2,283 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Aspiration Therapy System
FDA Pre-Market Approval
FDA Class 3
·AspireAssist
Implanted Diaphragmatic/Phrenic Nerve Stimulator
FDA Pre-Market Approval
FDA Class 3
·DIAPHRAGMATIC PACEMAKER PHRENIC NERVE
Wearable Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·LIFEVEST WEARABLE DEFIBRILLATOR
System, Test, Tumor Marker, For Detection Of Bladder Cancer
FDA Pre-Market Approval
FDA Class 3
·ALERE NMP22 URINE COLLECTION KIT
CONSENSUS(TM) TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 3
·Orthopedic
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Sequentia LT INS (Model 977005), Vanta INS with AdaptiveStim (Model 977006)
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·Percept PC INS with BrainSense (Model B35200)
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·DIGENE HYBRID CAPTURE 2 HPV DNA TEST
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 3
·PHYSIO-STIM BONE GROWTH STIMULATOR
KODAK T-MAT C FILM SO-119
FDA 510(k)
FDA Class 3
·Unknown
KODAK T-MAT H FILM SO-118
FDA 510(k)
FDA Class 3
·Unknown
P.F.C. APICAL PLUG
FDA 510(k)
FDA Class 3
·Orthopedic
JOINT MEASUREMENT INDICATOR
FDA 510(k)
FDA Class 3
·Orthopedic
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·THORATEC VENTRICULAR ASIST DEVICE
GRAPHIC STRESS TELETHERMOMETRY
FDA 510(k)
FDA Class 3
·Obstetrics/Gynecology
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·VISTAKON (senofilcon A) Brand Contact Lenses
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·VISTAKON (SENOFILCON A) BRAND CONTACT LENSES
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·VISTAKON (senofilcon A) Brand Contact Lenses
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·VISTAKON (SENOFILCON A) BRAND CONTACT LENSES