Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·DEKLENE(TM)

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·SURGILENE

CPR PLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Carex Hybrid Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LARGE/EXTRA LAGRE CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BLACK COLOURED CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

NATURAL RUBBER LATEX MALE CONDOMS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ORANGE COLORED CONDOMS ORANGE SCENT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

POLLER CALIBRANTS

FDA 510(k)

FDA Class 2 ·Hematology

MODEL 617 CARDIAC OUTPUT COMPUTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ß-Glucocerebrosidase (Gba) Newborn Screening Test System

FDA classification

FDA Class 2 ·ß-Glucocerebrosidase (Gba) Newborn Screening Test System

Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms

FDA classification

FDA Class 2 ·Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·PowerLook® Tomo Detection Software

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

FDA classification

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

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