BSM 2000 DIALYSIS MACHINE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Accessories, Blood Circuit, Hemodialysis

FDA classification

FDA Class 2 ·Accessories, Blood Circuit, Hemodialysis

ABUSIGN(TM) COC, DOA-COC, ACCUSIGN(TM) COC, DOA-COC, DIOSIGN(TM) COC, DOA-COC

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BILIBLANKET PLUS PHOTOTHERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

COATEST(R) APC(TM) RESISTANCE

FDA 510(k)

FDA Class 2 ·Hematology

ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SENTINEL LITHIUM ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Lp(a) Ultra

FDA 510(k)

FDA Class 2 ·Immunology

TAKY-SPIKE PLUS

FDA 510(k)

FDA Class 2 ·General Hospital

FOX MOBILE

FDA 510(k)

FDA Class 2 ·Anesthesiology

Albumin BCP

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO SENTINEL CLIN CHEM CAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Volumat Polyethylene I.V. Administration Set

FDA 510(k)

FDA Class 2 ·General Hospital