15 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Mg-PSZ Ceramic Femoral Head
FDA 510(k)
FDA Class 2
·Orthopedic
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994203687·CASE 7220336 INSTRUMENT TRAY 1
Oticon
FDA UDI
Sbo Hearing A/S·05714464006472·MORE 2 FW 1.0.0
ELMED
FDA UDI
ELMED INCORPORATED·00842180135468·3 MM DIA., 33 CM INSULATED L-HOOK ELECTRODE, SI...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306824548·Walther Female Dilator-Catheters 13cm, 36Fr
ENDOSCOPIC CAMERA MC404/C3
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U
FDA 510(k)
FDA Class 1
·General Hospital
BD NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·May 14, 2026
SCREW DRIVER, HEX, 2.5MM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HSB·November 18, 2025
L-SHAPED HOOK SUCTION COAGULATOR, 5MM, 32CM
FDA Adverse Event
Malfunction
·TONTARRA MEDIZINTECHNIK GMBH·Product code KNS·November 3, 2008
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·August 23, 2011
FORTIFY VR, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2013
LAPIPLASTY SYSTEM S4A
FDA Adverse Event
Injury
·TREACE MEDICAL CONCEPTS, INC.·Product code HRS·March 14, 2025
Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table, Model Number: 722033. 6. Allura Xper FD20 OR Table, Model Number: 722035. 7. Allura Xper FD20/20, Model Number: 722038 8. Allura Xper FD20/20 OR Table, Model Number: 722039. 9. Allura Xper FD20/15, Model Number: 722058. 10. Allura Xper FD20/15 OR Table, Model Number: 722059.
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·June 30, 2025
Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table, Model Number: 722033. 6. Allura Xper FD20 OR Table, Model Number: 722035. 7. Allura Xper FD20/20, Model Number: 722038 8. Allura Xper FD20/20 OR Table, Model Number: 722039. 9. Allura Xper FD20/15, Model Number: 722058. 10. Allura Xper FD20/15 OR Table, Model Number: 722059.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·August 6, 2025