18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INCARE INTERMITTENT CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033475904·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033476345·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033475874·
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361012436·PedFuse Remind LES, Quad, 6.0mm x 45mm
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033475898·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033475867·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033475850·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033475881·
KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS
FDA 510(k)
FDA Class 2
·Orthopedic
AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
CM ALVIM ACQUA IMPLANT 5.0X11.5 MM
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·September 3, 2018
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·March 20, 2013
ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code KOG·March 10, 2011
NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
FDA Adverse Event
Injury
·CYTYC SURGICAL PRODUCTS·Product code MNB·March 13, 2008
REZUM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 26, 2025
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 Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018