11 results · 28ms · Sources: EU EUDAMED, US FDA

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IV Administration

FDA 510(k)
FDA Class 2 ·General Hospital

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814190·GENUMEDI PT SILVER L II

ENDURAMESH

FDA 510(k)
FDA Class 2 ·Orthopedic

HANDHELD ECG MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code IOR·October 6, 2014

FLOGARD

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 3, 2013

CENTURY BED

FDA Adverse Event
Malfunction ·HILL-ROM INC.·Product code FNL·June 21, 2011

INFUSOMAT SPACE

FDA Adverse Event
Malfunction ·B.BRAUN MELSUNGEN AG·Product code FRN·September 1, 2022

SPYSCOPE DS II ACCESS & DELIVERY CATHETER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 30, 2020

SPYSCOPE DS II ACCESS & DELIVERY CATHETER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 23, 2020

PKG, DOLPHIN FORCEPS, SERRATED SPOON, P/N 0250080280. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·December 24, 2014