PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA

FDA 510(k)

FDA Class 2 ·Microbiology

ACCUPROBE HAEOMPHILUS INFLUENZAE CULTURE

FDA 510(k)

FDA Class 2 ·Microbiology

SAS BRUCELLAS ABORTUS ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

LEPTOSPIROSIS IHA

FDA 510(k)

FDA Class 2 ·Microbiology

BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX

FDA 510(k)

FDA Class 2 ·Microbiology

ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology

FDA 510(k)

FDA Class 2 ·Orthopedic

ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology

FDA 510(k)

FDA Class 2 ·Orthopedic

ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology

FDA 510(k)

FDA Class 2 ·Orthopedic

CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP

FDA 510(k)

FDA Class 2 ·Cardiovascular

T3 RIA (PEG) DIAGNOSTIC KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION

FDA 510(k)

FDA Class 2 ·Cardiovascular

RABBIT ANTIBODY TO HUMAN T3

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TRIIODOTHYRONINE RIA SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

10.5 FRENCH PERCUTANEOUS DOUBLE LUMEN INTRA-AORTIC

FDA 510(k)

FDA Class 2 ·Cardiovascular

PERCUTANEOUS INTRA-AORTIC BALLOON CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMMULITE FREE T3

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

THYROXINE (T4) 125I

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO

FDA 510(k)

FDA Class 2 ·Cardiovascular

PHASE II T3 RADIOIMMUNOASSAY KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry