14 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Passeo-14 Peripheral Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741522400·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674152240060·
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192121·Apex Revision Knee Reamer – ZIMMER SHORT FLUTES...
Acetabular Reamer 40 mm
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215098797·
RADIFOCUS GLIDEWIRE M
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 22, 2018
NIVO NEBULIZER SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002
FDA 510(k)
FDA Class 2
·Cardiovascular
BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 6, 2021
INRATIO PT/INR TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·October 3, 2014
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·June 7, 2013
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 23, 2011
Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023