EASYLYTE CALCIUM/CHLORIDE ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AZTREONAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology

MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

REVISED LABELING FOR SYVA METHAQUALONE ASSAYS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CinchLock Flex Knotless Suture Anchor

FDA 510(k)

FDA Class 2 ·Orthopedic

RTHawk, HeartVista Cardiac Package

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO LNCS OXIMETRY SENSORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

FOX SV PTA CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

SANDMAN INTRO

FDA 510(k)

FDA Class 2 ·Anesthesiology

LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE

FDA 510(k)

FDA Class 2 ·Neurology

Elite iQ PRO (M122K1)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

da Vinci SP SureForm 45 Staplers and Reloads (SP1098)

FDA 510(k)

FDA Class 2 ·General Hospital

SALTER LABS INFANT NASAL CPAP CANNULA

FDA 510(k)

FDA Class 2 ·Anesthesiology

MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BIRD GRAPHICS MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

ANDROS ANALYZERS AIRWAY ADAPTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

TEPHAFLEX ABSORBABLE SUTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery