21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONVEY GUIDING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564030849·Linen Pack, Ortho
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306819766·St Mark's Deep Pelvic Retractor, Narrow 7" wit...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450194416·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450194423·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197412704·TC Heymann Nasal Scissors, blunt,
knee b...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197037402·TC Gorney Facelift Scissors
curved...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197037419·TC Gorney Facelift Scissors
curved...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197506649·TC RZ Gorney Facelift Scissors
curved...
MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900
FDA 510(k)
FDA Class 2
·Cardiovascular
ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IN00087 CLERMONT FERRAND PH
FDA Adverse Event
Death
·SORIN GROUP ITALIA·Product code DWF·March 7, 2014
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·January 7, 2016
SPIDERFX EMBOLIC PROTECTION 2. COMMON DEVICE NAME TEMPORARY CAROTID CATHETER FOR
FDA Adverse Event
Injury
·EV3 INC.·Product code NTE·May 20, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 10, 2011
LIFEPAK 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·August 12, 2008
BD CONNECTA¿ PLUS STOPCOCK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·November 16, 2021
INSPIRE 6F HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 21, 2022
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·June 8, 2016
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015