9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
STRYKER AMBULANCE COT MODEL 6060
FDA 510(k)
FDA Class 2
·General Hospital
DIAVENTIONAL CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
TROCAR & TROCAR SLEEEVE 11MM, 10MM, 8MM & 5MM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HOPKINS TELESCOPE 0°, 5 MM, 29 CM
FDA Adverse Event
Malfunction
·KARL STORZ SE & CO. KG·Product code GCJ·May 16, 2025
AUTOPULSE NIMH BATTERY
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·January 25, 2013
MODULAR ANALYTICS CORE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·December 22, 2010
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 15, 2014
ASTROGLIDE
FDA Adverse Event
Malfunction
·COMBE INC·Product code KMJ·January 16, 2024
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