System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE(R) EIA

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·COBAS BACT

OsOpia Synthetic Bone Void Filler

FDA 510(k)

FDA Class 2 ·Dental

POLLER CALIBRANTS

FDA 510(k)

FDA Class 2 ·Hematology

Radioimmunoassay, Cyclic Gmp

FDA classification

FDA Class 2 ·Radioimmunoassay, Cyclic Gmp

Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)

FDA classification

FDA Class 2 ·Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)

Gas Chromatography, Methadone

FDA classification

FDA Class 2 ·Gas Chromatography, Methadone

VivoSight Dx Topical OCT System

FDA 510(k)

FDA Class 2 ·Radiology

Arc Endocuff Glide AEG110 & AEG120

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VITROS Immunodiagnostic Products CEA Reagent Pack

FDA 510(k)

FDA Class 2 ·Immunology

CENTRAFIX EXTERNAL FIXATOR

FDA 510(k)

FDA Class 2 ·Orthopedic

Flexi-Seal PROTECT Fecal Management System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PICO SMOKERLYZER, MODEL EC-50

FDA 510(k)

FDA Class 2 ·Anesthesiology

EmbedMed

FDA 510(k)

FDA Class 2 ·Dental

Wearable breast pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DISPOS. I/A & IRRIGATION HANDPIECES

FDA 510(k)

FDA Class 2 ·Ophthalmic

MARQUETTE 1200 DEFIBRILLATION PADS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION OF MLT R694 RUBY LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BAWMED RESCUE MASK

FDA 510(k)

FDA Class 2 ·Anesthesiology

Habib EUS RFA

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery