HomeSleepTest (HST, HST REM+)

FDA 510(k)

FDA Class 2 ·Neurology

Falcon HST

FDA 510(k)

FDA Class 2 ·Neurology

Silk'n HST

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RAPICURE 200 (CURING AND WHITENING LIGHT)

FDA 510(k)

FDA Class 2 ·Dental

DEFI 2

FDA 510(k)

FDA Class 2 ·Cardiovascular

DYMAXEON SPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MONOPOLY PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

VALEO PEDICLE SCREW SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

VALEO PEDICLE SCREW SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES

FDA 510(k)

FDA Class 2 ·Ophthalmic

MIDLINE II TI

FDA 510(k)

FDA Class 2 ·Orthopedic

VALEO VBR

FDA 510(k)

FDA Class 2 ·Orthopedic

VALEO CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SEEPLATE CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO VALEO VBR

FDA 510(k)

FDA Class 2 ·Orthopedic

SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

1ST IMPRESSION

FDA 510(k)

FDA Class 2 ·Dental

1ST IMPRESSION

FDA 510(k)

FDA Class 2 ·Dental

1ST MTP PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE

FDA 510(k)

FDA Class 2 ·Anesthesiology