MODEL 493 SSR-3 THREE CHANNEL SOLID-STATE RECORDER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARESIDE DIRECT BILIRUBIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SEIRIN ACUPUNCTURE NEEDLES

FDA 510(k)

FDA Class 2 ·General Hospital

NE-U04/NE U04F

FDA 510(k)

FDA Class 2 ·Anesthesiology

ALLEN, ULTRA AND SMART SOCKETS

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

MARCO H AND TS-1 INSTRUMENT TABLES

FDA 510(k)

FDA Class 1 ·Ophthalmic

MYOCARDIAL PROTECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EG-2940, VIDEO GASTROSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMBRO-ENGSTROM ERICA IV RESPIRATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

DRAINAGE CATHETERS W/A DISSOLVABLE TIP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CARESIDE ANALYZER

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

OXLIFE OXYGEN CONCENTRATORS

FDA 510(k)

FDA Class 2 ·Anesthesiology

22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR

FDA 510(k)

FDA Class 2 ·Radiology

CARESIDE CHOLINESTERASE

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)

FDA 510(k)

FDA Class 1 ·Orthopedic

OSTEOMARK NTX POC

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC RETRIEVAL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology