LIFESCOPE 8 DEC-8108A AND DEC-8204A

FDA 510(k)

FDA Class 2 ·Cardiovascular

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

RFG-DGP DISPOSABLE GROUNDING PADS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ULTRASONIC TRANSMISSION GEL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ULTRASOUND COUPLING GEL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

R2 ELECTROSURG. RETURN ELECT. #225ETC.

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ULTRASOUND TRANSDUCER GEL, STERILE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

STERILE ULTRASOUND TRANSMISSION GEL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

STERILIZED OMNI GEL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRIA-SONIC ULTRA SOUND TRANSMISSION GEL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ULTRASOUND TRANSMISSION GEL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PQ1

FDA 510(k)

FDA Class 2 ·Dental

ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)

FDA 510(k)

FDA Class 2 ·Microbiology

ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control

FDA 510(k)

FDA Class 2 ·Microbiology

Atellica IM High-Sensitivity Troponin I (TNIH)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA Centaur Enhanced Liver Fibrosis (ELF)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA Centaur High-Sensitivity Troponin I (TNIH)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MDI MII ONE-PIECE IMPLANT, 2.9MM

FDA 510(k)

FDA Class 2 ·Dental

CLINICAL ALERT NOTIFICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

ADVIA Centaur TSH3-Ultra

FDA 510(k)

FDA Class 2 ·Clinical Chemistry