16 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx
FDA 510(k)
FDA Class 2
·Physical Medicine
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486003524·MCK FEMORAL TRIAL (SIZE 7 LM/RL)
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551058299·TRAUTMANN Mastoid Gouge, 14 cm
LEONE SPA
FDA UDI
LEONE SPA·08033707018698·CALIBRA 1ST MOLAR BANDS n.LL 7
XRES BLOOD COLLECTION RESERVOIR
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO: LIGAFIX INTERFERENCE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
VIDAS® TOXO IGM
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LYR·December 7, 2016
VIDAS® TOXO IGM
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LYR·December 5, 2016
STAR TOTAL ANKLE REPLACEMENT
FDA Adverse Event
Injury
·SMALL BONE INNOVATIONS, INC.·Product code NTG·October 9, 2014
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 24, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 21, 2011
COBAS® MPX - 480T
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 26, 2025
T-HANDLE INSERTER
FDA Adverse Event
Malfunction
·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code MAX·April 29, 2021
T-HANDLE
FDA Adverse Event
Malfunction
·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code LXH·May 2, 2023
IMPLANT INSERTER SH CONNECTION
FDA Adverse Event
Malfunction
·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code MAX·May 2, 2023
COBAS® MPX - 480T
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 24, 2025