27 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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US SYSTEM
FDA 510(k)
FDA Class 2
·Dental
RN Octagonimpression cap, screwed built-in handle
FDA UDI
BIO CONCEPT Co., Ltd.·06947600302155·
OMNIBotics
FDA UDI
Omni Life Science, Inc.·00841690195368·3.5mm Hex Driver
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L062030120·6mm H x 20mm W x 30mm L XLIF Trial 12 degree Lo...
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0620000·Universal Removal Set
PORTABLE INTENSIVE CARE UNIT
FDA 510(k)
FDA Class 3
·Cardiovascular
OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·VANTIVE US HEALTHCARE LLC·Product code FKX·April 15, 2026
DEXCOM ONE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 14, 2025
BD SYRINGE 20ML LL 120/PKG
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 23, 2026
BD SYRINGE 20ML LL 120/PKG
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 23, 2026
M.U.S.T. PEDICLE SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·September 18, 2025
LANCET-100
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code QRK·April 3, 2026
BD PLASTIPAK LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 23, 2026
BD PLASTIPAK LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 23, 2026
MOTIFESH SOFT TISSUE PATCH (OMYRA IN EUROPE)
FDA Adverse Event
Injury
·PROXY BIOMEDICAL LTD.·Product code FTL·May 27, 2014
OMYRA MESH (BRANDED AS MOTIFMESH IN THE US)
FDA Adverse Event
Other
·PROXY BIOMEDICAL LTD.·Product code FTL·November 20, 2012
ENDURANT II
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·April 16, 2013
2600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 6, 2011
LEVEEN COACCESS NEEDLE ELECTRODE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code JOS·June 13, 2008