63 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ambar, Ambar APS, Ambar Universal APS
FDA 510(k)
FDA Class 2
·Dental
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304271074·
Vanguard Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304466067·
SAFIRE
FDA 510(k)
FDA Class 2
·Radiology
BUSSE SURGICAL DRAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·November 20, 2025
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 18, 2026
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 3, 2026
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·March 5, 2026
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·April 16, 2026
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·May 28, 2026
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·March 30, 2026
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·March 17, 2026
VANGUARD FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 8, 2018
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 18, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011
VANGUARD UNKNOWN KNEE PATELLA
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 9, 2018
VANGUARD CR ILOK FEMUR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 9, 2018
VANGUARD CR ILOK FEM-LT 62.5
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 9, 2018