25 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack
FDA 510(k)
FDA Class 2
·Microbiology
K152468
FDA UDI
Shenzhen Vistar Medical Supplies Co.,Ltd.·96973521874184·Reusable NIBP cuff,Thigh,single tube, HP connector
CoRoent
FDA UDI
Nuvasive, Inc.·00887517575470·CoRoent Ant TLIF Ti, 15x12x40mm 8°
DIGITAL DIAGNOSTIC X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
EZ-IO
FDA 510(k)
FDA Class 2
·General Hospital
STINGRAY LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·March 26, 2025
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 13, 2025
STINGRAY? LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·May 29, 2026
OPTIPAC 60 REFOB BONE CMT R-3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LOD·May 11, 2026
SHUNT SENSOR SYS500
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DRY·October 3, 2014
SPRINT QUATTRO
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 7, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 28, 2011
BIOMET BONE CMENT R 1X40 JP
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code LOD·May 22, 2025
REFOBACIN BONE CEMENT R 1X40-3
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code LOD·June 18, 2025
OPTIPAC 80 BIOMET BC R
FDA Adverse Event
Death
·BIOMET FRANCE S.A.R.L.·Product code LOD·April 9, 2026
BIOMET BONE CEMENT R 40 -3
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code LOD·July 31, 2025
BIOMET BONE CMENT R 1X40 JP
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code LOD·June 17, 2025
OPTIPAC 60 REFOB BONE CMT R-3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LOD·February 5, 2025
OPTIPAC 60 REFOB BONE CMT R-3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LOD·February 5, 2025
BIOMET BONE CMENT R 1X40 JP
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LOD·October 8, 2025