Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·INTER FIX THREADED FUSION DEVICE, INTER FIX RP THREADED FUSION DEVICE AND LT-CAGE LUMBAR TAPERED FUSION DEVICE

Resuscitator, Manual, Non Self-Inflating

FDA classification

FDA Class 2 ·Resuscitator, Manual, Non Self-Inflating

Bag, Hemostatic

FDA classification

FDA Class 2 ·Bag, Hemostatic

Isocapnic Ventilation Device

FDA classification

FDA Class 2 ·Isocapnic Ventilation Device

Vaporizer, Anesthesia, Non-Heated

FDA classification

FDA Class 2 ·Vaporizer, Anesthesia, Non-Heated

Apparatus, Autotransfusion

FDA classification

FDA Class 2 ·Apparatus, Autotransfusion

General Laparoscopic Power Morcellation Containment System

FDA classification

FDA Class 2 ·General Laparoscopic Power Morcellation Containment System

Bag, Bile Collecting

FDA classification

FDA Class 2 ·Bag, Bile Collecting

Bag, Urine Collection, Newborn

FDA classification

FDA Class 2 ·Bag, Urine Collection, Newborn

Catheter, Retention, Barium Enema With Bag

FDA classification

FDA Class 2 ·Catheter, Retention, Barium Enema With Bag

Cryogenic Cord Blood Storage Container

FDA classification

FDA Class 2 ·Cryogenic Cord Blood Storage Container

GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SYNERMED ISE REAGENTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARTHROTAP

FDA 510(k)

FDA Class 2 ·General Hospital

Lucent : IPL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

XactTrace Single Use Respiratory Effort Belt System

FDA 510(k)

FDA Class 2 ·Anesthesiology

TruPlan

FDA 510(k)

FDA Class 2 ·Radiology

HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN

FDA 510(k)

FDA Class 2 ·Hematology

THERAPLAN PLUS VERSION 1.2

FDA 510(k)

FDA Class 2 ·Radiology