12 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SALMAN SINUS BUTTON
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Pinnacle
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730010988·Pinnacle .022 R UL 4/5 -7T 0A 2DO (10PK)
Pinnacle®
FDA UDI
Ortho Organizers, Inc.·00190707112929·Pinnacle .022 R UL 4/5 -7T 0A 2DO (10PK)
Votion®
FDA UDI
Ortho Organizers, Inc.·00190707114855·Votion .022 R UL 4/5 -7T 0A 2DO (10PK) VOTION
Votion
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730009159·Votion .022 R UL 4/5 -7T 0A 2DO (10PK)
Electrocardiograph: SE-1200 Pro and SE-1201 Pro
FDA 510(k)
FDA Class 2
·Cardiovascular
SMITH & NEPHEW HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FLOGARD
FDA Adverse Event
Malfunction
·SHARP CORPORATION OSAKA JAPAN·Product code FRN·January 18, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·July 9, 2014
BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·October 2, 2013
Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class I
·Terminated·Covidien·February 11, 2015