ASTar BC G- Kit and ASTar Instrument

FDA 510(k)

FDA Class 2 ·Microbiology

ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+

FDA 510(k)

FDA Class 2 ·Radiology

Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ScandiDos Delta4 Phantom+

FDA 510(k)

FDA Class 2 ·Radiology

Delta4 Insight

FDA 510(k)

FDA Class 2 ·Radiology

SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)

FDA 510(k)

FDA Class 2 ·Radiology

DiviTum TKa

FDA 510(k)

FDA Class 2 ·Immunology

VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG

FDA 510(k)

FDA Class 2 ·Microbiology

ENDOPATH TISSUE EXTRACTION CANNULA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOPATH ENDOSCOPIC SURGICAL INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MS-39

FDA 510(k)

FDA Class 2 ·Ophthalmic

Plexus

FDA 510(k)

FDA Class 2 ·Cardiovascular

JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

Cube Navigator

FDA 510(k)

FDA Class 2 ·Radiology

ENDOPATH DISPOSABLE FLEXIBLE SURGICAL CANNULA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

QUANTASE PHENYLALANINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ORIGIN TACKER SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ORIGIN PIXIE STIC INTRODUCER SLEEVE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOPATH II DISPOSABLE SURGICAL TROCAR & SLEEVE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology