H-H HUNTER ACTIVE TENDON IMPLANT BC

FDA 510(k)

FDA Class 2 ·Orthopedic

PASSIVE TENDON IMPLANT

FDA 510(k)

FDA Class 2 ·Orthopedic

H-H HUNTER ACTIVE TENDON IMPLANT PC

FDA 510(k)

FDA Class 2 ·Orthopedic

H-H HUNTER ACTIVE TENDON IMPLANT

FDA 510(k)

FDA Class 2 ·Orthopedic

Universal Tendon Spacer

FDA 510(k)

FDA Class 2 ·Orthopedic

ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS

FDA 510(k)

FDA Class 2 ·Radiology

MODEL EB-22 NOISE STIK

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ARMSTRONG STERILE SALINE SOLUTION

TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS

FDA 510(k)

FDA Class 2 ·Radiology

HemosIL Liquid Anti-Xa

FDA 510(k)

FDA Class 2 ·Hematology

INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)

FDA 510(k)

FDA Class 2 ·Hematology

HemosIL Liquid Anti-Xa

FDA 510(k)

FDA Class 2 ·Hematology

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE TEST KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE TEST KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE TEST KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE TEST KIT

DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA

FDA 510(k)

FDA Class 2 ·Immunology

ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads

FDA 510(k)

FDA Class 2 ·Orthopedic