7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
DENTAL CHAIR
FDA 510(k)
FDA Class 1
·Dental
InvisionECG System
FDA 510(k)
FDA Class 2
·Cardiovascular
NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CORDLESS DRIVER 3
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HRX·June 2, 2014
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 15, 2012
PUMP MMT-723NAS PRDGM INSULIN SMOKE EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·September 21, 2010
PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·September 6, 2023