18 results
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31ms
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Sources: EU EUDAMED, US FDA
GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE
FDA 510(k)
FDA Class 2
·Dental
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033491164·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033491188·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033491157·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033491171·
Flexcera™ Smile Ultra+ for Carbon® Printers A1
FDA UDI
Envisiontec GmbH·04260683220843·Flexcera™ Smile Ultra+ for Carbon® Printers is ...
RELION INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·November 25, 2020
RANDOX GLUCOSE (GOD/PAP)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
QUICK-CORE ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FCG·September 4, 2018
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 20, 2013
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·March 10, 2011
NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
FDA Adverse Event
Injury
·CYTYC SURGICAL PRODUCTS·Product code MNB·March 13, 2008
SMR CEMENTLESS FINNED STEM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code HSD·July 29, 2021
SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·November 24, 2020
SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·November 24, 2020
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
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