411 results · 18ms · Sources: EU EUDAMED, US FDA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MULTI-PARTITION OPERATING ENVIRONMENT (MOE), VERSION 1.0

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ASSORTED MOD. C LOOPS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ASSORTED MOD. C LOOPS

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval
FDA Class 3 ·TELECTRONICS OSTEOSTIM BONW GROWTH STIMULATOR MODE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC(R) MODELS 9710/9710A ,MOD.2038 MODIFICAT

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval
FDA Class 3 ·DARDIK BIOGRAFT(R) MOD. HUMAN UMBILICAL VEIN GRAFT

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL P-17 MOD. C LOOP W/NOTCH POSTERIOR CHAMBER

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·SYMPHONY DR 2550 MODE AND ELAVIEW 1.28 UG1 PROGRAMMING SOFTWARE

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODES SI-18B AND SI-18NB ULTRAVIOLET ABSORBINGSILICONE POSTERIOR CHAMBER IOLS

Telescope, Implantable, Miniature

FDA Pre-Market Approval
FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE (IMT) MODES WIDE ANGLE 2.2X & WIDE ANGLE 2.7X

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval
FDA Class 3 ·PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·SCULPTRA, SCULPTRA AESTHETIC

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·BLOOD TUBING SYSTEM FOR THE LIPOSORBER LA-15 SYSTEM

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·FEMCARE FILSHIE CLIP SYSTEM

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·FLOSEAL MATRIX/PROCEED HEMOSTATIC SEALANTS

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·MENTOR™ MemoryGel™ Enhance Breast Implants

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval
FDA Class 3 ·T:SLIM G4TM INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·MENTOR™ MemoryGel™ Enhance Breast Implants

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ESSENTIO Models L100, L101, L121; PROPONENT Models L200, L201, L221; ACCOLADE Models L300, L301, L321; PROPONENT MRI Mod

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·Mater Water Vapor System - Model # GEA-SYS-16-0500, Mara Water Vapor Probe Kit - Model # DDK-16-050, Mara Console - Mode