SERODIA ATG

FDA 510(k)

FDA Class 2 ·Immunology

ATG/SM-OSA APPLIANCES

FDA 510(k)

FDA Class 2 ·Dental

ASSERACHROM B-TG KIT

FDA 510(k)

FDA Class 2 ·Hematology

BTG SMARTEST GLUCOSE TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GYREX PRIMA 1TG 1.0T MRI SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml

FDA 510(k)

FDA Class 2 ·Microbiology

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER

IDECAP DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

ECUSIT COMPOSITE REPAIR

FDA 510(k)

FDA Class 2 ·Dental

QUANTASE PHENYLALANINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry