LIPID PROFILE

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

TOTAL LIPIDS REAGENT SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

VENTANA CEA PRIMARY ANTIBODY

FDA 510(k)

FDA Class 2 ·Immunology

PAP ANTIBODY KIT

FDA 510(k)

FDA Class 2 ·Immunology

Saliva, Artificial

FDA Pre-Market Approval

FDA Unclassified ·SALIVART

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·Rapid fFN Cassette Kit for the TLiIQ System, Rapid fFN Control for the TLiIQ System

DYNABITE HYSTEROSCOPIC FORCEPS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DYNABITE LAPAROSCOPIC FORCEPS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DYNABITE HOT GI BIOPSY FORCEPS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KYPHON® Bone Filler Device (BFD)

FDA UDI

MEDTRONIC SOFAMOR DANEK, INC.·00643169335868·BONE FILLER DEVICE F04B SIZE 3-RB

KYPHON® Bone Filler Device (BFD)

FDA UDI

MEDTRONIC SOFAMOR DANEK, INC.·00763000311650·BONE FILLER DEVICE F04B SIZE 3-RB

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·Rapid fFN for the TLiIQ System

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·Rapid fFN for the TLiIQ System

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·Rapid fFN for the TLiIQ System

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·Rapid fFN for the TLiIQ System

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·Rapid fFN for the TLiIQ System

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·RAPID FFN FOR THE TLIIQ SYSTEM

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·RAPID FFN FOR THE TLIIQ SYSTEM

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE DS & 2000D FFDM SYSTEM

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·Rapid fFN for the TLiIQ System