AMBULATORY MARK XI DRUG INFUSION DEV-

FDA 510(k)

FDA Class 2 ·General Hospital

MEDI-TRACE DISP. FLUSHING DEV./MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANGIO-FLO CONTIN-ARTERIAL FLUSH DEV.

FDA 510(k)

FDA Class 2 ·Cardiovascular

DU PONT ACA NEV/EEV VERIFIER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TOPICAL COOLING DEV. TCD. #27-999

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARGYLE RIGID URINE MEASURING/COLL. DEV.

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RELEASE OF ETHYLENE OXIDE-STERILIZ. DEV

FDA 510(k)

FDA Class 2 ·General Hospital

XENAMATIC SERIES OF XENON REBREATH DEV

FDA 510(k)

FDA Class 2 ·Radiology

KANEDA ANTERIOR SPINAL MULTISEGMENTAL FIXATION DEV

FDA 510(k)

FDA Class 2 ·Orthopedic

DISP. METAL & PLASTIC ELECTROSURG. DEV

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MIS CONNECT Conical Connection Abutment

FDA 510(k)

FDA Class 2 ·Dental

MIS LOCKiT Abutments System, OT-Equators and Ball Attachments

FDA 510(k)

FDA Class 2 ·Dental

MIS Internal Hex Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments

FDA 510(k)

FDA Class 2 ·Dental

MIS V3 Conical Connection Dental Implant System­

FDA 510(k)

FDA Class 2 ·Dental

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM 151 (PAFLUFOCON D) CLEAR & TINTS W/O UV

DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ENVIEW (TM)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MANDOMETER III

FDA 510(k)

FDA Class 2 ·Neurology

KSEA ENDOSCOPE HOLDER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology