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

Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T

FDA 510(k)

FDA Class 2 ·Radiology

3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery