SERIM DISINTEK GTA 2.1%, MODEL: 5164

FDA 510(k)

FDA Class 2 ·General Hospital

SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171

FDA 510(k)

FDA Class 2 ·General Hospital

ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)

FDA 510(k)

FDA Class 2 ·Microbiology

BARD AND BTA TEST

FDA 510(k)

FDA Class 2 ·Immunology

BARD BTA TRAK TEST

FDA 510(k)

FDA Class 2 ·Immunology

Blood Transfer Accessory (BTA)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ATA HCM MONOPLACE HYPERBARIC SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

NUVENTUS NV.C™ Surgical Cassette and Tray

FDA 510(k)

FDA Class 2 ·General Hospital

NUVENTUS NV.C™ Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

BTA STAT TEST PRESCRIPTION HOME USE

FDA 510(k)

FDA Class 2 ·Immunology

T/K (ATA/AMA) UNIVERSAL BIOPAK

FDA 510(k)

FDA Class 2 ·Immunology

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

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

PANPAC DISPOSABLE VACUUM CURETTES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

XENX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIRECT LDL/HDL CHOLESTEROL CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

RI MSC (MIGRATION SEDIMENTATION CHAMBER)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

E1000 Dx Digital Pathology Solution

FDA 510(k)

FDA Class 2 ·Pathology

SATURN ACTIVE LASER SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology