SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE

FDA 510(k)

FDA Class 2 ·Radiology

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·CSI (CROFILCON A) EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·RAY TFC UNITE PRODUCT LINE

OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR

FDA 510(k)

FDA Class 2 ·Anesthesiology

R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005

FDA 510(k)

FDA Class 2 ·General Hospital

AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFT MATE COMFORT DROPS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFTMATE SOLUTION

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETERS AND TRAPPER EXCHANGE DEVICE

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFTMATE SALINE SOLUTION FOR SENSITIVE EYES

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·GAS PERMEABLE COMFORTCARE(TM)WETTING/SOAKING SOLUT

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·USE OF RED PLASTIC PLUG WITH CONCEPT -1 SOLUTION

OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Mesh, Surgical, Polymeric

FDA Pre-Market Approval

FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALLERGAN(R) HYDROCARE(R) CLEAN & DISINFECT SOLUTIO

Enzyme Immunoassay, Cannabinoids

FDA Pre-Market Approval

FDA Class 2 ·DR. BROWN'S HOME DRUG TESTING KIT