46 results
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20ms
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Sources: EU EUDAMED, US FDA
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Country: Netherlands
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OPEN BORE SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
Philips CT Big Bore
Device
EU MDR
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Eu Md Class 2b
·Philips Medical Systems Nederland B.V.·On the market·1 country
Philips CT Big Bore System
Basic UDI-DI
EU MDR
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Eu Md Class 2b
·Philips Medical Systems Nederland B.V.·1 device
W.L. Gore & Associates B.V.
Importer
🇳🇱 Netherlands·1 Manufacturer
Core Products International BV
Authorized representative
🇳🇱 Netherlands
W.L. Gore & Associates B.V.
Authorized representative
🇳🇱 Netherlands·1 Manufacturer
How Are You Diagnostics B.V.
Authorized representative
🇳🇱 Netherlands
How Are You Diagnostics B.V.
System producer
🇳🇱 Netherlands
OmniMedical B.V.
Importer
🇳🇱 Netherlands·5 Manufacturers
QNET B.V.
Authorized representative
🇳🇱 Netherlands·33 Manufacturers·364 Devices
Dayes Europe B.V.
Importer
🇳🇱 Netherlands·8 Manufacturers
Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
FDA Enforcement
Class II
·Ongoing·Kreatech Biotechnology Bv·December 4, 2024
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·April 24, 2019
Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as a diagnostic device. The purpose of the MED is to supply power to charge the magnet. MED is abbreviation for Magnet Energize Device
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·May 8, 2019
Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use
FDA Enforcement
Class II
·Terminated·Vital Scientific N.V.·October 23, 2019
Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
FDA Enforcement
Class II
·Terminated·Vital Scientific N.V.·October 23, 2019
Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
FDA Enforcement
Class II
·Terminated·Vital Scientific N.V.·October 23, 2019
V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use
FDA Enforcement
Class II
·Terminated·Vital Scientific N.V.·October 23, 2019
V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
FDA Enforcement
Class II
·Ongoing·Vital Scientific N.V.·October 2, 2019
SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 26, 2023