26 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
MAXCUT CARBIDE BUR (10/pk) FG 37
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811113571·MAXCUT CARBIDE BUR (10/pk) Shape: Inverted Cone...
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089430871·
Summa Orthopaedics System Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089466122·
HEISENBERG DYEING LIQUIDS
FDA 510(k)
FDA Class 2
·Dental
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES
FDA 510(k)
FDA Class 2
·Ophthalmic
BD FACSLYRIC¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·January 20, 2022
MONOSYN VIOLET 5/0 (1) 70CM HR17 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·May 9, 2013
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code MCX·September 23, 2014
ZOOM CRITICAL CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 18, 2011
BD ANGIOCATH¿ PLUS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·November 6, 2017
MONOSYN VIOLET 6/0 (0.7) 70CM HR13 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019
BD ANGIOCATH¿ PLUS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·November 10, 2017
BD ANGIOCATH¿ PLUS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·November 6, 2017
BD ANGIOCATH PLUS CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·November 6, 2017
BD ANGIOCATH¿ PLUS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·November 10, 2017
PREMILENE 3/0 (2) 75CM DS24 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAW·December 11, 2019
MONOSYN VIOLET 5/0 (1) 70CM HR17 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·December 11, 2019
Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013