131 results · 38ms · Sources: EU EUDAMED, US FDA

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·Axonics Sacral Neuromodulation System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·Axonics Sacral Neuromodulation System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·iSert® Pre-loaded System; IPURE Pre-loaded System; PreVue Pre-loaded System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·PreVue Pre-loaded System, IPURE Pre-loaded System

FDA Pre-Market Approval
TOUCH® CMC 1 Prosthesis

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·iSert® Pre-loaded System, iSert Preloaded IOL System, IPURE Pre-loaded System, PreVue Pre-loaded System

FDA Pre-Market Approval
PRE OP SPONGE

Susceptibility Test Powders, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·LINCOCIN SUSCEPTIBILITY PWD

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·PreVue Pre-Loaded System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·Axonics Sacral Neuromodulation (SNM) System for Bowel Control

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·Axonics Sacral Neuromodulation (SNM) System Urinary Control

Susceptibility Test Powders, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·STERILE CLEOCIN SUSCEPTIBILITY PWD (CLINDAMYCIN)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·COSEAL SURGICAL SEALANT (ORIGINAL AND PRE-MIXED)

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·R1S RAPID EXCHANGE PRE-DILATATION PTCA BALLOON CATHETER

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval
FDA Class 3 ·AAV5 DetectCDx®

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval
FDA Class 3 ·AAV5 DetectCDx

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AcrySof IQ Aspheric IOL with the UltraSert Pre-loaded Delivery System