71 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
QUADROSTARPROGREEN, QUADROSTARPROYELLOW
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD ULTRA FINE PEN NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·May 17, 2021
REDONDO-L
FDA 510(k)
FDA Class 2
·Orthopedic
ZAP HCG TEST, MODEL 8001
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PEN NDL 32G 4MM HP 100 BOX 1200 US
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·March 29, 2021
INFLATOR KIT 18INFKIT BALLOON
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code LRC·August 15, 2014
PEN NDL 32G 4MM HP
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·May 24, 2021
PEN NDL 32G 4MM HP 100 BOX 1200 US
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 8, 2021
BALLOON SEEKER
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code LRC·August 15, 2014
EXCLAIM 8
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 20, 2013
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 1, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 12, 2011
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
Allura Xper FD20/10; Model Numbers: 722029; 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
Cardio Vascular-Allura Centron; Model Numbers: 722400; 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 FD10 OR Table; Model Numbers: 722033; 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