20 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOGRAPH 6
FDA 510(k)
FDA Class 2
·Radiology
Molift
FDA UDI
Etac A/S·05707995001856·
CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 60mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665020779·
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 35 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955933028·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 35 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955934247·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 35 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955933639·Percutaneous Transluminal Angioplasty Balloon C...
Canaveral®
FDA UDI
FLOSPINE LLC·B183120600600·6.0mm Curved Rod, Ti Alloy 60mm
Persona® PPS®
FDA UDI
Zimmer, Inc.·00889024631526·
Persona® PPS®
FDA UDI
Zimmer, Inc.·00889024631519·
GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RITA STARBURST XLI ELECTROSURGICAL DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 21, 2026
BAR EXTENSION
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·March 19, 2019
BAR EXTENSION
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·March 19, 2019
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 19, 2013
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 15, 2011
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS CORP.·Product code LFR·June 12, 2008
PALLAS M/MAXIMIS 60mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
FDA Enforcement
Class II
·Terminated·Valorem Surgical LLC·August 16, 2017
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018