PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch

FDA 510(k)

FDA Class 2 ·Cardiovascular

CADIMPLANT

FDA 510(k)

FDA Class 2 ·Radiology

YAG MIR II LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Videa Perio Assist

FDA 510(k)

FDA Class 2 ·Radiology

iLet® Dosing Decision Software

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIOPSY FORCEPS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEVION S250i Proton Beam Radiation Therapy Device

FDA 510(k)

FDA Class 2 ·Radiology

DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MODIFIED PERIPHERAL DILATATION CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

BONE LAVAGE SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

Reprocessed Steerable Introducer

FDA 510(k)

FDA Class 2 ·Cardiovascular

VITATRACE

FDA 510(k)

FDA Class 2 ·Cardiovascular

AIR BLOCK

FDA 510(k)

FDA Class 2 ·Dental

CARA

FDA 510(k)

FDA Class 2 ·Radiology

Cordera Hip System

FDA 510(k)

FDA Class 2 ·Orthopedic

NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (36CM),

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator™ HD Ureteral Access Sheath Set 13/15 F x 28cm (M006

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CURITY THORACENTESIS TRAY

FDA 510(k)

FDA Class 2 ·General Hospital

SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular