NEPHROCHECK TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·TRANS AIRE (TM) RIGID GAS PERMEABLE CONTACT LENS

OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

LIQUID NITROGEN SPRAY UNIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER

FDA 510(k)

FDA Class 2 ·General Hospital

VERSALET 7700 CARE CENTER, MODEL # 7700

FDA 510(k)

FDA Class 2 ·General Hospital

VARIABLE HIGH FLOW DOWNS CPAP GENERATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

NEONATAL INCUBATOR (ACCESSORY)

FDA 510(k)

FDA Class 2 ·General Hospital