15 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NON-STERILE POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH ALOE VERA AND VITAMIN E
FDA 510(k)
FDA Class 1
·General Hospital
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132080·Trial, TLIF, 27L OB CRV 7Deg, 8mm
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033477922·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033477915·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033477908·
ANEUVYSION MULITICOLOR DNA PROBE KIT
FDA 510(k)
FDA Class 2
·Immunology
ORIGEN DUAL LUMEN CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MOTO PARTIAL KNEE SYSTEM - MEDIAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·December 24, 2025
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 20, 2013
CRYOVALVE PULMONARY VALVE & CONDUIT
FDA Adverse Event
Injury
·CRYOLIFE, INC.·Product code MIE·March 10, 2011
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·March 14, 2008
MOTO PARTIAL KNEE SYSTEM - MEDIAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·February 16, 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
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022
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