LG-150-CNN

FDA UDI

LASER PERIPHERALS, LLC·00816469021032·LaseGuide™ Connect Nav 150u Laser Fiber

LG-250-CNN

FDA UDI

LASER PERIPHERALS, LLC·00816469021216·LaseGuide™ Connect Nav 250u Laser Fiber

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·(QON) InterStim® Therapy System, Verify® Evaluation System

GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BETA-HCG MICROTITER PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

87 NeuGlide Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEONATAL CANNULA CAP

FDA 510(k)

FDA Class 2 ·Anesthesiology

PREGNA/TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EnSite X EP System

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN)

FDA 510(k)

FDA Class 1 ·Anesthesiology

SNR-3000 UPGRADE RECEIVER COILS

FDA 510(k)

FDA Class 2 ·Radiology

HUMAN CHORIONIC GONAD TEST SYS FOR EARLY PREGNANCY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST

FDA 510(k)

FDA Class 2 ·Immunology

PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

ANTINUCLEAR ANTIBODY TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

93 NeuFlex Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Hi-Dow Pro-Tech

FDA UDI

Hi-Dow International Incorporated·00851640007467·Wireless Receiver

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE