·Product code GDW·May 19, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 15, 2012
ACCURUS 800CS
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