18 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENDO SMARTCAP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENDO SMARTCAP
FDA Adverse Event
MEDIVATORS·Product code KOG·February 2, 2015
FADASSI MEDICAL FM-1 NO BLENDER
FDA 510(k)
FDA Class 2
·Anesthesiology
PYRAMID ANTERIOR PLATE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BD INTIMA-II 22GAX1.00IN PRN SLM NPVC HP
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·January 12, 2026
BD INTIMA-II 22GAX1.00IN PRN SLM NPVC HP
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·January 2, 2026
COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NITI MEDICAL TECHNOLOGIES LTD.·Product code FZP·September 2, 2011
COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·August 26, 2011
UNKNOWN ZIMMER KNEE IMPLANT
FDA Adverse Event
Injury
·ZIMMER INC·Product code JWH·May 1, 2013
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 4, 2014
UNKNOWN DEPUY GLENOSPHERE
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWS·May 12, 2011
INTIMA-II 22GAX1.00IN PRN SLM NPVC HP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·November 13, 2025
BD INTIMA-II 22GAX1.00IN PRN SLM NPVC HP
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·December 16, 2025
INTIMA-II 22GAX1.00IN PRN SLM NPVC HP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·November 11, 2025
BD INTIMA-II 22GAX1.00IN PRN SLM NPVC HP
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·December 17, 2025
BD INTIMA-II 22GAX1.00IN PRN SLM NPVC HP
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·January 9, 2026
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 Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018