13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V
FDA 510(k)
FDA Class 2
·General Hospital
LEONE SPA
FDA UDI
LEONE SPA·08033707065753·INTRAORAL ELASTICS 6,5 oz 5/16" blue
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450473962·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450473986·
NEOCIF INSERTION INSTRUMENT
FDA Adverse Event
Malfunction
·BIOMET SPAIN, S.L.·Product code MQP·November 6, 2018
DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK
FDA 510(k)
FDA Class 2
·General Hospital
NEOCIF INSERTION INSTRUMENT
FDA Adverse Event
Malfunction
·BIOMET SPAIN, S.L.·Product code MQP·July 20, 2017
SETROX S 45
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVZ·May 4, 2011
PASSPORT 2 MONITOR
FDA Adverse Event
Malfunction
·MINDRAY USA, INC.·Product code MHX·April 30, 2013
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 5, 2014
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