Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MICRO-PACE MODEL 4553 DUAL CHAMBER DDD TEMPORARY CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA classification

FDA Class 2 ·Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

PORTA 100HF

FDA 510(k)

FDA Class 2 ·Radiology

INSIDE JOB

FDA 510(k)

FDA Class 2 ·Orthopedic

Neurovision Nerve Locator Monitor (Nerveana), EMGView Software

FDA 510(k)

FDA Class 2 ·Neurology

Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm

FDA 510(k)

FDA Class 2 ·Anesthesiology

Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm

FDA 510(k)

FDA Class 2 ·Anesthesiology

QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols

FDA 510(k)

FDA Class 2 ·Immunology

VALVE, ANTI-SYPHON MODEL PUDENZE FLUSH.

FDA 510(k)

FDA Class 2 ·Neurology

ANTI-JO-1 MICROASSAY

FDA 510(k)

FDA Class 2 ·Immunology

VARELISA JO-1 ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

ELISA-DOXA JO-1

FDA 510(k)

FDA Class 2 ·Immunology

SYNELISA JO-1 ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

V/X ASPHERIC TORIC MULTIFOCAL (POLYMACON) SOFT (HYDROPHILIC) LENSES WITH A CLEAR OR BLUE VISIBILITY TINT

FDA 510(k)

FDA Class 2 ·Ophthalmic

JO-1 EIA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

ORGENTEC ANTI-JO-1 ELISA

FDA 510(k)

FDA Class 2 ·Immunology