13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC
FDA 510(k)
FDA Class 2
·Radiology
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973097·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172971215·
MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
QUICK CHECK ONE
FDA Adverse Event
DIAGNOSTIC SOLUTIONS, INC.·Product code CFR·April 24, 1997
ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
FDA Adverse Event
Malfunction
·ANGIOSCORE, INC·Product code LIT·November 18, 2015
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·May 21, 2013
0.8% SURGISCREEN
FDA Adverse Event
Injury
·ORTHO CLINICAL DIAGNOSTICS·Product code KSZ·June 13, 2011
RSVR MMT-326A 10PK PRDGM 1.8ML 13L
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FMF·August 15, 2008
VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Co. Inc.·December 29, 2021
SOMATOM Edge Plus-Computed tomography system Model 1026700
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022
DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractures, Ipsilateral neck/shaft fractures, Femoral shaft fractures, Impending pathologic fractures, and malunions/Non-unions.
FDA Recall
Terminated
·Synthes, Inc.·Product code HSB·May 27, 2015