15 results · 26ms · Sources: EU EUDAMED, 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