26 results · 22ms · Sources: EU EUDAMED, 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