BEUDAMED
    98 results · 11ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, Lp·August 7, 2019

    Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.

    FDA Enforcement
    Class II ·Terminated·Jjgc Industria E Comercio De Materials Dentarios Sa·February 12, 2020

    Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provide a concentric pathway for the drills and taps to access the bone while protecting the soft tissue from the cutting geometry of the drills/taps. In addition the drill guide is used as a reference to measure depth that the drills and taps are protruding into bone, which is measured by depth markings at the proximal end of the drills/taps relative to the proximal end of the drill guide. These devices were used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients.

    FDA Enforcement
    Class II ·Terminated·SpineFrontier, Inc.·August 14, 2013

    SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopaedic surgery (large and small bone surgeries) to cut bone

    FDA Enforcement
    Class II ·Terminated·MicroAire Surgical Instruments, LLC·February 7, 2018

    Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 10, 2018

    Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080

    FDA Enforcement
    Class II ·Ongoing·New Standard Device Inc·September 7, 2022

    EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·December 2, 2020

    EMPOWR Partial Knee Peg Drill; Model: 800-06-008.

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·December 2, 2020

    Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consists of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·December 27, 2017

    BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill into bone in hip or knee surgeries.

    FDA Enforcement
    Class II ·Terminated·Brasseler USA I Lp·December 11, 2019

    Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·February 26, 2014

    AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the following lots from vendor 00-0001062., AD0021502, AD0021628. Product Usage: The drill sleeve guides are accessories to the Ad-Tech Cranial Drill Bits. The Cranial Drill Bits and accessories are intended to be used for drilling holes in the skull for neurological procedures, such as brain biopsy, brain contacting electrode and electrode accessory device placement. The DSG-6.3-090-2.4N drill sleeve guides are intended to be used with the 2.4mm Cranial Drill Bit diameter.

    FDA Enforcement
    Class II ·Terminated·Ad-Tech Medical Instrument Corporation·August 1, 2018

    The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is intended to be used with a Medtronic Computer Assisted Surgery System to help assist with screw placement during spine surgical procedures. The device is reusable and requires sterilization according to product labeling. .

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·December 5, 2012

    EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·April 19, 2023

    AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N

    FDA Enforcement
    Class II ·Terminated·Ad-Tech Medical Instrument Corporation·September 25, 2019

    Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·April 13, 2016

    SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation and management of fracture and reconstructive surgery.

    FDA Enforcement
    Class II ·Ongoing·Synthes (USA) Products LLC·October 26, 2022

    Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage device. Part Number: 82-6607

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·May 31, 2023

    Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·April 13, 2016

    Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.

    FDA Enforcement
    Class II ·Terminated·NEOSTEO·August 18, 2021