32 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327090123·Blade F. 6514-7-200, 2.0/2.3mm MP
CultureSwab
FDA UDI
COPAN ITALIA SPA·38053326002121·141CQ TRANS.LQ STUART CultureSwab Polyester Liq...
Adler Instrument Company
FDA UDI
Adler, Inc.·00810123205745·Olsen Webster Needle Holder TC, Smooth Jaws TW ...
Optimotion Implants Porous Metal-Backed Patella
FDA 510(k)
FDA Class 2
·Orthopedic
SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA
FDA 510(k)
FDA Class 2
·General Hospital
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 20, 2014
ALINITY I CMV IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·April 28, 2026
ALINITY I CMV IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·May 4, 2026
HOMECHOICE
FDA Adverse Event
Death
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 3, 2014
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 15, 2011
QUADRA ASSURA CRT-D
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013
ALINITY I CMV IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·April 2, 2026
ALINITY I CMV IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·April 30, 2025
ALINITY I CMV IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·March 17, 2026
ALINITY I CMV IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·March 17, 2026
ALINITY I CMV IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·November 3, 2025
ALINITY I CMV IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·May 21, 2025
ARCHITECT CMV IGG
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·February 19, 2026
ALINITY I CMV IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFZ·July 14, 2025