12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XN CAL PF
FDA 510(k)
FDA Class 2
·Hematology
EBERLE
FDA UDI
Eberle GmbH & Co. KG·04050052016067·Oval Burr 5,5
ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058
FDA 510(k)
FDA Class 2
·Cardiovascular
GEMINI PET/CT IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PLEURX LOCKABLE DRAINAGE LINE SET
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·April 2, 2026
TSS PRESS FIT STEM SZ. 10
FDA Adverse Event
Malfunction
·ASCENSION ORTHOPEDICS·Product code KWS·September 28, 2018
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 2011
PLEURX
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·September 26, 2025
PLEURX
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·June 2, 2025
ProScreen 6 Panel Dip Card, Item No. PSCuPSD-6BUP300, PSD-6MTDBO300, PSD-6BUPO, PSD-6MBO, PSD-6MB,
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015