LAPAROSCOPIC CHOLANGIOCATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FUSION QUATTRO EXTRACTION BALLOON XL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

METICULY Patient-specific titanium maxillofacial mesh implant

FDA 510(k)

FDA Class 2 ·Dental

Oregon Scientific

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheter, Intracardiac Mapping, High-Density Array

FDA classification

FDA Class 2 ·Catheter, Intracardiac Mapping, High-Density Array

Catheter, Intracardiac Mapping, High-Density, Reprocessed

FDA classification

FDA Class 2 ·Catheter, Intracardiac Mapping, High-Density, Reprocessed

Complement C3b Activator, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Complement C3b Activator, Antigen, Antiserum, Control

Apparatus, Autotransfusion

FDA classification

FDA Class 2 ·Apparatus, Autotransfusion

Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

FDA classification

FDA Class 2 ·Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

Syringe, Balloon Inflation, Exempt

FDA classification

FDA Class 2 ·Syringe, Balloon Inflation, Exempt

Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

FDA classification

FDA Class 2 ·Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval

FDA Class 2 ·LITTON TRANSCUTANEOUS CO2 SYSTEM

Suture, Nonabsorbable, Synthetic, Polyamide

FDA Pre-Market Approval

FDA Class 2 ·NONABSORBABLE SURG. SUTURES, NYLON

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·TECHNOMED INTERNATIONAL SONOLITH 2000

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·DEKLENE(TM)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BOSTON LENS(R) CLEANER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BOSTON LENS(R) CLEANER

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·TRIPTER-X1 SERIES SHOCKWAVE LITHOTRIPTERS