12 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Teleflex Rusch SoftSimplastic Foley Catheters
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112625·BARRON CORNEAL PUNCH 7.75MM
HBIDB - HUMAN BRIAN INDEX SOFTWARE
FDA 510(k)
FDA Class 2
·Neurology
IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6
FDA 510(k)
FDA Class 2
·Microbiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 6, 2025
CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·October 23, 2008
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 15, 2011
IMMULITE 2000 PROSTATE SPECIFIC ANTIGEN
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code MTF·July 8, 2013
OPTETRAK LOGIC
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 6, 2019
CEFALY
FDA Adverse Event
Injury
·CEFALY TECHNOLOGY·Product code PCC·March 9, 2026
CEFALY
FDA Adverse Event
Injury
·CEFALY TECHNOLOGY·Product code PCC·March 9, 2026
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025