72 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Tissue Adhesive For Internal Use
FDA Pre-Market Approval
FDA Class 3
·COHERA MEDICAL TISSUEGLU SURGICAL ADHESIVE
Lymph Node Location System During Sentinel Biopsy Procedure
FDA Pre-Market Approval
FDA Class 3
·Magtrace® and Sentimag® Magnetic Locatization System (PUV)
Lymph Node Location System During Sentinel Biopsy Procedure
FDA Pre-Market Approval
FDA Class 3
·Magtrace and Sentimag Magnetic Locatization System (PUV)
Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)
FDA Pre-Market Approval
FDA Class 3
·Vysis CLL FISH Probe Kit
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 3
·BIOLECTRON ORTHO-PAK BONE GROWTH STIMULATOR/SPINALPAK SPINAL FUSION STIMULATOR
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·SVS APEX (FORMERLY OMNIMED) EXCIMER LASER SYSTEM FOR PHOTOREFRACTIVE KERATECTOMY (PRK)
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·VISX EXCIMER LASER SYSTEM MODELS B AND C FOR PHOTOREFRACTIVE KERATECTOMY (PRK)
SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301
FDA 510(k)
FDA Class 3
·Cardiovascular
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 3
·BIOMET ORTHOPAK NON INVASIVE BONE GROWTH STIMULATOR SYSTEM; SPINAL PAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·HiResolution Bionic Ear System
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·samaritan® PAD 350P (SAM 350P), samaritan® PAD 360P (SAM 360P), samaritan® PAD 450P (SAM 450P), Pad-Paks (Adult, Pediatr
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Cardinal Health Multifunctional Defibrillation Electrode