COMPLETE CPR KIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

CLYDE CORONARY GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

AIRCAST VENAFLOW ELITE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

OC-Light S FIT

FDA 510(k)

FDA Class 2 ·Hematology

HANNIBAL GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OP-3 (TM) RGP CONTACT LENS

ORMCO SYSTEM 1+ (TM)

FDA 510(k)

FDA Class 2 ·Dental

S/2(TM) STOPCOCK

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SAFE-1(TM) SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

VIDAS NEPHROCHECK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ETEST Fosfomycin (FO) (0.032-512 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST

TECHNICON DPA-1(TM) SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

TECHNICON CHEM 1(TM) SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

TECHNICON H*2(TM) SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

OTT INSUFFLATION FILTER TUBING

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BOOSTER LITE 3 MOTORIZED SCOOTER

FDA 510(k)

FDA Class 2 ·Physical Medicine

MODIFIED TECHNICON DPA-1(TM) SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

TECHNICON DPA-1 (TM) CRP METHOD

FDA 510(k)

FDA Class 2 ·Immunology