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

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Laser Peripherals, LLC Family of Bare Laser Fibers

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

SYNGO.CT CARDIAC FUNCTION

FDA 510(k)
FDA Class 2 ·Radiology

MEDICINA ENTERAL FEEDING TUBES AND ACCESSORIES MODEL MGX/YY

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

LINEAR 3-6

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 4, 2020

LINEAR 3-6

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 15, 2020

FINELINE II

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVN·July 20, 2011

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·May 24, 2013

TS FLEX ARTICNG LNR CUTR 45MM

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 12, 2008

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

DENALI JUGULAR SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 27, 2023

DENALI JUGULAR SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·November 21, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 10, 2023

ALINITY C PROCESSING MODULE

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JJE·April 3, 2025

DENALI FEMORAL SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 6, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 20, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 11, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·November 7, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·October 20, 2023

DENALI FEMORAL SYSTEM

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 9, 2023