REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

RE-SHARPENABLE SAW BLADES

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS

FDA 510(k)

FDA Class 2 ·Cardiovascular

REPROCESSED DISPOSABLE TROCARS

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP

FDA 510(k)

FDA Class 2 ·Cardiovascular

Kryptonite Solutions

Manufacturer

🇮🇳 India·3 Basic UDI-DIs·3 Devices

WELT Corp.

Manufacturer

🇰🇷 South Korea·1 Basic UDI-DI·1 Device

Lunit Inc.

Manufacturer

🇰🇷 South Korea·2 Basic UDI-DIs·5 Devices·3 Importers

Kryptonite Solutions

Device

EU MDR · Eu Md Class 1 ·Kryptonite Solutions·On the market

Kryptonite Solutions

Device

EU MDR · Eu Md Class 1 ·Kryptonite Solutions·No longer on the market

Kryptonite Solutions

Device

EU MDR · Eu Md Class 1 ·Kryptonite Solutions·No longer on the market

WELT-i-A

Device

EU MDR · Eu Md Class 1 ·WELT Corp.·On the market

Lunit INSIGHT DBT

Device

EU MDR · Eu Md Class 2a ·Lunit Inc.·On the market·27 countries

Lunit INSIGHT DBT

Device

EU MDR · Eu Md Class 2a ·Lunit Inc.·On the market·20 countries

Lunit INSIGHT CXR

Device

EU MDR · Eu Md Class 2a ·Lunit Inc.·On the market·20 countries

Lunit INSIGHT CXR

Device

EU MDR · Eu Md Class 2a ·Lunit Inc.·On the market·30 countries

Lunit INSIGHT MMG

Device

EU MDR · Eu Md Class 2a ·Lunit Inc.·On the market·30 countries

AURA Medical s.r.o.

Importer

🇨🇿 Czechia·2 Manufacturers

In-Bore MRI cinema

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Kryptonite Solutions·1 device