V5med Lung AI

FDA 510(k)

FDA Class 2 ·Radiology

ORTHOCOR KNEE SYSTEM BASIC

FDA 510(k)

FDA Class 2 ·Physical Medicine

HANAROSTENT LowAx Colon/Rectum (NNN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LEGACY3 6MM LENGTH IMPLANTS

FDA 510(k)

FDA Class 2 ·Dental

INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

VENOTRAIN CURAFLOW

FDA 510(k)

FDA Class 2 ·General Hospital

STERILIZATION WRAP-STERISHEET

FDA 510(k)

FDA Class 2 ·General Hospital

TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT)

FDA 510(k)

FDA Class 2 ·Microbiology

Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system

FDA 510(k)

FDA Class 2 ·Cardiovascular

ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD

FDA 510(k)

FDA Class 2 ·Cardiovascular

WIRION Embolic Protection System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ViperCath XC Peripheral Exchange Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Diamondback 360 Peripheral Orbital Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series

FDA 510(k)

FDA Class 2 ·Cardiovascular

ViperCross Support Catheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ViperCross Support Catheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series

FDA 510(k)

FDA Class 2 ·Cardiovascular