2,581 results · 39ms · Sources: EU EUDAMED, US FDA

EleGARD

FDA 510(k)
FDA Class 1 ·General Hospital

ECA

FDA 510(k)
FDA Class 1 ·General Hospital

TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

EleGARD Patient Positioning System

FDA 510(k)
FDA Class 1 ·General Hospital

ZoomCam

Basic UDI-DI
EU MDR · Eu Md Class 1 ·KOBA Vision·2 devices

EasyReader

Basic UDI-DI
EU MDR · Eu Md Class 1 ·KOBA Vision·6 devices

Vocatex

Basic UDI-DI
EU MDR · Eu Md Class 1 ·KOBA Vision·19 devices

KAY-PLUS & VARIOUS VANIA SANITARY LINERS & PADS

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Evidence MultiSTAT Drugs of Abuse (DOA) ToxPlex Urine Array

Device
EU IVDR · Eu Ivd Class C ·Randox Laboratories Limited·On the market·1 country

Melanoma Associated Antigen; Clone KBA.62 (Concentrate) 1 mL

Device
EU IVDR · Eu Ivd Class C ·ScyTek Laboratories Inc.·On the market·1 country

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·MEDTONIC FREESTYLE AORTIC BIOPROSTHESIS

DENTMATE TECHNOLOGY

Manufacturer
🇹🇼 Taiwan·2 Importers

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC MODELS 8616-10 & 8617-10(ALSO REFERRED TO AS MODELS 8631 & 8635) SYNCHROMED(R) IMPLANT.PROGRAM. INFUSION PUMP

Pack, hot or cold, reusable

FDA registration
SOUTH SOURCE HEALTH TECHNOLOGY (CAMBODIA) CO., LTD.·1 product·🇰🇭 Cambodia

PAD, HEATING, POWERED

FDA registration
SOUTH SOURCE HEALTH TECHNOLOGY (CAMBODIA) CO., LTD.·1 product·🇰🇭 Cambodia

MYHIXEL Ring

FDA registration
DAKA INTERNATIONAL LIMITED·1 product·🇨🇳 China

Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL)

FDA 510(k)
FDA Class 1 ·General Hospital

NIL

FDA 510(k)
FDA Class 1 ·Ophthalmic

Anti-Coa, for card method Coombs-reactive, polyclonal, human IgG

Device
EU IVDR · Eu Ivd Class C ·ANTITOXIN GmbH·On the market·2 countries

Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology