29 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Z-CAD smile
FDA 510(k)
FDA Class 2
·Dental
RUSCH
FDA UDI
TELEFLEX INCORPORATED·04026704319534·SLICK SET CUFFED STERILE
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190073·+1mm tibial recut block
RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095
FDA Recall
Open, Classified
·Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland·Product code BTR·July 16, 2021
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889981168698·CORTICAL SHANK, Cannulated, 7.0 X 50
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889987168692·CORTICAL SHANK, Cannulated, 7.0 X 50
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100500·Caddie, 4.75mm Screws
Ø3.5mm x 50mm Precontoured Cervical Rods
FDA UDI
XENCO MEDICAL LLC·B064XM21700501·
RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095
FDA Enforcement
Class II
·Completed·Teleflex Medical Europe Ltd·August 25, 2021
Ø3.5mm X 50mm PRECONTOURED CERVICAL RODS
FDA UDI
XENCO MEDICAL LLC·B064XMPH21700502·
R & D SYSTEMS XERET HEMATOLOGY CONTROL
FDA 510(k)
FDA Class 2
·Hematology
VITALITY HIP SYSTEM MODEL#420
FDA 510(k)
FDA Class 2
·Orthopedic
0 POLYSORB ENDOSTITCH
FDA Adverse Event
Injury
·COVIDIEN·Product code OCW·October 8, 2020
STELLARIS ELITE VISION ENHANCEMENT SYSTEM
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code HQC·March 1, 2022
25 GA POSTERIOR WIDE-FIELD ELITE PACK
FDA Adverse Event
Malfunction
·BAUSCH + LOMB, INC·Product code HQC·December 6, 2019
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 14, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·June 14, 2013
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·July 13, 2011
STELLARIS POWER SUPPLY II
FDA Adverse Event
Malfunction
·BAUSCH + LOMB·Product code HQC·August 1, 2023
EVOLUT R TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·November 30, 2017