13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Electronic Muscle Stimulator (Model MP01)
FDA 510(k)
FDA Class 2
·Physical Medicine
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120700·Steinmann Pin 3.5x230mm (9/64 x 9")
TLC MODELS ULK-H AND ULT-H INFRARED LAMPS
FDA 510(k)
FDA Class 2
·Physical Medicine
NORMED PELLEGRIN CALCANEUS STOP SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·April 22, 2025
GORE® TAG® THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·October 1, 2015
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 6, 2014
CURLIN ADMINISTRATION SET
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code FRN·July 26, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 18, 2013
BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·July 31, 2025
BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·December 23, 2024
BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·March 11, 2025
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025