MODIFICATION TO: INION OTPS BIODEGRADABLE PIN

FDA 510(k)

FDA Class 2 ·Orthopedic

PM 2002 CC PROLINE

FDA 510(k)

FDA Class 2 ·Dental

DC-Air and Athlos-1 and Athlos-Air

FDA 510(k)

FDA Class 2 ·Dental

RESUBMITTED MODIFIED RUBALEX

FDA 510(k)

FDA Class 2 ·Microbiology

Inion BioRestore

FDA 510(k)

FDA Class 2 ·Orthopedic

MoisturemeterD

FDA 510(k)

FDA Class 2 ·Cardiovascular

OSCAROXY(TM) GAS MONITOR AND PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

DIGORA OPTIME

FDA 510(k)

FDA Class 2 ·Dental

CARDIOCAP(TM) CT-104 MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ALPHA STEREO

FDA 510(k)

FDA Class 2 ·Radiology

URIC ACID (AOX), SCAL, NORTROL, ABTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Planmed Verity

FDA 510(k)

FDA Class 2 ·Radiology

AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD

FDA 510(k)

FDA Class 2 ·Anesthesiology

ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257

FDA 510(k)

FDA Class 2 ·Immunology

Orthopantomograph™ OP 3D LX

FDA 510(k)

FDA Class 2 ·Radiology

DIGORA OPTIME (OR DIGORA ONTIME)

FDA 510(k)

FDA Class 2 ·Dental

BonAlive Granules

FDA 510(k)

FDA Class 2 ·Orthopedic

HAAG-STREIT FUNDUS MODULE 300

FDA 510(k)

FDA Class 2 ·Ophthalmic

AS/3 PRESSURE TEMPERATURE MODULE, M-PT

FDA 510(k)

FDA Class 2 ·Cardiovascular

Nexstim Navigated Brain Therapy (NBT) System 2

FDA 510(k)

FDA Class 2 ·Neurology