AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CER-S

FDA 510(k)

FDA Class 2 ·Cardiovascular

DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

1400 SERIES EVIDENCE COLLECTION KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ESOPHAGEAL STETHOSCOPE

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Exofin Fusion Skin Closure System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Artix AX

FDA 510(k)

FDA Class 2 ·Cardiovascular

Zuno Smart Sterilization Container

FDA 510(k)

FDA Class 2 ·General Hospital

CLEANER ROTATIONAL THROMBECTOMY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MicrO2 OSA Device with Micro-Recorder

FDA 510(k)

FDA Class 2 ·Dental

CAPERE Thrombectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PHOT-X IIS MODEL 505

FDA 510(k)

FDA Class 2 ·Dental