BIOTEQ Drainage Catheter BT-PDS-series

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INDEX BPM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear

FDA 510(k)

FDA Class 2 ·Ophthalmic

Si-Hy (olifilcon B) color silicone hydrogel soft contact lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

Everyway Facial MENS

FDA 510(k)

FDA Class 2 ·Neurology

WU'S 4-WHEELED NEO SCOOTER, MODEL WT-M4A

FDA 510(k)

FDA Class 2 ·Physical Medicine

MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MERRIES UNI-OSTEO, MODEL CS30250-CS10102

FDA 510(k)

FDA Class 2 ·Orthopedic

KYMCO FORU, MODEL EQ40

FDA 510(k)

FDA Class 2 ·Physical Medicine

HIVOX EAR THERMOMETER, TS SERIES

FDA 510(k)

FDA Class 2 ·General Hospital

EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses

FDA 510(k)

FDA Class 2 ·Ophthalmic

OXICARE FINGERTIP PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)

FDA 510(k)

FDA Class 2 ·Neurology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS OTW SOLARIS CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL & OVER-THE-WIRE

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 and COBAS TaqMan HCV TEst, v2.0 for use on the High Pure System