14 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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PEDIATRIC AORTIC ROOT CANNULA
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257126691·15-20 MV FOR MEN SELECT EW STD TAN III
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257128756·15-20 MV FOR MEN CLSC EW STD TAN III
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120401731·Abrasive, green, medium grit
VERTE-STACK ANATOMIC PEEK STRUT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·May 5, 2020
CEMENT IT! UNIVERSAL C&B
FDA 510(k)
FDA Class 2
·Dental
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE (0.12-128 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
PROGRASP FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·November 19, 2013
BRILLIANCE 64 AIR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code JAK·April 3, 2013
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·April 5, 2011
STARCLOSE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·May 8, 2008
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·December 18, 2019
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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018