EQ-PRC LC WARFARIN GENOTYPING KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

NEEDLE INCAPACITATOR (NEEDLE GUARD)

FDA 510(k)

FDA Class 2 ·General Hospital

LOMEFLOXACIN, 10 MCG, SENSI DISC

FDA 510(k)

FDA Class 2 ·Microbiology

CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

PACIFIC 56 (CB-40)

FDA 510(k)

FDA Class 2 ·Dental

BIOSPONGE RECONSTRUCTION DISCS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CADIMAS VERSION 1.0

FDA 510(k)

FDA Class 2 ·Radiology

WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER

FDA 510(k)

FDA Class 2 ·Cardiovascular

THROMBOMAX-HS WITH CALCIUM, MODEL T6540

FDA 510(k)

FDA Class 2 ·Hematology

VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin

FDA 510(k)

FDA Class 2 ·Microbiology

Q-TIPS, FAICHNEY, PRIVATE LABEL

FDA 510(k)

FDA Class 2 ·General Hospital

AUTOPAK 12 T3 RIA TEST DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFPODOXIME (GN) 0.125-8UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

TERUMO DISPOSABLE HYPODERMC SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)

FDA 510(k)

FDA Class 2 ·Anesthesiology

WONDFO MULTI-DRUG URINE TEST CUP, PANEL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CUSTODIOL HTK SOLUTION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology