BBL GASPAK POUCH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFIED LABELING ON OKAMOTO HARMONY CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DANTEC EVOLUTION

FDA 510(k)

FDA Class 2 ·Neurology

PH BUFFERING PLASTIC APPLICATOR TAMPON

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OSSIX -PLUS

FDA 510(k)

FDA Class 2 ·Dental

HAIRMAX LASERCOMB

FDA 510(k)

FDA Class 2 ·Physical Medicine

ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

MITYVAC

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SPORTMESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EXTENDED CHIN IMPLANT STYLE II

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE

FDA 510(k)

FDA Class 2 ·Anesthesiology

U-MID PREFILLED NEBULIZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

FIXEL EXTERNAL FIXATION DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

OXYCON LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

CEFAXOLIN 30 MCG SENSI-DISC

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO CORLINK AUTOMATED ANASTOMOTIC DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SECURACATH UNIVERSAL

FDA 510(k)

FDA Class 2 ·General Hospital

ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OPTIMUM WETTING AND REWETTING DROP

FDA 510(k)

FDA Class 2 ·Ophthalmic

AIA-PACK FT4

FDA 510(k)

FDA Class 2 ·Clinical Chemistry