BEUDAMED
    17 results · 38ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193105192·HA PEEK EVOS Curved, , 14mmx11mmx 30mm , BICONV...

    Symmetry Lucae

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482035801·Symmetry® Forceps, Lucae Bayonet Dressing, Serr...

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0130140·Sagittal Bender, Right

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668108895·SHAHINIAN LACRIMAL CANNULA STRAIGHT

    AutoPulse®Resuscitation System

    FDA UDI
    Zoll Circulation, Inc.·00849111002455·The AutoPulse System consists of 4 primary comp...

    BLOCK CEMENT RESTRICTOR (CR) - TITANIUM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SOMATOM EMOTION MS

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 27, 2025

    AutoPulse®Resuscitation System

    FDA UDI
    Zoll Circulation, Inc.·00849111002189·The AutoPulse System consists of 4 primary comp...

    GRAFTYS BCP (510K NUMBER: K073064)

    FDA Adverse Event
    Injury ·GRAFTYS·Product code MQV·July 11, 2013

    PROCEDURAL STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·April 6, 2013

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code DQX·September 9, 2014

    ACCU-CHEK TENDER

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FPA·April 21, 2011

    Surgipath Cyto Jar Fixative; a 120 mL clear, leakproof container prefilled with 45 mL of preservative containing polyethylene glycol for the convenient collection, fixation and preservation of all cytologic specimens, 50 jars per case; for in vitro diagnostic use only; Leica Biosystems, 5205 Rt. 12, Richmond, IL 60071; Made in USA The Cyto Jar is for the convenient collection, fixation and preservation of all cytologic specimens. The 120 mL clear, leakproof container is prefilled with 45 mL of preservative containing polyethylene glycol. It can be used for rinsing aspiration needles or bronchial brushes and for the direct collection of sputum specimens.

    FDA Recall
    Terminated ·Leica Biosystems Richmond Inc.·Product code LEA·February 20, 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

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018