Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems

FDA 510(k)

FDA Class 2 ·Radiology

STERISPINE CC

FDA 510(k)

FDA Class 2 ·Orthopedic

STERISPINE PS

FDA 510(k)

FDA Class 2 ·Orthopedic

STERISPINE LC CAGE

FDA 510(k)

FDA Class 2 ·Orthopedic

Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MDx-Chex for BC-GN

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Warrior Control Panel M290

FDA 510(k)

FDA Class 2 ·Microbiology

SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)

FDA 510(k)

FDA Class 2 ·Microbiology

BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire RP2.1/RP2.1plus Control Panel M441

FDA 510(k)

FDA Class 2 ·Microbiology

Cepheid Xpert GBS LB Control Panel

FDA 510(k)

FDA Class 2 ·Microbiology

SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray RP EZ Control Panel M265

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray RP2/RP2plus Control Panel

FDA 510(k)

FDA Class 2 ·Microbiology

SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control

FDA 510(k)

FDA Class 2 ·Microbiology

NATtrol BD MAX Vaginal Panel External Controls

FDA 510(k)

FDA Class 2 ·Microbiology

MDx-Chex for BC-GP

FDA 510(k)

FDA Class 2 ·Microbiology

Cepheid Xpert CT/NG Control Panel

FDA 510(k)

FDA Class 2 ·Microbiology

MDx-Chex for BCID2

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray BCID2 Control Panel M416

FDA 510(k)

FDA Class 2 ·Microbiology