12 results
·
33ms
·
Sources: EU EUDAMED, US FDA
Volta AF-Xplorer
FDA 510(k)
FDA Class 2
·Cardiovascular
Oxyfit Pulse Oximeter
FDA 510(k)
FDA Class 2
·Cardiovascular
PALACOS MV pro
FDA 510(k)
FDA Class 2
·Orthopedic
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
UNKNOWN BD SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·May 5, 2025
ONE TOUCH ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·November 24, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 12, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 23, 2013
BD INTIMA-II 24GAX0.75IN PRN SLM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·May 13, 2025
BD INTIMA-II 24GAX0.75IN PRN SLM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·May 28, 2025
PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080234. 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
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025