IBL 5000 Tanning Booth

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MRDx BCR-ABL Test, MRDx BCR-ABL Test Software

FDA 510(k)

FDA Class 2 ·Medical Genetics

BIRDS'N BEES CONDOMS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MAMBA CONDOM (RUBBER LATEX)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MANUEL SAFTEY SYRINGE PARTS 1 & 2

FDA 510(k)

FDA Class 2 ·General Hospital

Automated Blood Coagulation Analyzer CS-2500

FDA 510(k)

FDA Class 2 ·Hematology

Sysmex Automated Blood Coagulation Analyzer CS-2100i

FDA 510(k)

FDA Class 2 ·Hematology

CONDOM (RUBBER LATEX) OKEIDO

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SureTouch Mobile Pressure Mapping System

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DYNAWELL OR DYNAWELL

FDA 510(k)

FDA Class 2 ·Radiology

Sysmex Automated Blood Coagulation Analyzer CS-2100i

FDA 510(k)

FDA Class 2 ·Hematology

CONDOM (RUBBER LATEX) KILROY

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Sysmex Automated Blood Coagulation Analyzer CS-5100

FDA 510(k)

FDA Class 2 ·Hematology

PROFIL CONDOM (RUBBER LATEX)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CUFF-ABLE PLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

BBL GASPAK POUCH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PROFILE BBL SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ABL 735 ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABL SYSTEM 620

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC