2,488 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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System, Laser, Fiber Optic, Photodynamic Therapy
FDA Pre-Market Approval
FDA Class 3
·OPTIGUIDE Fiber Optic Diffuser (pb 200, PB 700 Series)
Laparoscopic Contraceptive Tubal Occlusion Device
FDA Pre-Market Approval
FDA Class 3
·DISPOSABLE FALOPE-RING BAND APPLICATOR KITS
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·DuraSeal Exact Spine Sealant System
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·DuraSeal Dural Sealant System
Intraocular Pressure Lowering Implant
FDA Pre-Market Approval
FDA Class 3
·Hydrus® Microstent
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·MINIMED 530G SYSTEM
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·PARADIGM REAL-TIME REVEL SYSTEM
Gases Used Within Eye To Place Pressure On Detached Retina
FDA Pre-Market Approval
FDA Class 3
·UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy
Gases Used Within Eye To Place Pressure On Detached Retina
FDA Pre-Market Approval
FDA Class 3
·UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery
Prosthesis, Spinous Process Spacer/Plate
FDA Pre-Market Approval
FDA Class 3
·Superion® Indirect Decompression System
Filler, Bone Void, Synthetic Peptide
FDA Pre-Market Approval
FDA Class 3
·i-FACTOR Peptide Enhanced Bone Graft
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 3
·SPINALOGIC 1000 BONE GROWTH STIMULATOR
Stimulator, Invasive Bone Growth
FDA Pre-Market Approval
FDA Class 3
·EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR
Oximeter, Fetal Pulse
FDA Pre-Market Approval
FDA Class 3
·OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·EXOGEN 2000+ LOW INTENSITY FRACTURE HEALING SYSTEM
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·AFX VELA PROXIMAL ENDOGRAFT SYSTEM
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·EXOGEN 4000+BONE HEALING SYSTEM
Implant, Hearing, Active, Middle Ear, Partially Implanted
FDA Pre-Market Approval
FDA Class 3
·MAXUM SYSTEM
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
FDA Pre-Market Approval
FDA Class 3
·UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH
Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
FDA Pre-Market Approval
FDA Class 3
·EXOGEN 2000+