BioFire Joint Infection (JI) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

SDMO APPLICATOR CODE: ASN.8236

FDA 510(k)

FDA Class 1 ·Radiology

COBE ACUFLEX FSN, #15-208

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ASN MONITOR SINGLE NEEDLE MONITOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ANTI-DS/N-DNA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)

FDA 510(k)

FDA Class 2 ·General Hospital

ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS

FDA 510(k)

FDA Class 2 ·General Hospital

JOBST READY-TO-WEAR GAUNTLET

FDA 510(k)

FDA Class 2 ·General Hospital

Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact)

FDA 510(k)

FDA Unclassified ·Unknown

Ideal Med Pro 3-Ply Disposable Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

JOBST TRAVEL SOCKS

FDA 510(k)

FDA Class 2 ·General Hospital

Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

3MP GRAYSCAKE LCD DISPLAY

FDA 510(k)

FDA Class 2 ·Radiology

Disposable Ureteral Access Sheath

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

3MP COLOR LCD DISPLAY

FDA 510(k)

FDA Class 2 ·Radiology

Flowtron DVT5 Small Calf Garment

FDA 510(k)

FDA Class 2 ·Cardiovascular

Haemostasis Clips

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Dental Impression Material

FDA 510(k)

FDA Class 2 ·Dental

Surgical gowns

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

5MP GRAYSCALE LCD DISPLAY

FDA 510(k)

FDA Class 2 ·Radiology