12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Intense Pulse Light Therapeutic Apparatus
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ABT12 multi-purpose solution
FDA 510(k)
FDA Class 2
·Ophthalmic
DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·July 31, 2019
ALINITY I TOXO IGM REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·April 22, 2026
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·September 27, 2023
XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·November 6, 2014
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·July 22, 2011
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code FNL·July 18, 2013
TRULIANT TIB IMP PS INSERT SZ 3.5 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 9, 2024
ALINITY I TOXO IGM REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·June 2, 2025
ALINITY I TOXO IGM REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·September 11, 2025