11 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FRESENIUS STERILE STAY SAFE CAP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PREAMP CABLE, MODEL B400-1011PA
FDA 510(k)
FDA Class 2
·Cardiovascular
DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 9, 2025
AVIATOR ASSY TWO LEVEL PLATE SIZE 28
FDA Adverse Event
Injury
·STRYKER SPINE-FRANCE·Product code KWQ·October 17, 2016
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 28, 2022
MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F
FDA Adverse Event
Injury
·ACCESSCLOSURE, INC.·Product code MGB·April 29, 2013
SEE H-10
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code HQL·May 10, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·July 28, 2008
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
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018