SHEER THIN AROMAS RED LATEX CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ADVANCE STOPCOCKS ADVANCE MANIFOLDS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ADVANCE MEDICAL DESIGNS FLUID POUCH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

THE KARL STORZ UROMAT(TM)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ULTRALITE HF1236 HAND AND FOOT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GENESIS TM FETAL SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MODIFICATION TO: SPIRIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

Talos-C(HA) Cervical Intervertebral Body Fusion Devices

FDA 510(k)

FDA Class 2 ·Orthopedic

NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OTT INSUFFLATION FILTER TUBING

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BARD HYDROGEL-COATED DIAGNOSTIC URETHRAL CATHETERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HMP TITANIUM LOW PROFILE PORT

FDA 510(k)

FDA Class 2 ·General Hospital

STAINLESS STEEL SUTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)

FDA 510(k)

FDA Class 2 ·Orthopedic

CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FiteBac Cavity Cleanser

FDA 510(k)

FDA Class 2 ·Dental

PRECISEPLAN 2.0

FDA 510(k)

FDA Class 2 ·Radiology

CIRCUIT GUARD

FDA 510(k)

FDA Class 2 ·Anesthesiology

ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5

FDA 510(k)

FDA Class 2 ·Radiology

OXYGEN CONCENTRATOR, MODEL BX-5000

FDA 510(k)

FDA Class 2 ·Anesthesiology