1,184 results · 29ms · Sources: EU EUDAMED, US FDA

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·PLATINUM SOUND PROCESSOR (COCHLEAR IMPLANT)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·BTE (BEHIND-THE-EAR) SYSTEM SENSOR (ADULT)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CLARION MULTI-STRATEGY COCHLEAR IMPLANT(ADULT)

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED EMDOMETRIAL ABLATION SYSTEM

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·GLAUKOS ISTENT TRABECULAR MICRO BYPASS STENT SYSTEM

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·GYNECARE INTERCEED Absorbable Adhesion Barrier

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·NAVISTAR DS AND CELSIUS DS DIAGNOSTIC/ABLATION CATHETERS

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·GYNECARE INTERCEED™ Absorbable Adhesion Barrier

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·SURGICEL™ ORIGINAL Absorbable Hemostat, SURGICEL™ Nu-Knit Absorbable Hemostat, SURGICEL™ Fibrillar Absorbable Hemostat,

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·M6-C Artificial Cervical Disc

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·SMARTFREEZETM Catheter Extension Cable

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartStart FR3 Primary Battery (989803150161)

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Bellafill Dermal Filler

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·CERVISTA HPV 16/18 TEST

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·CERVISTA HPV HR TEST

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Precision Spinal Cord Stimulator (SCS) System- (Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval
FDA Class 3 ·Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) Systems

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·SURGICEL BRAND ABSORBABLE HEMOSTAT

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·E P TECH EPT-1000 CARDIAC ABLATION SYSTEM

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·SURGICEL® Absorbable Hemostats (SURGICEL® ORIGINAL, SURGICEL® NU-KNIT™ , SURGICEL® FIBRILLAR™, SURGICEL® SNOW™)