Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OCU-FLEX

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OCU-FLEX

OCU-GUARD AND OCU-GUARD SUPPLE

FDA 510(k)

FDA Class 2 ·Ophthalmic

Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Aulisa Temperature Module (TM0002)

FDA 510(k)

FDA Class 2 ·General Hospital

Stereotaxic Guiding Surgical Devices, NaoTrac S

FDA 510(k)

FDA Class 2 ·Neurology

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OCU-FLEX-53 SOFT CONTACT LENSES

OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP

FDA 510(k)

FDA Class 2 ·Ophthalmic

OCU-FLEX-38 (POLYMACON)

FDA 510(k)

FDA Class 2 ·Ophthalmic

OCU-FILM TIP COVER

FDA 510(k)

FDA Class 2 ·Ophthalmic

WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WiScope Digital Endoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COALESCENT U-CLIP- AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401

FDA 510(k)

FDA Class 2 ·Immunology

NON-BIOABSORBABLE STAPLE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO: OCU-FILM TIP COVER

FDA 510(k)

FDA Class 2 ·Ophthalmic

Fixone Biocomposite Interference Screw

FDA 510(k)

FDA Class 2 ·Orthopedic