62 results · 20ms · Sources: EU EUDAMED, 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