13 results
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18ms
·
Sources: EU EUDAMED, US FDA
HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ZAVATION
FDA UDI
Zavation LLC·00842166191808·Anti-Torque Posterior Cervical Reduction Screw
Xcaliber External Fixator
FDA UDI
ORTHOFIX SRL·18032568863345·XCALIBER ARTICULATED ANKLE KIT STERILE
NEONATE ARRAY COILS
FDA 510(k)
FDA Class 2
·Radiology
ADI TiDAL Osteotomy Wedge
FDA 510(k)
FDA Class 2
·Orthopedic
ARCTIC FRONT CARDIAC CRYOABLATION CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC CRYOCATH LP·Product code DRA·March 3, 2016
INSERT, BIPOLAR FORCEPS
FDA Adverse Event
Malfunction
·RICHARD WOLF MEDICAL INSTRUMENTS CORP.·Product code GEI·April 2, 2015
XCALIBER ARTICULATED ANKLE KIT STERILE
FDA Adverse Event
Malfunction
·ORTHOFIX SRL·Product code JDW·July 11, 2012
XCALIBER ARTICULATED ANKLE KIT STERILE
FDA Adverse Event
Malfunction
·ORTHOFIX SRL·Product code JDW·December 18, 2013
ASR UNI FEMORAL IMPL SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·March 6, 2013
CONSULTA
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·February 15, 2011
ADVISA DR MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code NVZ·August 8, 2014
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Azurion 7 B20, Model Number 722068. 5. Azurion 7 M12, Model Number 722078. 6. Azurion 7 M20, Model Number 722079. 7. Azurion 3 M12, Model Number 722221. 8. Azurion 3 M15, Model Number 722222. 9. Azurion 7 M12, Model Number 722223. 10. Azurion 7 M20, Model Number 722224. 11. Azurion 7 B12, Model Number 722225. 12. Azurion 7 B20, Model Number 722226. 13. Azurion 5 M12, Model Number 722227. 14. Azurion 5 M20, Model Number 722228. 15. Azurion 7 M20, Model Number 722282.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025