62 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Ultravision Visual Field Clearing System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ReLine
FDA UDI
Nuvasive, Inc.·00195377047182·RELINE-O Trial, 7mm H TP N L-pop
GoPLF! Posterior Lateral Fusion Device
FDA UDI
GetSet Surgical SA·07640387660157·GoPLF! Posterior Lateral Fusion Device, 5.5mm x...
OptumSI Implant System
FDA UDI
SI Solutions, LLC·00850057247138·Fixed 2 Pin Guide
NA
FDA UDI
Stryker GmbH·37613154126706·Screw Length Marker for 35mm
CorticaLINK MI
FDA UDI
LINKSPINE, INC.·00817329022978·5.0mm Cobalt Chrome Rod: 35mm Curved
OMNICARE DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
MODEL VISULAS 532S LASER WITH THE VITE OPTION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Widex
FDA UDI
Widex A/S·05706069424577·Widex MENU ME-19 BTE (Charcoalgrey ) Telecoil, ...
Widex
FDA UDI
Widex A/S·05706069370447·Widex mind220 M2-19 BTE (Charcoal grey ) Teleco...
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·OrganOx metra System
NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing System Spare Sterile Components 21-0001-99 Mapping Probe 21-0004-99 Indifferent Electrode 21-0007-99 Lead Tunneler Set 21-0009-99 Blue Cable Set 21-0010-99 Transducer Tubing 21-0017-99 PermaLoc Electrode 21-0023-99 Green Cable 21-0024-99 Orange Cable 21-0025-99 Yellow Cable 21-0026-99 White Cable 77-0050 Surgeon Instruction Manual 20-0045 NeuRx DPS System Kit, ALS HDE 20-0046 NeuRx Diaphragm Pacing System, Patient Kit, ALS Marketed under HDE H070003 as well as H100006
FDA Enforcement
Class III
·Terminated·Synapse Biomedical Inc·July 27, 2022
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·OrganOx metra System
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·OrganOx metra System
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·OrganOx metra® System
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·OrganOx metra® System
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·OrganOx metra® System
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·OrganOx metra System
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·OrganOx metra® System
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·OrganOx metra® System