LATELET, CONTROL, NORMAL & ABNORMAL

FDA 510(k)

FDA Class 2 ·Hematology

Lumenis Stellar M22

FDA 510(k)

FDA Class 2 ·Ophthalmic

ASAHI AM SERIES DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFIED SEPACELL R-SERIES BLOOD FILTERS

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT

FDA 510(k)

FDA Class 2 ·General Hospital

HEMOSORBA CH-500, CH-350 AND CH-180

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SEPACELL R-500 & SEPACELL R-500A

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BLOOD PLATELET ASSAY METHOD & APPARATUS

FDA 510(k)

FDA Class 2 ·Hematology

MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS

FDA 510(k)

FDA Class 2 ·General Hospital

NEW AM-SERIES DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SEPACELL R-500 AND SEPACELL R-500A

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFIED AM-SERIES DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·CELSIUS and EZ STEER

HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·EZ Steer Navigational 4mm (TC)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BAUSCH & LOMB(R) RENU(R) MULTI-PURPOSE SOLUTION

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·Navistar EP, EZ Steer Nav Bi-Directional

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·Navistar, Navistar RMT, EZ Steer Nav Bi-directional

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·EZ Steer Thermocool Nav Bi-Directional Electrophysiology Catheter