DIP Arthrodesis System

FDA 510(k)

FDA Class 2 ·Orthopedic

IPL Hair Removal Device (BE965A, BE965B, BE965C)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IPL Hair Removal Device (BE932C, BE932D, BE932E)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses

FDA 510(k)

FDA Class 2 ·Ophthalmic

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 ·COBAS AMPLICOR HCV TEST

AIP SYSTEM-METHOD FOR IGM

FDA 510(k)

FDA Class 2 ·Immunology

'RAPIDTEC' 5A MULTIPLE DIP TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

NO-STICK COMPOSITE INSTRUMENT DIP

FDA 510(k)

FDA Class 2 ·Dental

'RAPIDTEC'-5M-MULTIPLE DIP TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BILATERAL IMPEDANCE PLETHYSMOGRAPH, BIP(TM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

AIP INTENSE PULSED LIGHT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN

FDA 510(k)

FDA Class 2 ·General Hospital

Models 2200DR and 1600DR Digital Stationary Radiographic Systems

FDA 510(k)

FDA Class 2 ·Radiology

MANAN ADAPTER FOR BIP BIOPSY DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIP/U.S. Urine Analysis Test System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology