74 results · 22ms · Sources: EU EUDAMED, 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