30 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO RAICHEM CALCIUM REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Safco T&F Bur - 12 Bladed
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310220493·Safco T&F bur - 12 bladed, carbide, #7214 taper...
LINK Instruments - Trial implants and size gauges
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575408993·Acetabulum prosthesis trial, reusable - Vario-C...
INVERNESS MEDICAL EARLY PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FORTAFLEX SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HEARTWARE HVAD
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·March 26, 2013
EYE SURGERY STRETCHER OBS
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·March 10, 2011
BIOFLEX TESIO CATH
FDA Adverse Event
Malfunction
·MEDCOMP·Product code MSD·March 28, 2008
Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24
FDA Enforcement
Class II
·Ongoing·ICU Medical Inc.·September 10, 2025
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·December 22, 2011
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER INC.·Product code MMI·December 20, 2011
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·December 22, 2011
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·December 22, 2011
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code MMI·December 22, 2011
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·December 22, 2011
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code MMI·December 22, 2011
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·December 22, 2011
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code MMI·December 22, 2011
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·December 22, 2011
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code MMI·December 22, 2011