LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586

FDA 510(k)

FDA Class 2 ·Dental

Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems

FDA 510(k)

FDA Class 2 ·Medical Genetics

Quantidex qPCR BCR-ABL IS Kit

FDA 510(k)

FDA Class 2 ·Medical Genetics

QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

FDA 510(k)

FDA Class 2 ·Medical Genetics

BCR-ABL1 (p210) % IS Kit (Digital PCR Method)

FDA 510(k)

FDA Class 2 ·Medical Genetics

JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE

FDA 510(k)

FDA Class 2 ·Orthopedic

ProdiGI

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Emprint Ablation System with Thermosphere Technology

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Emprint SX Ablation Platform with Thermosphere Technology

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MEDIZIV CENTRAL VEIN CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDIZIV EPIDURAL SYSTEMS

FDA 510(k)

FDA Class 2 ·Anesthesiology

HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX

FDA 510(k)

FDA Class 2 ·Orthopedic

HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

EndoflipTM 300

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cool-tip RF Ablation System E Series

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

FDA Pre-Market Approval

FDA Class 2 ·Alinity m HCV

LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM

FDA 510(k)

FDA Class 2 ·Orthopedic

SFI-BAR IMPLANT ABUTMENTS

FDA 510(k)

FDA Class 2 ·Dental

Pectus Support Bar System

FDA 510(k)

FDA Class 2 ·Orthopedic

LORENZ PECTUS SUPPORT BAR

FDA 510(k)

FDA Class 2 ·Orthopedic