20 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STAODYN MAX PRESET, MODEL 4470
FDA 510(k)
FDA Class 2
·Neurology
Epimed
FDA UDI
EPIMED INTERNATIONAL, INC·00818788020277·RX Epidural Needle 16g TW x 4.5"
INFANT FLOW SYSTEM, MODEL M672P
FDA 510(k)
FDA Class 2
·Anesthesiology
PASCO MIC AND MIC/ID PANELS
FDA 510(k)
FDA Class 2
·Microbiology
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523173778·Tk C, Cage Trial/Broach, No Stops - 16.1 X 13.5...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523173761·Tk C, Cage Trial/Broach, No Stops - 16.1 X 13.5...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523173747·Tk C, Cage Trial/Broach, No Stops - 16.1 X 13.5...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523173730·Tk C, Cage Trial/Broach, No Stops - 16.1 X 13.5...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523173792·Tk C, Cage Trial/Broach, No Stops - 16.1 X 13.5...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523173754·Tk C, Cage Trial/Broach, No Stops - 16.1 X 13.5...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523173785·Tk C, Cage Trial/Broach, No Stops - 16.1 X 13.5...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 21, 2026
CADD MEDICATION CASSETTE
FDA Adverse Event
Malfunction
·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code FPA·April 28, 2025
TRULIANT KNEE COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 20, 2026
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 16, 2013
IAB: 8 FR - 40 CC
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·March 16, 2011
HIRES 90K
FDA Adverse Event
Malfunction
·ADVANCED BIONICS LLC·Product code MCM·June 17, 2008
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
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018