19 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SURGICAL DYNAMICS MENISCAL STAPLE
FDA 510(k)
FDA Class 2
·Orthopedic
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450630334·
SIMPLY SPECS
FDA UDI
FGX INTERNATIONAL INC.·00193033522523·
SIMPLY SPECS
FDA UDI
FGX INTERNATIONAL INC.·00193033522516·
SIMPLY SPECS
FDA UDI
FGX INTERNATIONAL INC.·00193033522530·
VHF ULTRASONIC ARC-SCAN SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BD ULTRA-FINE II INSULIN SYRINGE-MINI NEEDLE, MODEL 30G * 3/16 (5MM)
FDA 510(k)
FDA Class 2
·General Hospital
AFX SYSTEM
FDA Adverse Event
Injury
·ENDOLOGIX, INC.·Product code MIH·March 20, 2013
QUICKFLEX XL LV LEAD
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·March 10, 2011
SWITCH-BLADE
FDA Adverse Event
Malfunction
·SNOWDEN-PENCER, INC.·Product code LRW·March 7, 2008
OPTILENE 6/0 (0,7) 75CM 2XDRC10 CV RCP
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAW·December 6, 2019
OPTILENE 6/0 (0,7) 45CM DS16 (M) RCP
FDA Adverse Event
Malfunction
·B/ BRAUN SURGICAL SA·Product code GAW·July 22, 2019
OPTILENE 6/0 (0,7) 45CM DS16 (M) RCP
FDA Adverse Event
Malfunction
·B/ BRAUN SURGICAL SA·Product code GAW·July 22, 2019
OPTILENE 6/0 (0,7) 45CM DS16 (M) RCP
FDA Adverse Event
Malfunction
·B/ BRAUN SURGICAL SA·Product code GAW·July 22, 2019
SAF-T-INTIMA IV CATHETER SAFETY SYSTEM WITH PRN ADAPTER
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·April 2, 2019
BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·May 2, 2019
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022
Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018