12 results · 26ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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