22 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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S.I.N. Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391
FDA 510(k)
FDA Class 2
·General Hospital
SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRB·January 8, 2021
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 14, 2014
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code LKK·June 14, 2013
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 20, 2011
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
KIT BD MAX EXT ENTERIC BACTERIAL PANEL
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·June 21, 2022
BINAXNOW COVID-19 ANTIGEN SELF TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 4, 2022
BINAXNOW COVID-19 ANTIGEN SELF TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 4, 2022
LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DQX·August 14, 2024
LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
FDA Adverse Event
Death
·COOK VANDERGRIFT INC·Product code DRB·August 23, 2024
LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DQX·August 23, 2024
LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRB·February 12, 2024
LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRB·March 13, 2024
LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DQX·November 8, 2024
LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRB·February 12, 2024
LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DQX·October 25, 2024