78 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SunCHECK
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699595·GENUMEDI PSS BLUE, SIZE VII
INTEGRAL X-SERIES HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304182417·
Denovo Preformed Matrix Band
FDA UDI
Denovo Dental, Inc.·00810059290877·Denovo Preformed Matrix Band - Pediatric 3/16, ...
STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT
FDA 510(k)
FDA Class 2
·Dental
GELSCAN, MODEL 1206
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ALINITY I TOTAL B-HCG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 3, 2026
ALINITY I TOTAL B-HCG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 1, 2026
ALINITY I TOTAL B-HCG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 28, 2026
ALINITY I TOTAL B-HCG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 6, 2026
ALINITY I TOTAL B-HCG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·August 18, 2025
ALINITY I TOTAL B-HCG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 20, 2026
ALINITY I TOTAL B-HCG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·March 30, 2026
ALINITY I TOTAL B-HCG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 22, 2026
ALINITY I TOTAL B-HCG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 22, 2026
ALINITY I TOTAL B-HCG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 6, 2026
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·June 14, 2013
INSIGNIA
FDA Adverse Event
Malfunction
·GUIDANT CLONMEL IRELAND·Product code NVZ·July 20, 2011
MULLINS TRANSSEPTAL CATHETER INTRODUCER SET - 8F
FDA Adverse Event
Malfunction
·MEDTRONIC INC.·Product code DTB·September 12, 2008
ALINITY I TOTAL B-HCG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 29, 2026