34 results
·
22ms
·
Sources: EU EUDAMED, US FDA
EXPLORER 4D TREATMENT PLANNING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Preat
FDA UDI
Preat Corporation·00842092108048·Preci Ball 22 Castable Male Only
Bur PM2-70 80K diam Ø1.8 St
FDA UDI
Bien-Air Surgery SA·17630055515794·
OneLIF™
FDA UDI
Novapproach Spine LLC·G07001321012200·Retention Plate, Anterior-Only, Medium, 12 mm -...
CARB-EDGE MAYO SCS 6-3/4 STR
FDA Adverse Event
Malfunction
·INTEGRA YORK, PA INC.·Product code LRW·November 26, 2018
ENDOPATH SURESEAL REDUCER CAP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 29, 2011
VAPR COOLPULSE90 ELECTRODE
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code GEI·October 2, 2020
CARB-EDGE MAYO SCS 6-3/4 STR
FDA Adverse Event
Malfunction
·INTEGRA YORK, PA INC.·Product code LRW·June 28, 2018
QUADRA ASSURA CRT-D, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 9, 2013
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 24, 2011
WALLSTENT ENTERNAL PROSTHESIS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MQR·January 9, 2023
AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code PCU·January 9, 2023
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·December 17, 2024
ADULT ET CLOSED SUCTION CATHETER
FDA Adverse Event
Malfunction
·FLEXICARE MEDICAL LTD·Product code BSY·September 23, 2025
ADULT INSPIRATORY-HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·April 6, 2011
VAPR TRIPOLAR 90 SUCTION ELECT
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code GEI·March 22, 2019
VAPR COOLPULSE 90 ELECTRODE, 90° SUCTION W/INTEGRATED HANDPIECE
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code GEI·October 16, 2019