16 results
·
34ms
·
Sources: EU EUDAMED, US FDA
DERMASTREAM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Pro-Flo™
FDA UDI
MEDTRONIC, INC.·00613994944559·CATH 060046 PF 10PK 6F SF TP AL III 100
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190844·A/P Cutting Block Assy, Open Style Size 6
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306801297·Tissue Forceps, 1x2, Smooth, 16 cm
Medallion®
FDA UDI
Merit Medical Systems, Inc.·00884450054406·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100460·ASSEMBLY, CADDIE, CURVED RODS WITH STOPS
KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)
FDA 510(k)
FDA Class 2
·Orthopedic
NUVOLASE 532 MEDICAL LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEXGEN LPS-FLEX FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code NJL·April 11, 2013
COAGUCHEK XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·June 12, 2008
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 15, 2011
NON-VENTED HOSPITAL FULL FACE MASK
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code MNT·April 26, 2017
UNKNOWN
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code GCJ·June 8, 2018
URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include: Gastro-intestinal examination Urography Bronchography Arthrography Hysterography Myelography Lymphography Skeletal radiography Tomography Venography/phlebography Special procedures that require subtracted and non-subtracted digital imaginginclude: Angiography Peripheral angiography (bolus chasing) Vascular and non-vascular interventional procedures.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·April 3, 2019
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