9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERCUSSOR
FDA 510(k)
FDA Class 2
·Anesthesiology
75V - UP Facilities
FDA UDI
Certified Safety Manufacturing, Inc.·00766588121666·75V - UP Facilities
ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BROWN)
FDA 510(k)
FDA Class 1
·General Hospital
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 15, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
DEXTRUS 4135
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·August 18, 2010
DEKA SMARTXIDE² TRIO
FDA Adverse Event
Malfunction
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 31, 2023
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024