7 results
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21ms
·
Sources: EU EUDAMED, US FDA
GATOR DRAPES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 15, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012
PUMP MMT-522NAL PRDGM INS V2.2 CL EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·August 17, 2010
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024