Jac-Cell Medic testers

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INSULATION AND CONTINUITY TESTER PLUS ACCESSORIES; MODELS ATI014 & ATI014 FC

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AUTONEB ACCESSORY CROSS (AAC)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Vertex Hip Fracture Nailing System

FDA 510(k)

FDA Class 2 ·Orthopedic

Solo+ Tympanostomy Tube Device (TTD)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Bone Cement-Normal Viscosity

FDA 510(k)

FDA Class 2 ·Orthopedic

BLUE MOUNTAIN CERVICAL PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

AYERS ROCK CERVICAL CAGE

FDA 510(k)

FDA Class 2 ·Orthopedic

PULSE-AID DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

TWIN PEAKS LUMBAR CAGE

FDA 510(k)

FDA Class 2 ·Orthopedic

MONT BLANC PEDICLE SCREW SYSTEMS

FDA 510(k)

FDA Class 2 ·Orthopedic

SENSUA!

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AWARE PAD

FDA 510(k)

FDA Class 2 ·Radiology

EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FREND PSA PLUS (REAGENT CARTRIDGE)

FDA 510(k)

FDA Class 2 ·Immunology

FREND TSH (REAGENT CARTRIDGE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BAK/CERVICAL (BAK/C) (R) INTERBODY FUSION SYSTEM

OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODEL 617 CARDIAC OUTPUT COMPUTER

FDA 510(k)

FDA Class 2 ·Cardiovascular