8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
S21 OTC Transcutaneous Electrical Nerve Stimulator
FDA 510(k)
FDA Class 2
·Neurology
andorate Suction Valve, andorate Air/Water Valve
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SMOKE EVACUATION ATTACHEMENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 18, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011
UV FLASH TRANSFER SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 18, 2013
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025