35 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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L10 LED Light Source with AIM, L11 LED Light Source with AIM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Obturator
FDA UDI
SOPRO-COMEG GmbH·04059082032856·
STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
CORIN MINIHIP FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 19, 2020
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·June 21, 2013
HS HAND CONTROLLED CURVED SHEAR
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GEI·October 9, 2008
JAGWIRE¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA·Product code EZB·August 4, 2011
ELECTRONIC GAS BLENDER
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTX·November 19, 2025
STOCKERT S3 GAS BLENDER
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·December 22, 2014
Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 874T, 876, 876T, 884, 886, 886T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
S3 GAS BLENDER SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTX·October 16, 2017
S3 GAS BLENDER SYSTEM
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTX·October 16, 2017
S3 ELECTRONIC GAS BLENDER
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DTX·December 19, 2024
SORIN S3 GAS BLENDER
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTX·February 25, 2015
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code FDI·December 2, 2020
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code FDI·October 23, 2020
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code FDI·December 2, 2020
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code FDI·November 30, 2020
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code FDI·December 11, 2020