MCR4000 & MCR4000F CARDIOTOMY RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MINIMAX(R)/MAXIMA(R) HOLLOW FIBER OXYGENATORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Embosphere Microspheres

FDA 510(k)

FDA Class 2 ·Cardiovascular

Fas Aligner System

FDA 510(k)

FDA Class 2 ·Dental

DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D

FDA 510(k)

FDA Class 2 ·Ophthalmic

Newclip Patient-matched instrumentation non sterile PSI

FDA 510(k)

FDA Class 2 ·Orthopedic

COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MONITRODE

FDA 510(k)

FDA Class 2 ·Cardiovascular

SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

WiEMSpro

FDA 510(k)

FDA Class 2 ·Physical Medicine

ROSA SURGICAL DEVICE

FDA 510(k)

FDA Class 2 ·Neurology

NOVEL PRINT CYAN ALGINATES

FDA 510(k)

FDA Class 2 ·Dental

COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION

FDA 510(k)

FDA Class 2 ·Dental

Activmotion Range

FDA 510(k)

FDA Class 2 ·Orthopedic

MORPHINE ROCHE (R) EIA TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

REVISED LABELING FOR BENZODIAZEPINE TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

REVISED LABELING FOR COCAINE/COCAINE META. TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology