LEAP MONO TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

Intellitorq

FDA 510(k)

FDA Class 1 ·Orthopedic

RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

TRANSAMERICAN CLASSIC TENS

FDA 510(k)

FDA Class 2 ·Neurology

PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

Nitinol Compression Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CONBIO CUB-D10 COOPER LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMBULATORY PH DATA RECORDER SYSTEM, APH-2000

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DISPOSABLE PULMONARY FUNCTION FILTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS

FDA 510(k)

FDA Class 2 ·Cardiovascular

J-CATH, GISH MODEL NO. JVAC-XXXX

FDA 510(k)

FDA Class 2 ·Cardiovascular

15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND: YAG LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX

FDA 510(k)

FDA Class 2 ·General Hospital

PRE-BYPASS FILTER #EC-PBF SERIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLOSED CHEST DRAINAGE SET

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery