DEBP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

NG-Test CARBA 5

FDA 510(k)

FDA Class 2 ·Microbiology

RAPIDEC CARBA NP

FDA 510(k)

FDA Class 2 ·Microbiology

NG-Test® CTX-M MULTI

FDA 510(k)

FDA Class 2 ·Microbiology

Quantum Mitohormesis (QMT) (M2101)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Aquilion Precision (TSX-304A/4) V10.14 with AiCE

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion ONE (TSX-305A/6) V8.9 with AiCE

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Precision (TSX-304A/4) V10.10 with AiCE

FDA 510(k)

FDA Class 2 ·Radiology

AutoMIStar

FDA 510(k)

FDA Class 2 ·Radiology

ZED Link

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i

FDA 510(k)

FDA Class 2 ·Radiology

KINGLY STAR POWERED MUSCLE STIMULATOR, MODEL KS-138

FDA 510(k)

FDA Class 2 ·Physical Medicine

BACTEC MGIT 960 SIRE KITS

FDA 510(k)

FDA Class 2 ·Microbiology

BBLCHROMAGAR MRSA

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN GRAM POSITIVE

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GN) 0.5-32UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST

FDA 510(k)

FDA Class 2 ·Microbiology

AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery