72 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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810nm Diode Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304270862·
SILICONE MAT
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896019355·SILICONE MAT
C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG
FDA 510(k)
FDA Class 2
·Physical Medicine
HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041
FDA 510(k)
FDA Class 2
·Anesthesiology
ALINITY I FREE T4 REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CEC·April 28, 2026
ALINITY I FREE T4 REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CEC·February 4, 2026
ARCHITECT FREE T4
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CEC·May 12, 2026
ALINITY I FREE T4 REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CEC·May 18, 2026
ALINITY I FREE T4 REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CEC·April 16, 2026
ALINITY I FREE T4 REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CEC·September 2, 2025
HOSPITAL NON-VENTED FULL FACE MASK
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code CBK·April 5, 2017
ALINITY I FREE T4 REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CEC·April 1, 2026
ALINITY I FREE T4 REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CEC·February 4, 2026
ALINITY I FREE T4 REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CEC·March 25, 2026
ALINITY I FREE T4 REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CEC·March 30, 2026
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·October 17, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 21, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011
ARCHITECT FREE T4
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CEC·April 23, 2026