14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ANTI-I.V. ENTERAL FEEDING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYNTHES 3.9 MM PELVIC SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
COPELAND RESURFACING HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
BD INTIMA-II¿ CATHETER
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·September 11, 2018
GRAFTON PLUS¿ DBM
FDA Adverse Event
Malfunction
·Product code NUN·August 28, 2020
GRAFTON PLUS¿ DBM
FDA Adverse Event
Malfunction
·Product code NUN·August 28, 2020
HOLMES
FDA Adverse Event
Malfunction
·JARDEN CONSUMER SOLUTIONS, DBA, SUNBEAM PRODUCTS·Product code KFZ·March 15, 2013
ANTERIOR CHAMBER LENS
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·March 25, 2011
SWEET PICOTIP RX
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
BD DISCARDIT¿ II SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·November 12, 2018
Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas vertebra.
FDA Enforcement
Class II
·Terminated·Advanced Orthogonal Equipment, Incorporated·July 31, 2013
AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd, Boardman, OH 44512. Usage: Hospital Bed.
FDA Enforcement
Class II
·Terminated·Primus Medical LLC·November 14, 2012
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