14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DURAGEN II DURAL REGENERATION MATRIX
FDA 510(k)
FDA Class 2
·Neurology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776382919·McIntyre Cystotome 27ga with sharp cutting poin...
BD SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 12, 2020
MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR, MODELS PHILIPS M3000A/M3046A
FDA 510(k)
FDA Class 2
·Cardiovascular
ZINC PHOSPHATE CEMENT
FDA 510(k)
FDA Class 2
·Dental
SURE-T PARADIGM
FDA Adverse Event
Malfunction
·MEDTRONIC·Product code LZG·May 6, 2014
MERIDIAN FILTER SYSTEM - JUGULAR
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·March 11, 2013
9800MD
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 28, 2011
INSIGNIA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·May 8, 2008
SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
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