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

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Device
EU MDR · Eu Md Class 2a ·Evidencio·On the market·1 country

SYPHILIS DETECTION BY NA REAGENTS

Device
EU IVDD · Eu Ivd General ·BioGX B.V.·On the market

TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23, 9311.23G01, 9311.23G02, 9311.23K01, 9311.23K02, 9311.23K03, 9623.G0201, 9623.G0202, 9623.K0201, 9311.23G01-00;

FDA Enforcement
Class II ·Ongoing·D.O.R.C. Dutch Opthalmic Research Center Intl B.V.·June 17, 2026

TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27G02, 9311.27K01, 9311.27K02, 9311.27K03, 9627.G0101, 9627.G0201, 9311.27G01-00;

FDA Enforcement
Class II ·Ongoing·D.O.R.C. Dutch Opthalmic Research Center Intl B.V.·June 17, 2026

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

TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;

FDA Enforcement
Class II ·Ongoing·D.O.R.C. Dutch Opthalmic Research Center Intl B.V.·June 17, 2026

ALLURA Xper FD10F; System Code: 722002;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

Allura Xper FD10C; System Code: 722001;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

Enterprise 1.5T, Model Number: 781145;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025

Intera 1.5T R11, Model Number: 781170;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025

Intera CV, Model Number: 781107;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025

Intera 0.5T Standard, Model Number: 781101;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025

Intera 1.5T Power/Pulsar, Model Number: 781105;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025

Intera 1.5T, Model Numbers: 781195 and 781295;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025

SmartPath to dStream for 1.5T, Model Number: 782146;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025

Intera 1.5T Master/Nova, Model Number: 781106;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025

Intera 1.0T Power/Pulsar, Model Number: 781103;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025

SmartPath to dStream for 3.0T, Model Number: 782145;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025

Intera 1.5T Omni/Stellar, Model Number: 781104;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025