HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE

FDA 510(k)

FDA Class 2 ·Cardiovascular

KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

GLENOID RESURFACING COMPONENT-3M-10816

FDA 510(k)

FDA Class 2 ·Orthopedic

Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H

FDA 510(k)

FDA Class 2 ·Cardiovascular

A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRILLIUM BIOPUMP PLUS, MODEL BPX80T

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TERUMO ROCSAFE HYBRID PERFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

BABY QUASAR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AB-180 XC SYSTEM, MODEL AB-180XC

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOVENTION CORX SYSTEM, MODEL FG 0001

FDA 510(k)

FDA Class 2 ·Cardiovascular

Comprehensive Segmental Revision System(SRS)

FDA 510(k)

FDA Class 2 ·Orthopedic

Catalyst CSR 3 Peg Glenoids

FDA 510(k)

FDA Class 2 ·Orthopedic

AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF

FDA 510(k)

FDA Class 2 ·Cardiovascular

TANDEMHEART PUMP

FDA 510(k)

FDA Class 2 ·Cardiovascular

ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP

FDA 510(k)

FDA Class 2 ·Cardiovascular

AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CHEMTAB

FDA 510(k)

FDA Class 2 ·Clinical Chemistry