164 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

ELDONBOX 2521 ID-25

Device
EU IVDD · Eu Ivd Annex 2 List A ·Eldon Biologicals A/S·On the market

ELDONBOX 2521 ID-100

Device
EU IVDD · Eu Ivd Annex 2 List A ·Eldon Biologicals A/S·On the market

ELDON BAG 2521 ID-10

Device
EU IVDD · Eu Ivd Annex 2 List A ·Eldon Biologicals A/S·On the market

POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102

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

POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101

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

POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID

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

ELDONBOX 2521 ID-100

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Eldon Biologicals A/S·1 device

ELDON BAG 2521 ID-10

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Eldon Biologicals A/S·1 device

ELDON BAG 2521 ID-25

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Eldon Biologicals A/S·1 device

ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

FDA Enforcement
Class II ·Terminated·Radiometer Medical ApS·July 8, 2020

ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

FDA Enforcement
Class II ·Terminated·Radiometer Medical ApS·July 8, 2020

ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

FDA Enforcement
Class II ·Terminated·Radiometer Medical ApS·April 29, 2020

ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

FDA Enforcement
Class II ·Terminated·Radiometer Medical ApS·April 29, 2020

ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) In vitro testing of samples of expired air for the parameters pO2 and pCO2 In vitro testing of pleura samples for the pH parameter.0693938004 and 393-801/05700693938011 - Product Usage:

FDA Enforcement
Class II ·Terminated·Radiometer Medical ApS·April 15, 2020

Cardia International A/S

Manufacturer
🇩🇰 Denmark·5 Basic UDI-DIs·5 Devices·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.

EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS

Device
EU MDD · Eu Md Class 2b ·Cardia International A/S·On the market·1 country

EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS

Device
EU MDD · Eu Md Class 2b ·Cardia International A/S·On the market·1 country

CardiAid®

Device
EU MDD · Eu Md Class 2b ·Cardia International A/S·On the market·2 countries

BLOSTRUPMOEN®

Device
EU MDD · Eu Md Class 2b ·Cardia International A/S·On the market·1 country

CardiAid®

Device
EU MDD · Eu Md Class 2b ·Cardia International A/S·On the market·2 countries