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QMAPP System cable-White (1000cm) 1 zijdig ODU Connector, 1 zijdig CPU termination

Device
EU MDR · Eu Md Class 1 ·Fysicon B.V.·On the market

Emergo Europe B.V.

Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices

MedEnvoy Global BV

Importer
🇳🇱 Netherlands·234 Manufacturers

708033 URODiagnost As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems Nederlands·May 9, 2018

MultiDiagnost Eleva 708036 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems Nederlands·May 9, 2018

Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integris Allura 15 & 12 (monoplane) (722043), INTEGRIS Allura 15-12 (biplane) (722044), Integris-Allura 9 (722018), Integris-Allura 9 (Biplane) (722021), Integris CV Cesar-Powerpack (722030), Integris H5000 C / Allura 9C (722016);

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026

MultiDiagnostic-Eleva with Flat Detector 708035 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems Nederlands·May 9, 2018

MultiDim Eleva 708032 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems Nederlands·May 9, 2018

MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems Nederlands·May 9, 2018

Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems Nederlands·May 9, 2018

Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems Nederlands·May 9, 2018

OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025

FDA Enforcement
Class II ·Terminated·Philips Medical Systems Nederlands·July 4, 2018

OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028

FDA Enforcement
Class II ·Terminated·Philips Medical Systems Nederlands·July 4, 2018

Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026

Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 722229. 2. Azurion 3 M15; Model Numbers: 722222, 722064, 722280, 722230. 3. Azurion 5 M12; Model Numbers: 722227, 722231. 4. Azurion 5 M20; Model Numbers: 722228, 722232, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225, 722235. 6. Azurion 7 B20; Model Numbers: 722068, 722226, 722236. 7. Azurion 7 M12; Model Numbers: 722078, 722223, 722233. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 722234, 722282.

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026

SUNGO Europe B.V.

Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices

Kingsmead Service B.V.

Authorized representative
🇳🇱 Netherlands·243 Manufacturers·2698 Devices