Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·DISINTEGRATOR PRO NEEDLE DESTRUCTION DEVICE

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SODIUM CHLORIDE TABLETS, USP

TOMi Scope

FDA 510(k)

FDA Class 2 ·Radiology

OtoSight Middle Ear Scope

FDA 510(k)

FDA Class 2 ·Radiology

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·AL-47 SOFT CONTACT LENS

VM PACS WITH VM MEDICAL WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Revitalair 430F

FDA 510(k)

FDA Class 2 ·Anesthesiology

WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIO SPA INTELLIGENT

FDA 510(k)

FDA Class 2 ·Physical Medicine

Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)

FDA 510(k)

FDA Class 2 ·General Hospital

WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR.

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WIENER LAB GOT (AST) UV AA LIQUIDA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator

FDA 510(k)

FDA Class 2 ·General Hospital

WIENER LAB. ALP 405

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FAgamin®

FDA 510(k)

FDA Class 2 ·Dental

WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

WIENER LAB. CREATININA CINETICA AA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry