BEUDAMED
    18 results · 28ms · 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 ×

    PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP40 & MP50

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Premier

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·D6911040304·DONUT PESSARY #4

    Leksell Stereotactic System

    FDA UDI
    Elekta Solutions AB·07340201502280·LEKSELL STEREOTACTIC SYSTEM CLAMP

    Imarc™

    FDA UDI
    Carbon Medical Technologies, Inc.·00858015005486·Tissue Marker System - Core Delivery

    Leksell Stereotactic System

    FDA UDI
    Elekta Solutions AB·07340201502860·LEKSELL STEREOTACTIC SYSTEM CLAMP - HEADREST SU...

    Leksell Stereotactic System

    FDA UDI
    Elekta Solutions AB·07340201502884·LEKSELL STEREOTACTIC SYSTEM CLAMP - FRAME SUPPORT

    Leksell Stereotactic System

    FDA UDI
    Elekta Solutions AB·07340201502877·LEKSELL STEREOTACTIC SYSTEM CLAMP - SPACER

    Myo/Wire II

    FDA UDI
    A & E MEDICAL CORPORATION·10841291101123·SS Suture, 1 per sleeve

    SURE LOCK,A34,10 PK,ORANGE LEVER,CARDIOLINE

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828183390·SURE LOCK,A34,10 PK,ORANGE LEVER,CARDIOLINE

    MXR-2000 MOBILE X-RAY UNIT

    FDA 510(k)
    FDA Class 2 ·Radiology

    HARDYDISK, TETRACYCLINE 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ZIMMER SKIN GRAFT MESHER

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL·Product code FZW·April 3, 2013

    PENUMBRA COIL 400

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·February 15, 2011

    PINNACLE MTL INS NEUT28IDX50OD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 7, 2008

    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    Depuy brand ACE trochanteric nail; sterile, long, left hip, 400 x 13 x 130; Product 925213400.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code HSB·December 11, 2003

    Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744

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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013