BGM GALECTIN -3

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Single Use Arthroscopic Electrode (with Pencil)

FDA 510(k)

FDA Class 2 ·Orthopedic

Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr 5.0mm (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024); Curved Standard Ball Burr XL, 5.0mm (R-10025); Curved Shaver XL 4.2mm (R-10026); Curved Dynablator, XL (R-10027)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LOW IONIC STRENGTH SOLUTION (LISS)

FDA 510(k)

FDA Class 2 ·Hematology

TAS ANALYZER, MODEL 1009

FDA 510(k)

FDA Class 2 ·Hematology

BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2

FDA 510(k)

FDA Class 2 ·Hematology

CITREX III

FDA 510(k)

FDA Class 2 ·Hematology

BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2

FDA 510(k)

FDA Class 2 ·Hematology

TEG 6s Hemostasis System

FDA 510(k)

FDA Class 2 ·Hematology

CASCASE 480 SNSLYZER

FDA 510(k)

FDA Class 2 ·Hematology

AMAX CS-190 COAGULATION ANALYZER SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

IL TEST 84673-30 CHROMOGENICS CONTROL PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)

FDA 510(k)

FDA Class 2 ·Hematology

STA COMPACT MAX

FDA 510(k)

FDA Class 2 ·Hematology

MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP

FDA 510(k)

FDA Class 2 ·Hematology

ELVI 818 DIGICLOT MULTISCAN

FDA 510(k)

FDA Class 2 ·Hematology

PT HEPARIN ADSORBENT

FDA 510(k)

FDA Class 2 ·Hematology