12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURGISEAL TOPICAL SKIN ADHESIVE/SURGISEAL STYLUS TOPICAL SKIN ADHESIVE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PRINCETON
FDA UDI
Princeton Medical Group, Inc.·00810158219106·LAMINA SPREADER INGE 6MM WITH TEETH 6.75"
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319740736·Peers Towel Clamp 5-5/8" (14.4cm), non-perforating
SKINNER FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896023963·SKINNER FORCEPS WITH TUNGSTEN CARBIDE SERRATED ...
TENDERWET ACTIVE
FDA 510(k)
FDA Unclassified
·Unknown
INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ABS 2-0 GR 18 GS-21
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·December 1, 2015
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 3, 2014
LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·May 31, 2013
MEDTRONIC EDM LUMBAR CATHETER, CLOSED TIP, BARIUM IMPREGNATED, 80
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code JXG·June 21, 2011
Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port is a disposable medical device intended for use on patients requiring temporary augmentation of ventilation with or without supplemental oxygen delivery during episodes of acute ventilatory failure or insufficiency.
FDA Enforcement
Class I
·Terminated·Teleflex Medical·July 1, 2015
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019