HKT Anatomical Locking Trauma System

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO VIEWSEND MEDICAL

FDA 510(k)

FDA Class 2 ·Radiology

DELFIA DIGOXIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ORTHO-MUNE 0KT 11 (CD2) MONOCLONAL ANTIBODY (MURINE)

FDA 510(k)

FDA Class 2 ·Hematology

THE EMIT 2000 TACROLIMUS CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

iStim S2 OTC Pain Relief TENS

FDA 510(k)

FDA Class 2 ·Neurology

DigitalDiagnost C50

FDA 510(k)

FDA Class 2 ·Radiology

Balego TENS Digital Edition with Accessories for Pain Relief (OTC)

FDA 510(k)

FDA Class 2 ·Neurology

QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN ANTI-LKM-1 ELISA(LGG)

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE LKM-1 ELISA

FDA 510(k)

FDA Class 2 ·Immunology

Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·HYPERION LTK SYSTEM

Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·HYPERION LTK SYSTEM

ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

D-3160 SORBENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BLOOD CELL PROCESSOR MODEL 2 IBM 2991

FDA 510(k)

FDA Class 2 ·Hematology

REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

REDY 2000

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BLOOD CELL SEPARATOR 2997

FDA 510(k)

FDA Class 2 ·Hematology

2008 HEMODIALYSIS SORBENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology