Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS(R) RX FLOWTRACK(TM) 40 CORONARY DILITATIN CATH

ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307

FDA 510(k)

FDA Class 2 ·Immunology

QUIBIM Precision Prostate (qp-Prostate)

FDA 510(k)

FDA Class 2 ·Radiology

Fas Aligner System

FDA 510(k)

FDA Class 2 ·Dental

WasherCap™ Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

BTI Dental Implant System UnicCa

FDA 510(k)

FDA Class 2 ·Dental

BTI Interna Narrow/Plus Dental Implant System UnicCa

FDA 510(k)

FDA Class 2 ·Dental

TOF-Cuff monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Classic

FDA 510(k)

FDA Class 2 ·Dental

Amecath Peripheral inserted Central Venous Catheter Sets

FDA 510(k)

FDA Class 2 ·General Hospital

DOSI-FLOW, MODELS 20 & 30

FDA 510(k)

FDA Class 2 ·General Hospital

CeraRoot TL Implant System (TL)

FDA 510(k)

FDA Class 2 ·Dental

V7 PORTABLE SUCTION UNITS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ADAS 3D

FDA 510(k)

FDA Class 2 ·Radiology

HC-1 AND HC-1 CLASSIC

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ADVIA Centaur Herpes-1 IgG

FDA 510(k)

FDA Class 2 ·Microbiology

DESS Dental Smart Solutions

FDA 510(k)

FDA Class 2 ·Dental

elysion-pro

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.

FDA 510(k)

FDA Class 2 ·Cardiovascular