16 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SONOSURG TROCAR
FDA 510(k)
FDA Unclassified
·Unknown
Bard® Nasogastric Sump Tube
FDA UDI
C. R. Bard, Inc.·00801741052262·Bard® Nasogastric Sump Tube
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192862·16mm X 100mm Stem Pilot
XIA SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408
FDA 510(k)
FDA Class 2
·Dental
BARD® NASOGASTRIC SUMP TUBE
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code BSS·July 21, 2025
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 9, 2013
INSERTER-LARGE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code LXH·March 28, 2011
SWEET PICOTIP RX
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
UNK - KITS/SETS: FNS IMPLANT KIT
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code MNI·May 4, 2022
ARROW CVC SET: 2-LUMEN 4 FR X 5 CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code DQY·September 10, 2024
ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code FOZ·August 8, 2023
UNK - KITS/SETS: FNS IMPLANT KIT
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code MNI·May 7, 2022
UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KTT·May 4, 2022
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