VIVIX-S

FDA 510(k)

FDA Class 2 ·Radiology

TERASON T3200 ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Optilume® Urethral Drug Coated Balloon

FDA registration

UROTRONIC INC·1 product·🇺🇸 United States

Isomedix Operations, Inc.

FDA registration

Isomedix Operations, Inc.·1 product·🇺🇸 United States

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval

FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval

FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval

FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval

FDA Class 3 ·Optilume Urethral Drug Coated Balloon catheter

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval

FDA Class 3 ·Optilume Urethral Drug Coated Balloon Catheter

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval

FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval

FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval

FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval

FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Mask, Surgical

FDA classification

FDA Class 2 ·Mask, Surgical

Catheter, Balloon, Urethral, Drug-Coated

FDA classification

FDA Class 3 ·Catheter, Balloon, Urethral, Drug-Coated

CSM part #s: C210-006, C210-005, C210-018, C210-009, C220-028, C220-036, C220-041

FDA registration

MIDWEST STERILIZATION CORP.·1 product·🇺🇸 United States

Solid State X-Ray Imager (Flat Panel/Digital Imager)

FDA classification

FDA Class 2 ·Solid State X-Ray Imager (Flat Panel/Digital Imager)

Transducer, Ultrasonic, Diagnostic

FDA classification

FDA Class 2 ·Transducer, Ultrasonic, Diagnostic