BEUDAMED
    22 results · 18ms · Sources: EU EUDAMED, US FDA

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    DATA MANAGEMENT SYSTEM IL MODEL 775

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209102754·KIT, NAR-4 CHEST POUCH w' CELOX GAUZE - ODG

    TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00;

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

    ENDO GIA ROTICULATOR 60-3.5 SULU

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL·Product code GDW·May 2, 2014

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·October 8, 2012

    PRECISION XTRA/OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·September 28, 2007

    SURSHIELD PUR SAFETY I.V. CATHETER

    FDA Adverse Event
    Injury ·TERUMO CORPORATION - KOFU·Product code FOZ·December 22, 2017

    Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.

    FDA Recall
    Terminated ·Aesculap Implant Systems LLC·Product code PUI·October 1, 2019

    AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle

    FDA Recall
    Terminated ·Aesculap Implant Systems LLC·Product code HXK·September 25, 2019

    CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.

    FDA Recall
    Terminated ·Aesculap Implant Systems LLC·Product code GEI·August 7, 2019

    CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.

    FDA Recall
    Terminated ·Aesculap Implant Systems LLC·Product code GEI·August 7, 2019

    JS Series SterilContainer S2 System

    FDA Recall
    Terminated ·Aesculap Implant Systems LLC·Product code KCT·September 8, 2017

    Bariatric Target Ring (Nitinol) (a thin, circular nitinol ring) Model # K-9536-N, Lot #08-001, Lot #08-002 & Lot #08-003. One ring per plastic pouch, three rings are then placed into a plastic box with lid. This box is then placed into a solid white box. Item is shipped and sold non-sterile. It is intended to be used to radiographically (with X-Ray) mark the site of the "gastropexy" performed during gastric bypass surgery, thereby making it accessible for future diagnostic, therapeutic and feeding purposes.

    FDA Recall
    Terminated ·Kapp Surgical Instrument Inc·Product code NEU·May 24, 2011

    STRIP T's STERILE ADHESIVE ORGANIZER, Model #SC5000-4R, Lot #090710, 510(k) exempt. One (1) adhesive organizer is packed in a Tyvek pouch and 60 pouches are placed into a 'Shelf Box'. The shelf box is placed into a shipping container. The Sterile Adhesive Organizer is used to hold tubing or instruments to the drape in surgery.

    FDA Recall
    Terminated ·Kapp Surgical Instrument Inc·Product code KGT·March 5, 2008

    Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide Central Nervous System Shunt and Components intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

    FDA Recall
    Terminated ·Aesculap, Inc.·Product code JXG·June 4, 2012

    The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

    FDA Recall
    Terminated ·Aesculap Implant Systems LLC·Product code HBB·September 1, 2017

    PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13

    FDA Recall
    Terminated ·Aesculap Implant Systems LLC·Product code FZP·April 16, 2021

    PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU

    FDA Recall
    Terminated ·Aesculap Implant Systems LLC·Product code FZP·April 16, 2021

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021