15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NUMED TYSHAK AND Z-MED PTV CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
BCS SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
ACL TOP
FDA Adverse Event
INSTRUMENTATION LABORATORY CO.·Product code GKP·May 13, 2005
ACL TOP
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code GKP·July 21, 2005
ACL ADVANCE
FDA Adverse Event
INSTRUMENTATION LABORATORY CO.·Product code JPA·April 22, 2005
ENERGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 9, 2013
HS III PROXIMAL SEAL SYSTEM 3.8MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·February 24, 2011
SELUTE PICOTIP
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
AGILIA VP MC
FDA Adverse Event
Malfunction
·FRESENIUS VIAL S.A.S·Product code FRN·June 27, 2025
AGILIA VP MC WIFI
FDA Adverse Event
Malfunction
·FRESENIUS VIAL S.A.S.·Product code FRN·January 27, 2025
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
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
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018