10 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Curapuls 670
FDA 510(k)
FDA Class 2
·Physical Medicine
ELMED
FDA UDI
ELMED INCORPORATED·00842180186378·Irrigation/injection needles. Olive tip. Overal...
Vu a-POD™
FDA UDI
Seaspine Orthopedics Corporation·10889981042035·31x24mm Trial Rasp 12mm 12 deg
Disposable Medical Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PCA II PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code MEA·November 21, 2008
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
HUDSON CONCHA NEPTUNE
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTT·July 18, 2013
EVOLUT R TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·February 9, 2026
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025