ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100

FDA 510(k)

FDA Class 2 ·Ophthalmic

LOVESAFE DOTTY CONDOM ONE DZ. CODOMS/BOX, DC-20

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ARGON ACCESSORY WITH BLADE & NEEDLE ELECTRODE, ADAPTER BOX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Atmo Gas Capsule System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Stealth-Midas MR8 System

FDA 510(k)

FDA Class 2 ·Neurology

Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories

FDA 510(k)

FDA Class 2 ·Neurology

ULTRATONE 8+ & 20

FDA 510(k)

FDA Class 2 ·Physical Medicine

AIR MASSAGE SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box

FDA 510(k)

FDA Class 2 ·Cardiovascular

Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)

FDA 510(k)

FDA Class 2 ·Neurology

LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/BOX PC-30

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OX-GEN FLEXIBLE O2 GENERATION SYSTEM, MODEL 6-OX-03

FDA 510(k)

FDA Class 2 ·Anesthesiology

Mesh, Surgical, Polymeric

FDA Pre-Market Approval

FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT

HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER

FDA 510(k)

FDA Class 2 ·General Hospital

VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COLORPOINT 1720 MEDICAL IMAGERS AND VIDEO CAPTURE BOX CX-1000 SERIES

FDA 510(k)

FDA Class 2 ·Radiology

PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CUTTING BALLOON ULTRA2 MONORAIL (MR) PTCA CATHETER (CUTTING BALLOON)

NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX

FDA 510(k)

FDA Class 2 ·Neurology