CRITIC-ARS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)

FDA 510(k)

FDA Class 2 ·Orthopedic

Fix2Lock(PEEK Self Punching)

FDA 510(k)

FDA Class 2 ·Orthopedic

DIMENSION-WBG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Fix2Lock (PEEK Self Punching)

FDA 510(k)

FDA Class 2 ·Orthopedic

PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

DEPUY CERAMIC FEMORAL HEADS

FDA 510(k)

FDA Class 2 ·Orthopedic

Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)

FDA 510(k)

FDA Class 2 ·Orthopedic

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM (HUAM)

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.

ACCUHEART ELECTRODE BELT

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFIED OLSEN 755/756 SWITCHPENS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ALDOCTK-125

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALDOSTERONE RADIOIMMUNOASSAY TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EMC MODEL NO. STATOME 900

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BICEPS ELECTROCAUTERY SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ABC HANDPIECE ADAPTER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery