AIA-PACK TPOAB ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

STERI-PAK BOWIE DICK TEST PACK

FDA 510(k)

FDA Class 2 ·General Hospital

Apogee

FDA 510(k)

FDA Class 2 ·Anesthesiology

STERI-PAK LF BOWIE-DICK TEST PACK

FDA 510(k)

FDA Class 2 ·General Hospital

ANSELL CONDOMS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LIFESTYLES XTRA PLEASURE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Clear Aligner

FDA 510(k)

FDA Class 2 ·Dental

SPECULITE DISPOSABLE VAGINAL LIGHT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LIFESTYLES LIQUID PERSONAL LUBRICANT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON

FDA 510(k)

FDA Class 2 ·Cardiovascular

VITEK 2 STRPTOCOCCUS AMPICILLIN

FDA 510(k)

FDA Class 2 ·Microbiology

MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE (0.5-128 UG/ML)

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID

FDA 510(k)

FDA Class 2 ·Microbiology

BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology