LAB-TEK FTA-ABS KIT

FDA 510(k)

FDA Class 2 ·Microbiology

POLYCHACO FIA-ABS TEST FOR SYPHILIS

FDA 510(k)

FDA Class 2 ·Microbiology

ALTA LAG SCREW AND COMPRESSION SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

FULLY THREADED ALTA CANCELLOUS BONE SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

T/K (ATA/AMA) UNIVERSAL BIOPAK

FDA 510(k)

FDA Class 2 ·Immunology

Polyfusion IV Administration Sets

FDA 510(k)

FDA Class 2 ·General Hospital

PANPAC DISPOSABLE VACUUM CURETTES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ALTA FEMORAL INTRAMEDULLARY RODS/CFX RODS MODIFICATION

FDA 510(k)

FDA Class 2 ·Orthopedic

ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL PLATE SYS

FDA 510(k)

FDA Class 2 ·Orthopedic

STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS

FDA 510(k)

FDA Class 2 ·Radiology

ALTA SYSTEMS TIBIAL/UPPER EXTREMITY DIAPHYSEAL PLT

FDA 510(k)

FDA Class 2 ·Orthopedic

ALTA FEMORAL INTRAMEDULLARY ROD SYSTEM, ADD SIZES

FDA 510(k)

FDA Class 2 ·Orthopedic

ALTA DOME AND PLUNGER (MEC HIP BOLT)

FDA 510(k)

FDA Class 2 ·Orthopedic

REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RAPID IMF

FDA 510(k)

FDA Class 2 ·Dental

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ARMSTRONG STERILE SALINE SOLUTION

Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·ATA SOFTWARE CARTRIDGE (SWM 1000 I-KTB.0.U)

RI MSC (MIGRATION SEDIMENTATION CHAMBER)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology