AIR-CUSHION TOCOTONOMETER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FETASCAN 1500

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FIRST MEDIC MODEL 610P

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE

FDA 510(k)

FDA Class 2 ·Cardiovascular

FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BROWNE TST SINGLE USE BOWIE DICK TYPE TEST PACK

FDA 510(k)

FDA Class 2 ·General Hospital

BROWNE GA INDICATOR USE IN 2% ACTIV GLUTARALDEHYDE

FDA 510(k)

FDA Class 2 ·General Hospital

TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE

FDA 510(k)

FDA Class 2 ·General Hospital

KAY-PLUS & VARIOUS VANIA SANITARY LINERS & PADS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

APPRAISE-HRI

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle

FDA 510(k)

FDA Class 2 ·General Hospital

ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, ALTIVA CORPORATION CORPORATION NTR-3.3 MM SELF-TAPPING HA COA

FDA 510(k)

FDA Class 2 ·Dental