VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

NIZYME TEST KIT

FDA 510(k)

FDA Class 1 ·Microbiology

AMOXICILLIN/CLAVULANIC ACID 2/1

FDA 510(k)

FDA Class 2 ·Microbiology

ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

TITANIUM PEG SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC

FDA 510(k)

FDA Class 2 ·Immunology

ETEST FOR CEFUROXIME

FDA 510(k)

FDA Class 2 ·Microbiology

APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1

FDA 510(k)

FDA Class 2 ·Immunology

SYNCHRONY RESPIRATORY TRACKING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL SYSTEMS AND ND:YAG LASER SYSTEMS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BACTIDROP PYR

FDA 510(k)

FDA Class 1 ·Microbiology

PIPERACILIN TAZOBACTAM 4 UG

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST SUBMISSION FOR AMOXICILLIN

FDA 510(k)

FDA Class 2 ·Microbiology

ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RANIR HI-TECHNOLOGY DENTAL FLOSS

FDA 510(k)

FDA Class 1 ·Dental

FlareHawk Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

STICK-GARD SAFETY NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

PENN 3-RING HANDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PIPERACILLIN/TAZOBACTAM 4

FDA 510(k)

FDA Class 2 ·Microbiology

BACTIDROP(TM) MUCAP

FDA 510(k)

FDA Class 1 ·Microbiology