ART-ASSIST MODEL AA-1000

FDA 510(k)

FDA Class 2 ·Cardiovascular

3301 PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)

FDA 510(k)

FDA Class 2 ·Hematology

FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

6% ORTHO LOLIUDINE REAGENT IN GLACID ACI

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RASTRONICS CCI 10/3 HEARING AID ANALYSIS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·ULTRA2 CUTTING BALLOON MONORAIL(MR)

INFX-8000C (INFINIX CC-I AND VC-I)

FDA 510(k)

FDA Class 2 ·Radiology

Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)

FDA 510(k)

FDA Class 2 ·Neurology

Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medical Surgical Mask (Non-sterile)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HCV TEST VERSION 2.0

CAPILLARY SAMPLE LINE

FDA 510(k)

FDA Class 2 ·Anesthesiology

SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SODIUM REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CO2/02 MONITOR MULTINEX

FDA 510(k)

FDA Class 2 ·Anesthesiology

SODIUM REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry