79 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARIX Ankle Distal Tibia System
FDA 510(k)
FDA Class 2
·Orthopedic
INTEGRAL X-SERIES HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304182479·
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10887488266817·L AND D BLANKET KIT
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100868·MCNEILL GLOBAL FIXATION RING LARGE
Denovo Preformed Matrix Band
FDA UDI
Denovo Dental, Inc.·00810059290938·Denovo Preformed Matrix Band - Pediatric 3/16, ...
INTEGRAL X-SERIES HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304182189·
MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
HYDROFIX SURGICAL SHEET
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 14, 2014
SWEET TIP
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 20, 2011