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

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

Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Lifetech Cardio Model 8301 Temporary Pacemaker

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

CO2/02 MONITOR MULTINEX

FDA 510(k)

FDA Class 2 ·Anesthesiology

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST

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

FDA Pre-Market Approval

FDA Class 2 ·ROCHE MOLECULAR SYSTEMS COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS ANTI-HCV

LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DENSICOMP 250

FDA 510(k)

FDA Class 2 ·Radiology

TaiChiC

FDA 510(k)

FDA Class 2 ·Radiology

IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable Endoscope Valves System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology