18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EVIS EXERA 180 SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MI Product Line
FDA UDI
Medical Illumination International Inc.·00816835020089·MI-500 Examination Light, Floor Stand
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70613131·Sprint II Brackets McLaugh/Benn/Trev. .022" 100...
Epimed
FDA UDI
EPIMED INTERNATIONAL, INC·00818788020222·RX Epidural Needle 13g TW x 4.0"
Vista LED
FDA UDI
Avante·00815871021814·DRE Vista LED, FLOOR
MI Product Line
FDA UDI
Medical Illumination International Inc.·00816835020645·MI-500 Examination Light, Floor Stand
Vista LED
FDA UDI
Avante·00815871021852·DRE Vista LED, FLOOR
SEARCH EVOLUTION TOTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AIRDENT II CS
FDA 510(k)
FDA Class 2
·Dental
AGILIS¿NXT STEERABLE INTRODUCER DUAL-REACH¿
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.·Product code DYB·March 29, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 13, 2025
SECURE ACUTE CARE BED 3/01
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 16, 2013
LADARVISION 4000
FDA Adverse Event
Injury
·ALCON - ORLANDO TECHNOLOGY CENTER·Product code LZS·June 13, 2008
VANDERLIFT 450
FDA Adverse Event
Other
·VANCARE, INC.·Product code FSA·April 5, 2011
Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like devices intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement; available in nonsterile configuration.
FDA Enforcement
Class II
·Terminated·Precision Dynamics Corporation·August 14, 2013
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 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