XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065

FDA 510(k)

FDA Class 2 ·Microbiology

ILLUMINA MISEQDX PLATFORM

FDA 510(k)

FDA Class 2 ·Immunology

DIAMOND PROBE/PERIO 2000 SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZER

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/COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM, V2.0

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, COBAS TAQMAN HCV TEST,V2.0 FOR USE WITH THE HIGH PURE SYSTEM

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 AND COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM

Image Quality Analyzer (IQA)

FDA 510(k)

FDA Class 2 ·Radiology

SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

TRIFIT 700

FDA 510(k)

FDA Class 2 ·Cardiovascular

Range/Denali/Mesa Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

MATRx plus

FDA 510(k)

FDA Class 2 ·Anesthesiology

TD Clip

FDA 510(k)

FDA Class 2 ·Dental

Anatotemp Anatomic Dental Implant Healing Abutment

FDA 510(k)

FDA Class 2 ·Dental

THE UNIVERSAL CEMENT PLUG(TM)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TiUltra Implants and Xeal Abutments

FDA 510(k)

FDA Class 2 ·Dental

MATRx Plus

FDA 510(k)

FDA Class 2 ·Anesthesiology

MICROWARE 200

FDA 510(k)

FDA Class 2 ·Neurology

MATRx Plus

FDA 510(k)

FDA Class 2 ·Anesthesiology

Air Next (NVD-02)

FDA 510(k)

FDA Class 2 ·Anesthesiology