BEUDAMED
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    REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS

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

    Echo-Screen III

    FDA UDI
    Natus Medical Denmark ApS·05713315012051·Echo-Screen III 4' OAE Cable, Tested, V.2

    Echo-Screen III

    FDA UDI
    NATUS MEDICAL INCORPORATED·00382830044714·Echo-Screen III 4' OAE Cable

    Omnilink Elite

    FDA UDI
    ABBOTT VASCULAR INC.·08717648179341·Omnilink Elite Vascular Balloon-Expandable Sten...

    Omnilink Elite

    FDA UDI
    ABBOTT VASCULAR INC.·08717648179334·Omnilink Elite Vascular Balloon-Expandable Sten...

    Omnilink Elite

    FDA UDI
    ABBOTT VASCULAR INC.·08717648179358·Omnilink Elite Vascular Balloon-Expandable Sten...

    Omnilink Elite

    FDA UDI
    ABBOTT VASCULAR INC.·08717648179327·Omnilink Elite Vascular Balloon-Expandable Sten...

    Claymount

    FDA UDI
    Varex Imaging Nederland B.V.·08718755000474·x-ray beam-limiting device, to restrict the dim...

    EUROSPITAL EU-TTG IGA UMANA

    FDA 510(k)
    FDA Class 2 ·Immunology

    METHAFILCON A

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    0009613348-2024-012625

    FDA Adverse Event
    Injury ·INSTITUT STRAUMANN AG·Product code DZE·September 23, 2024

    ARCHITECT CA 19-9XR

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code NIG·July 20, 2012

    PLATE,FIXATION,BONE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HRS·May 9, 2014

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·February 21, 2013

    ASR ACETABULAR CUPS 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011

    IDC - INTERLOCKING DETACHABLE COIL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORK, LTD.·Product code HCG·March 10, 2008

    SHELL POROUS WITH CLUSTER HOLES 54 MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·May 3, 2022

    Facial Pack , part number AMS6501

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    Ulnar Shorting Saw Blade is labeled in part: "Congruent Bone Plates, SIZE Ulnar Shortening Saw Blade - Hub Style S, REF 80-0499-S, Material: Stainless Steel, STERILE, Rx Only, ACUMED, Hillsboro, OR, USA". The Ulnar Saw Blade is an accessory used with a Congruent Bone Plate System covered under K012655, but it is labeled and sold separately by itself. The saw blade is also sold as part of the Upper Extremity Osteotomy System (BOM 15-0030). The BOM 15-0030 system does not have a label, but the saw blade is individually labeled and shipped together with this system when it is ordered. Intended use: Cutting Bones

    FDA Recall
    Terminated ·Acumed LLC·Product code HRS·April 14, 2010

    Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·October 18, 2017