10 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY)
FDA 510(k)
FDA Class 2
·Ophthalmic
KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN
FDA 510(k)
FDA Class 2
·Cardiovascular
ADVENT IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
M2A-MAGNUM MODULAR HEAD SZ 44MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 17, 2013
TRIATHLON CR X3 TIBIAL INSERT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·April 8, 2011
ABS2000
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·June 23, 2008
ANGIODYNAMICS / SMART PORT
FDA Adverse Event
Malfunction
·ANGIODYNAMICS·Product code LJT·August 21, 2017
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015
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