LungQ Software

FDA 510(k)

FDA Class 2 ·Radiology

MAMMAPRINT

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO MAMMAPRINT

FDA 510(k)

FDA Class 2 ·Immunology

Transpara (2.1.0)

FDA 510(k)

FDA Class 2 ·Radiology

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

FDA 510(k)

FDA Class 2 ·Microbiology

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

FDA 510(k)

FDA Class 2 ·Microbiology

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

FDA 510(k)

FDA Class 2 ·Microbiology

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

FDA 510(k)

FDA Class 2 ·Microbiology

TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET

FDA 510(k)

FDA Class 2 ·Microbiology

Smith & Nephew Tablet Application

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Nephroscope Set

FDA classification

FDA Class 2 ·Nephroscope Set

Self-Fitting Air-Conduction Hearing Aid, Over The Counter

FDA classification

FDA Class 2 ·Self-Fitting Air-Conduction Hearing Aid, Over The Counter

Set, Dialyzer Holder

FDA classification

FDA Class 2 ·Set, Dialyzer Holder

Set, Oral Administration

FDA classification

FDA Class 2 ·Set, Oral Administration

Stopcock, I.V. Set

FDA classification

FDA Class 2 ·Stopcock, I.V. Set

Set, Anesthesia, Pudendal

FDA classification

FDA Class 2 ·Set, Anesthesia, Pudendal

Set, Anesthesia, Paracervical

FDA classification

FDA Class 2 ·Set, Anesthesia, Paracervical

Set, Anesthesia, Obstetric

FDA classification

FDA Class 2 ·Set, Anesthesia, Obstetric

Set, Blood Transfusion

FDA classification

FDA Class 2 ·Set, Blood Transfusion