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

SHERPA GUIDING CATHETER WITH CATHETER INTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ELECTRONIC PULSE STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® Transforaminal Lumbar Interbody Fusion device (TLIF); aprevo® Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X)

FDA 510(k)

FDA Class 2 ·Orthopedic

Wearable Breast Pump (Model S10)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SeaSpine Reef TH System

FDA 510(k)

FDA Class 2 ·Orthopedic

Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Medical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MIKRO-CATH, MODEL 825-0101

FDA 510(k)

FDA Class 2 ·Cardiovascular

electrocardiograph: SE-1202

FDA 510(k)

FDA Class 2 ·Cardiovascular

TAMA BEMS device

FDA 510(k)

FDA Class 2 ·Neurology

Dolphin Blue Imaging

FDA 510(k)

FDA Class 2 ·Radiology

iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALBOGRAFT VASCULAR PROSTHESIS

FDA 510(k)

FDA Class 2 ·Cardiovascular

WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

PeriCoach OTC

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Onrad Treatment System

FDA 510(k)

FDA Class 2 ·Radiology

Seaspine WaveForm C Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

SeaSpine WaveForm™ A Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic