11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Oragene Dx
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106372·HELVESTON FIXATION FORCEPS WITH LOCK
Monoblock Ball Joint Driver
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215076214·
VOLPARA, VERSION 1.3
FDA 510(k)
FDA Class 2
·Radiology
CG-7000DX-BT ECG RECORDER/TRANSMITTER
FDA 510(k)
FDA Class 2
·Cardiovascular
CLIP, IMPLANTABLE, REPROCESSED
FDA Adverse Event
Malfunction
·STERILMED, INC.·Product code NMJ·October 6, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC SINGAPORE OPERATIONS·Product code DTB·June 7, 2013
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 27, 2011
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017