BEUDAMED
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    CENTRALSCOPE 12

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GRADIA®

    FDA UDI
    Gc America Inc.·D0479010721·GRADIA PLUS Paste HB-DA3.5, 3.3ml, 1pc

    AXIAL RING HANDLE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09929010720·AXIAL RING HANDLE WITH RATCHET

    Symmetry Surgical

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482129142·Symmetry® Forceps; Monopolar Cup Tooth Grasping...

    NexGen®

    FDA UDI
    Zimmer, Inc.·00889024201873·

    Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD¿ IV SET AN120 W/O BP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code LHI·April 5, 2019

    RCSP RETROGRADE CANNULA

    FDA Adverse Event
    Injury ·MEDTRONIC PERFUSION SYSTEMS·Product code DWF·November 13, 2013

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MAF·June 30, 2014

    LIFEPAK 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·November 10, 2010

    URETEX SUPPORT PP TRANSOBTUR KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·October 19, 2012

    IV SET AN120 W/O BP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FRN·April 1, 2019

    Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION EXTRAMEDULLARY PROXIMAL TELESCOPING ROD, REF 00-5901-072-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code MBH·March 14, 2011

    GE Healthcare, Drapes and Sterile Covers PART NUMBER DESCRIPTION 00-900352-01 DRAIN BAG W/HOSE (2000/2500) 2.0 PE MATERIAL 00-900352-01-OEC STRL, BAG, DRAIN WITH PLASTIC CLIPS AND HOSE 2000,2500 00-900352-02 STRL, BAG, DRAIN WITH METAL TABS 00-900493-03 COVER DISPOSABLE X-RAY TUBE 00-900605-01 UROFAST DRAIN BAG (UROFAST ONLY) 00-900605-01-OEC STRL, BAG, DRAIN, WITH HOSE, UROFAST 00-900885-01 URO2600 DRAIN BAG 2.0 PE MATERIAL 00-900885-01-OEC STRL, BAG, DRAIN, URO2600 00-900943-01 STRL, COVER, CARM, HALF BAG, 36X80, 90,94,76 00-900974-01 STRL, DRAPING, MINI-CARM, KYBRD, BLK FTSW, 6600 00-901072-01 URO 2600 DISPOSABLES PACK 2.0 PE MATERIAL 00-901072-01-OEC STRL, PACK, DISPOSABLES, UROVIEW 2600 00-901169-01 12 TUBE DRAPE (36X36) 2.0 PE MATERIAL 00-901169-01-OEC STRL, COVER, DISPOSABLE, 12 INCH TUBE 9600 00-901268-01 DRAPE,STERIQUIK, STANDARD&SUPER- C,9600/7700 00-901390-01 STRL, DRAPING, KEYBOARD, FOOTSWITCH, 20PACK, 6600 00-901391-01 STRL, DRAPE, C-ARM ONLY, 6600 00-901392-01 STRL, COVER, KEYBOARD, 66,68 00-901501-01 9600/9800/SUPER C DISPOSABLES PACK 2.0 PE MATERIAL 00-901501-01-OEC STRL, PACK, DISPOSABLES, MODEL 9800, 20 PACK 00-901581-01-OEC STRL, COVER, DISPOSABLE, IR REMOTE, 9600, 9800 00901588-01 12 C ARM DISPOSABLES PACK 2.0 PE MATERIAL 00-901588-01-OEC STRL, PACK, DISPOSABLES, 12 INCH, 20 PACK SCD 9600 00-901761-01 STRL, DISPOSABLES PACK, UROVIEW 2800 00-901831-02 STRL, COVER, FLUOROTRAK MONITOR, DISPOSABLE BOX 10 PER PKG 00-901832-01 STRL, APIX, COVER, DISPOSABLE CONTROLPANEL COVERS, REPLACEMENT PART CASE OF 25 00-901917-01 STRL, DRAPE, C-ARM, 6800 00-901918-01 MINIVIEW 6800 C-ARM CONSUMABLES PACK GRAY FOOTSWITCH 00-901918-01-OEC STRL, DRAPE, 20 PACK, 6800 00-902752-01 STRL, RUI COVERS 25 COVERS 00-902753-01 STRL, PACK, DISPOSABLE, 9800MD, 9 INCH 20 PACKS 00-902754-01 STRL, PACK, DISPOSABLE, 9800MD, 12 INCH 20 PACKS 00-902776-01 STRL, DRAPE, VASCULAR 00-902864-01 STRL, DRAPE, HALF, C ARM, 9800 9600 00-902934-01 STRL, DRAPE, WORKSTATION, 20 PER BOX, 9900 1003135 STRL, BAG, FLAT PANEL E7009AE STRL, DRAPE, AFM/CFM PEDESTAL, 25 PER BOX E7009AF STRL, DRAPE, AFM/CFM JOYSTICK, 50 PER BOX E7009AG STRL, DRAPE, LARGE DOME BAG, 20 PER BOX E7009AH STRL, DRAPE, MEDIUM DOME BAG, 20 PER BOX E7009AJ STRL, DRAPE, SMALL DOME BAG, 20 PER BOX Sterile EO, Distributed by GE Medical Systems, Milwaukee, WI 53201, Manufactured by Contour Fabricators, Inc. Fenton, MI 48430. The disposable sterile product provide a sterile barrier between the imaging device and sterile surgical field.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MMP·August 29, 2008

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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