SURGICAL OSCILLATING SAW

FDA 510(k)

FDA Class 2 ·Dental

ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS

FDA 510(k)

FDA Class 2 ·Dental

DENTATUS OSCIOMAT

FDA 510(k)

FDA Class 2 ·Dental

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER M1000 SYSTEM

Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE)

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FOLEY CATHETER TRAY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HEALTH-PAK/WYCOMBE CSR WRAP

FDA 510(k)

FDA Class 2 ·General Hospital

HEPARIN LOCK FLUSH SOLUTION USP KIT,100

FDA 510(k)

FDA Class 2 ·General Hospital

KIT PAK IRRIGATION TRAY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CORDIPAK CARDIAC CATHETERIZATION PACK

FDA 510(k)

FDA Class 2 ·Cardiovascular

SKIN SCRUB KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FOLEY INSERTION TRAY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HEPARIN LOCK FLUSH PROCEDURE PACK

FDA 510(k)

FDA Class 2 ·General Hospital

HEPARIN LOCK FLUSH SOLUTION USP KIT

FDA 510(k)

FDA Class 2 ·General Hospital

NON-STERILE & STERILE DISPOSABLE SURGICAL DRAPES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FIRM MASTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

FDA 510(k)

FDA Class 2 ·Radiology

TRACH TAPE

FDA 510(k)

FDA Class 2 ·Anesthesiology

KIT PAK URINARY CARE SUPPLIES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology