15 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROCEED VENTRAL PATCH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526189782·***DISC***LEVAMED ACTIVE ANKLE SUP BL
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496061533·FREE LEGS, SIZE ML, NERO, MICRO-MASSAGING ANTI-...
SURGIFLATOR-40
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEPUY FEMORAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
AN UNSPECIFIED CLOSED SYSTEM ART LINE TRANSUDUCER
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·March 18, 2025
UNSPECIFIED SAFESET TRANSPAC SETS
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·January 2, 2025
UNSPECIFIED CENTRAL LINE TRANSDUCER SET
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·November 5, 2024
AN UNSPECIFIED CLOSED SYSTEM ART LINE SYRINGE
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·March 18, 2025
VERSACRE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 27, 2013
IAB : 7.5 FR - 30 CC
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·March 16, 2011
EVAQUA INFANT BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BZE·June 17, 2008
BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US)
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Company·July 27, 2022
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018