37 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SIGNA Artist
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
Synthes GmbH·10886982144102·2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE ...
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113257·VITRECTOMY KNIFE 25GA (BX/5)
MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626
FDA 510(k)
FDA Class 1
·Cardiovascular
CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
Chord-X Premeasured Loops and Suture System
FDA UDI
ON-X LIFE TECHNOLOGIES, INC.·00813570020091·Artificial chordal replacement prosthesis
Chord-X Premeasured Loops and Suture System
FDA UDI
ON-X LIFE TECHNOLOGIES, INC.·00813570020053·Artificial chordal replacement prosthesis
Chord-X Premeasured Loops and Suture System
FDA UDI
ON-X LIFE TECHNOLOGIES, INC.·00813570020060·Artificial chordal replacement prosthesis
Chord-X Premeasured Loops and Suture System
FDA UDI
ON-X LIFE TECHNOLOGIES, INC.·00813570020077·Artificial chordal replacement prosthesis
Chord-X Premeasured Loops and Suture System
FDA UDI
ON-X LIFE TECHNOLOGIES, INC.·00813570020084·Artificial chordal replacement prosthesis
ACCU-CHEK ® PERFORMA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE, INC.·Product code NBW·January 10, 2023
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020
MELODY TRANSCATHETER PULMONARY VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPV·May 20, 2022
REGENCY SR+
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code LWP·January 13, 2014
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·June 28, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
MICRA
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code PNJ·February 21, 2023
REVEAL LINQ
FDA Adverse Event
Malfunction
·MEDTRONIC SINGAPORE OPERATIONS·Product code DSI·May 1, 2023
MEDTRONIC ICD
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DXY·October 17, 2022
THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·October 14, 2022