18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CarpX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Olympus
FDA UDI
Gyrus ACMI, LLC·00821925045941·nCare 4K 21.5" Medical Touch Panel
ACUMED
FDA UDI
Acumed LLC·10806378014529·2.7mm x 18.0mm Locking Cortical Screw
ACUMED
FDA UDI
Acumed LLC·10806378014536·2.7mm x 18.0mm Locking Cortical Screw
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Non-contact Infrared Body Thermometer, model:HTD8823US
FDA 510(k)
FDA Class 2
·General Hospital
COCR HEAD 28/+4 'L' 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code MEH·January 26, 2026
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 24, 2014
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
RESERVOIR 3ML
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 1, 2013
PATIENT INTERFACE NIM4CPB1 NIM 4.0
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·October 28, 2025
PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·September 26, 2024
STIMULATOR, ELECTRICAL, EVOKED RESPONSE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·July 31, 2023
NIM 4.0 CONSOLE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·September 5, 2025
NIM 4.0 CONSOLE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·August 2, 2024
NIM 4.0 CONSOLE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·May 20, 2025
MECTALIF TRANSFORAMINAL CAGES TIPEEK
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code MAX·April 25, 2025
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021