14 results · 37ms · Sources: EU EUDAMED, US FDA

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CHILI PACS

FDA 510(k)
FDA Class 2 ·Radiology

INFINION CX

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 20, 2020

MAGIC MOBILITY 4 X 4 WHEELCHAIR

FDA 510(k)
FDA Class 2 ·Physical Medicine

AIA-PACK BRCA, ST AIA PACK BRCA

FDA 510(k)
FDA Class 2 ·Immunology

LINEAR ST

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 9, 2021

WAVEWRITER ALPHA?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 6, 2025

ADVISOR VITAL SIGNS MONITOR

FDA Adverse Event
Malfunction ·SMITHS MEDICAL PM, INC.·Product code CCK·December 24, 2008

ADVISOR VITAL SIGNS MONITOR

FDA Adverse Event
Malfunction ·SMITHS MEDICAL PM, INC·Product code DQK·April 28, 2010

PRECISION®

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 22, 2013

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 9, 2008

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 14, 2011

Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

FDA Enforcement
Class II ·Terminated·Stryker GmbH·June 24, 2020

Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024