14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SILVERLON CONTACT WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
MICROSPEED EC MOTORSYSTEM GD650/GD653
FDA 510(k)
FDA Class 2
·Neurology
INCARE PELVIC FLOOR THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ApeCord
FDA UDI
RIVERPOINT MEDICAL, LLC·00840277409812·White/Black UHMWPE Polyblend Non-Absorbable Suture
ApeCord
FDA UDI
RIVERPOINT MEDICAL, LLC·00840277409805·Black UHMWPE Polyblend Non-Absorbable Suture
ApeCord
FDA UDI
RIVERPOINT MEDICAL, LLC·00840277409799·White/Black UHMWPE Polyblend Non-Absorbable Suture
ApeCord
FDA UDI
RIVERPOINT MEDICAL, LLC·00840277409782·Black UHMWPE Polyblend Non-Absorbable Suture
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 28, 2025
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·March 27, 2013
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Other
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·January 7, 2011
ACRYSOF TORIC
FDA Adverse Event
Other
·ALCON RESEARCH, LTD./ HUNTINGTON·Product code HQL·March 28, 2008
EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE
FDA Adverse Event
Malfunction
·SHIRAKAWA OLYMPUS CO., LTD.·Product code PSV·March 14, 2024
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