Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitaxe

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT Admiral DCB Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·TESLACON(TM) NMR IMAGING SYSTEM

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·THE HORIZON SYSTEM

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·CORDIS PROGRAMMABLE NEURAL STIMULATOR MODELS 900A,

BOUTIQUE PRO MEDICAL

Authorized representative

🇫🇷 France

Jazz Pharmaceuticals PLC

Authorized representative

🇮🇪 Ireland·1 Manufacturer

Chemical Works of Gedeon Richter Plc.

Importer

🇭🇺 Hungary

7074GB410200529

Certificate

MDD Annex II (excluding section 4)·Shenzhen PRO HITU Medical Co., Ltd.·DNV MEDCERT GmbH·1 Basic UDI-DI

3M Deutschland GmbH (Medical)

Authorized representative

🇩🇪 Germany·3 Manufacturers

TransMedica s.r.o.

Importer

🇸🇰 Slovakia·1 Manufacturer

Kimal Sarl

Importer

🇫🇷 France·1 Manufacturer

Kapamed International SRL

Importer

🇷🇴 Romania·1 Manufacturer

Kyslík pro život, s.r.o.

Authorized representative

🇨🇿 Czechia·1 Manufacturer·1 Device

Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate

FDA 510(k)

FDA Class 1 ·General Hospital

Mego Pro s.r.o.

System producer

🇨🇿 Czechia

BOUTIQUE PRO MEDICAL

System producer

🇫🇷 France

Pierced Ear/Entry Cleaning Tray

FDA classification

FDA Class 1 ·Pierced Ear/Entry Cleaning Tray

N LATEX STFR REAGENT

FDA 510(k)

FDA Class 2 ·Immunology