BEUDAMED
    99 results · 20ms · 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 FDA Recall ×

    EZ-DOP, diagnostic ultrasound imaging system

    FDA Recall
    Terminated ·DWL Systems, Inc.·Product code IYN·January 5, 2004

    Tennis Elbow Support, Neoprene***LATEX FREE" Product Usage: Provides compression and warmth for mild to moderate elbow strains and sprains.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code DWL·March 19, 2014

    DROP LOK" Knee Brace***LATEX FREE" Product Usage: Used in the treatment, support, and rehabilitation of many types of knee injuries or following surgical correction.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code DWL·March 19, 2014

    Cartilage Knee Brace***LATEX FREE" Product Usage: Used in the treatment and support of many types of knee injuries or following surgical and nonsurgical correction.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code DWL·March 19, 2014

    Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral stability and allows the knee to tolerate more strenuous activity during recuperation.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code DWL·March 19, 2014

    Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010-XWTL, 370000-XWL, 360010-1WTL, 360010-XWT, 360010-2, 370000-2W, 360010-2L, 370000-2WL, 360010-X, 370000-XW, 360010-2W, 362010-2, 360010, 37000-XWL, 362010-X, 362010-XL, 362010-1L, 360010-XL, 37000-1W, 360010-XW, 3700000-1W, 362010-2L, 36010-XWT, 370000-1L, 360010-2WT, 360000-1, 360010-XWSB, 360010-XLSB

    FDA Recall
    Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

    Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

    FDA Recall
    Terminated ·Ebi, Llc·Product code OVE·November 11, 2014

    PathFinder Cannulated T-Handle Bone Awl, Part Number 1155-2; distributed by Abbott Spine, Inc., Austin, TX 78727.

    FDA Recall
    Terminated ·Abbott Spine·Product code NKB·April 17, 2008

    Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No

    FDA Recall
    Open, Classified ·SEASPINE ORTHOPEDICS CORPORATION·Product code HWJ·June 4, 2024

    LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and Battalion LLIF,

    FDA Recall
    Open, Classified ·Alphatec Spine, Inc. 1950 Camino Vida Roble·Product code HWJ·July 7, 2023

    Optimus Fixed Awl

    FDA Recall
    Terminated ·Amendia, Inc·Product code OVD·November 22, 2016

    Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable Sleeves are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae. The Timberline Retractable Drill and the Timberline Retractable Awl fit within this Sleeve. Spinal Surgical Device.

    FDA Recall
    Terminated ·Biomet Spine, LLC·Product code OVD·August 22, 2013

    CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K

    FDA Recall
    Open, Classified ·Medtronic Sofamor Danek USA, Inc·Product code OLO·July 12, 2023

    PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.

    FDA Recall
    Terminated ·Abbott Spine·Product code NKB·July 18, 2007

    PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.

    FDA Recall
    Terminated ·Abbott Spine·Product code NKB·July 18, 2007

    TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.

    FDA Recall
    Open, Classified ·Product code OVD·July 15, 2024

    Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.

    FDA Recall
    Terminated ·Biomet Spine, LLC·Product code OVD·August 22, 2013

    PALLAS M/MAXIMIS Awl. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

    FDA Recall
    Terminated ·Valorem Surgical LLC·Product code MNI·June 21, 2017

    Flexible Bone Awl; SJ607R; NON STERILE; B Braun Aesculap; Aesculap AG: These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.

    FDA Recall
    Terminated ·Aesculap, Inc.·Product code LRZ·November 10, 2015

    8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code HTO·July 1, 2015