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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

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

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

Kingsmead Service B.V.

Authorized representative
🇳🇱 Netherlands·243 Manufacturers·2698 Devices

SUNGO Europe B.V.

Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices

Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY).

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

Allura Xper FD20/10; Catalog numbers: 722029

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

Allura Xper FD10C; Catalog number: 722001

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to raise the temperature of the thoracic or peritoneal cavity to a target temperature.

FDA Enforcement
Class I ·Terminated·Eight Medical International BV·August 4, 2021

Allura CV20; Catalog numbers: 722031

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025