71 results · 22ms · Sources: EU EUDAMED, US FDA

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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