25 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
FDA 510(k)
FDA Class 2
·Radiology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040064877·MLR BANDS LR 2 34.5
RIGID GAS PERMEABLE CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
ALI 3D TOOL MODULE FOR MEDICAL IMAGES
FDA 510(k)
FDA Class 2
·Radiology
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·December 13, 2018
PROSPACE PEEK IMPLANT 5 7X8X22MM
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code MAX·June 21, 2013
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·October 31, 2018
TSPACE PEEK IMPLANT 26X11X7MM
FDA Adverse Event
Malfunction
·AESCULAP IMPLANT SYSTEMS·Product code MAX·October 30, 2015
4.0MM 90-S MAX SERFAS ENERGY SUCTION PROBE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code GEI·April 17, 2013
AUTOMATIC ENDOSCOPE REPROCESSOR
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code FEB·June 19, 2008
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·April 14, 2011
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·October 6, 2023
RESONANCE STENT SET
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FAD·July 25, 2018
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·May 29, 2015
Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Detach, 8mm x 23"; Infusion Set, Contact Detach, 8mm x 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code LZO·April 24, 2026
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·October 11, 2018
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·November 22, 2018
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·September 27, 2023
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·August 13, 2018