74 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FIRSTSTIC N INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
BANANA KNIFE - K841969-LABELING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CAMELBACK HANDLE-K841969-LABELING
FDA 510(k)
FDA Class 1
·Orthopedic
2.5MM & 4MM PROBE K841969-LABELING
FDA 510(k)
FDA Class 1
·Orthopedic
MH1 MICROHOLTER RECORDER
FDA 510(k)
FDA Class 2
·Cardiovascular
AURORA DS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PEN NEEDLE AUTOSHIELD DUO 30GX5MM USA
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·September 22, 2020
ANN BLUNT TIP SCREW
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code HSB·November 10, 2023
PLEURX LOCKABLE DRAINAGE LINE SET
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·April 2, 2026
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 2011
PLEURX
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·September 26, 2025
ANN BLUNT TIP SCREW 4X40MM
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code HSB·August 21, 2024
PLEURX
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·June 2, 2025
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025