13 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Electric wheelchair (KR-8807)
FDA 510(k)
FDA Class 2
·Physical Medicine
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383553575·"An absorbent paper points is an endodontic pap...
INSTANT-X, MODELS 1713 & 128
FDA 510(k)
FDA Class 2
·Radiology
Spectra Soft Tissue Biopsy Needles
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DELTA CER HEAD 12/14 36MM +8.5
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code LZO·May 11, 2020
BD SYRINGE 3ML LL W/NDL 18X1-1/2 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·April 16, 2025
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014
RIATA PASSIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011
POWER PICC SOLO CATHETER WITH SHERLOCK 3CG
FDA Adverse Event
Injury
·BARD ACCESS SYSTEM·Product code LJS·July 18, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025