Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV II IMMUNOASSAY.

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-ZYME ENZYMATIC CLEANER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CUTTING BALLOON ULTRA2 MONORAIL (MR) PTCA CATHETER (CUTTING BALLOON)

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·NORIAN SRS CEMENT

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·NORIAN SRS CEMENT

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·NORIAN SRS BONE CEMENT

MULTI-STIM TENS, AP-101081T

FDA 510(k)

FDA Class 2 ·Neurology

BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T

FDA 510(k)

FDA Class 2 ·Neurology

AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MODEL TS-140600

FDA 510(k)

FDA Class 2 ·Physical Medicine

APEX MEDICAL LCD TENS-VII

FDA 510(k)

FDA Class 2 ·Neurology

ACU-STIM TENS, AP-101082T

FDA 510(k)

FDA Class 2 ·Neurology

BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODIFICATION TO:APEX MEDICAL IF-4100

FDA 510(k)

FDA Class 2 ·Neurology

COM-PATCH

FDA 510(k)

FDA Class 2 ·Neurology

MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T

FDA 510(k)

FDA Class 2 ·Physical Medicine

Geonic Nasal Aspirator, Geonic Nasal Cleaner

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

APEX MEDICAL DIGITAL TENS TS1211, TS1212

FDA 510(k)

FDA Class 2 ·Neurology

APEX MEDICAL DIGITAL EMS TS1311, TS1312

FDA 510(k)

FDA Class 2 ·Physical Medicine

MICRO II MICROCURRENT TENS

FDA 510(k)

FDA Class 2 ·Neurology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETERS