12 results
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26ms
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Sources: EU EUDAMED, US FDA
ARGYLE SUCTION CONTROL KIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Cardiovascular Procedure Kit
FDA UDI
Terumo Cardiovascular Systems Corporation·00699753534988·
Ortho Specialties
FDA UDI
Young Innovations, Inc.·00843471186688·Bicuspid Bands, Lower, Size 1
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110683·LUER ADAPTOR FOR IRRIGATION
REAL INTELLIGENCE CORI
FDA 510(k)
FDA Class 2
·Neurology
ARCH SUPPORT (ARCH AID)
FDA 510(k)DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NVY·July 8, 2022
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code KPE·September 26, 2012
SECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·December 19, 2013
TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·July 14, 2010
Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006 4. Allura Xper FD20 Biplane, Model Number 722008 5. Allura Xper FD10, Model Number 722010 6. Allura Xper FD10/10, Model Number 722011 7. Allura Xper FD20, Model Number 722012 8. Allura Xper FD20 Biplane, Model Number 722013 9. Allura Xper FD20 OR Table, Model Number 722023 10. Allura Xper FD10, Model Number 722026 11. Allura Xper FD10/10, Model Number 722027 12. Allura Xper FD20, Model Number 722028 13. Allura Xper FD20/10, Model Number 722029 14. Allura Xper FD20 OR Table, Model Number 722035 15. Allura Xper FD20/20, Model Number 722038 16. Allura Xper FD20/15, Model Number 722058 17. Allura Xper FD20/15 OR Table, Model Number 722059.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 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