MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INNOFLUOR THEOPHYLLINE ASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

WRDensity by Whiterabbit.ai

FDA 510(k)

FDA Class 2 ·Radiology

Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INNOFLUOR AMIKACIN ASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INNOFLOUR TOPIRAMATE REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INNOFLOUR CALIBRATOR REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INNOFLUOR QUINIDINE ASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CAPNO-FLO REGULATOR, CAPNO-FLO

FDA 510(k)

FDA Class 2 ·Anesthesiology

INTER-OS BONE GENERATOR

FDA 510(k)

FDA Class 2 ·Dental

BD MAX CT/GC/TV, BD MAX INSTRUMENT

FDA 510(k)

FDA Class 2 ·Immunology

INNOFLUOR PHENOBARBITAL ASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INNOFLUOR PHENYTOIN ASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INNOFLUOR GENTAMICIN ASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP

FDA 510(k)

FDA Class 2 ·Microbiology

SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

MALLARD MEDICAL MODEL 2400 ANESTHESIA VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology