ACRYL-X II SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO: INSTAREAD LITHIUM SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VICRYL * MESH BAG

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

ARBO VS MONITOR CABLE & LEADWIRE SYSTEM ARBO SHIELDED SAFETY CABLE & LEAD WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PENTAX Medical Video Duedenoscope ED34-i10T2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

gammaCore Sapphire

FDA 510(k)

FDA Class 2 ·Neurology

TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GYNECARE TVT SECUR SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

POLARIS SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BEND-A-BEAM HAND CONTROL MALLEABLE ABC HANDPIECE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CARDIAC SCORING FOR CT SCANNERS

FDA 510(k)

FDA Class 2 ·Radiology

VERIFY VH2O2 Indicator Tape

FDA 510(k)

FDA Class 2 ·General Hospital

ELECATH OPEN TIP BIPOLAR PACING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DC

FDA 510(k)

FDA Class 2 ·Immunology

TROJAN EXTRA STRENGTH LUBRI. CONDOMS MODI. LABEL

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ES2 SPINAL SYSTEM MODEL 48280XXXX

FDA 510(k)

FDA Class 2 ·Orthopedic

PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat