INTIMAX(TM) IRRIGATION CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SpyGlass Discover Balloon Dilation Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Fusion Quattro Extraction Balloon

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CATHETER WITH INTRODUCER AND SYRINGES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Tri-Ex Extraction Balloon With Multiple Sizing

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE DS & 2000D FFDM SYSTEM

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE ESSENTIAL SYSTEM

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HEPATITIS C CHECK TESTING SERVICE

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·DERMABOND (A FORMULATION OF 2-OCTYL CYANOACRYLATE)

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·INDERMIL TISSUE ADHESIVE

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·HIGH VISCOSITY DERMABOND TOPICAL SKIN ADHESIVE

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish

FDA classification

FDA Class 2 ·Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish