BEUDAMED
    14 results · 12ms · 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 Status: Terminated ×

    Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity. The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are intended for single use only and are to be implanted without bone cement.

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew, Inc.·January 11, 2017

    Airway Mobilescope MAF-TM

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOQ·August 8, 2018

    Airway Mobilescope MAF-TM

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 10, 2018

    LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 8630-0107. The Timberline MPF device is an intervertebral body fusion device consisting of a PEEK intervertebral spacer, titanium plate, and screws. The PEEK spacer has a generally rounded shape with various heights and footprints and has a hollowed out central area to accommodate autogenous bone graft. The upper and lower surfaces have a series of transverse grooves formed to improve stability and fixation once the device is inserted. The titanium plate has holes for receiving bone screws and a central hole for receiving a cover plate to prevent screw back-out. The Timberline MPF system is available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The Timberline MPF system is provided nonsterile. The Driver is used with the Timberline MPF system to drive titanium screws through the plate and into the vertebrae thus locking plate to the vertebrae.

    FDA Enforcement
    Class II ·Terminated·Lanx, Inc.·December 4, 2013

    Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored Lateral Retractable Drills are used with the Timberline MPF System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.

    FDA Enforcement
    Class II ·Terminated·Biomet Spine, LLC·January 21, 2015

    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 Enforcement
    Class II ·Terminated·Biomet Spine, LLC·January 21, 2015

    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 Enforcement
    Class II ·Terminated·Biomet Spine, LLC·January 21, 2015

    3D Ceiling Suspension

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IZF·April 15, 2003

    Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code IZF·July 16, 2018

    Cesar-DMCP-Visub(HM2000/3000), System Code 72239 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code IZF·July 16, 2018

    Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code IZF·July 16, 2018

    AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications

    FDA Recall
    Terminated ·Agfa N.V. Septestraat 27 Mortsel Belgium·Product code IZF·February 10, 2020

    Baxter Three-Way Large Bore Stopcock with Rotating Male Luer Lock Adapter; a sterile, nonpyrogenic fluid pathway; Baxter Healthcare Corporation, Deerfield, IL 60015; product code 2C6201. Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device. The stopcock was sold alone and as a component of the following I.V. Administration Sets: a) product code 1C8471, Baxter Interlink System Large Bore 3-Way Stopcock with Rotating Male Luer Lock Extension Set, 44", Vol. 5.9 mL; b) product code 2N5600, Baxter Interlink System Large Bore 3-Way Stopcock with Rotating Male Luer Lock, Vol. 0.7 mL; c) product code 3C0114, Baxter Interlink System Continu-Flo Solution Set, 66", 2-Port Manifold with Check Valves, and Large Bore 3-Way Stopcock with Rotating Male Luer Lock Extension Set, 40", Vol. 5.6 mL; d) product code 3C0180, Baxter Clearlink System Non-DEHP Continu-Flo Solution Set, 108", Large Bore 3-Way Stopcock with Rotating Male Luer Lock Extension Set, 30", Vol. 3.9 mL, and Extension Set, 7", 0.9 mL; e) product code 3C0021, Baxter Interlink System Continu-Flo Solution Set, 65" with Large Bore 3-Way Stopcock with Rotating Male Luer Lock Extension Set, 61", Vol. 9.1 mL; f) product code 3C0174, Baxter Interlink System Buretrol Solution Set, 58", Large Bore 3-Way Stopcock with Rotating Male Luer Lock Extension Set, 43", Vol. 6.1 mL, and Minivolume Extension Set, 6", 0.6 mL; g) product code 3C0098, Baxter Interlink System Solution Set, 30", Extension Set, 44", Large Bore 3-Way Stopcock with Rotating Male Luer Lock Extension Set, 29", Vol. 3.9 mL, 3-Port Manifold with Check Valves and Extension Set, 7"; h) product code 3C0090, Baxter Interlink System Continu-Flo Solution Set, 107" with Large Bore 3-Way Stopcock with Rotating Male Luer Lock Extension Set, 38", Vol. 5.8 mL; i) product code 3C0175, Baxter Interlink System Buretrol Solution Set, 56", Two Large Bore 3-Way Stopcocks with Rotating Male Luer Lock Minivolume Extension Set, 53", 1.5 mL;

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FMG·October 28, 2010

    Leica M520 Surgical Microscope; a surgical microscope with a 6:1 motorized zoom magnification, 207-470 mm motorized Multi-Foc variable objective lens with diameter and light intensity of illuminated field continuously adjustable and high power 300W xenon lamp (both main and back-up illimuniation) through fiber optic cable; Leica Microsystems (Schweiz) AG, Business Unit SOM, Max Schmidheiny-Strasse 201, CH-9435 Heerbrugg, Switzerland; Leica Microsystems Inc., 90 Boroline Road, Allendale, NJ 07401; Leica Microsystems Inc., 2345 Waukegan Road, Bannockburn, IL 60015-9792 The M520 microscope was sold with the following floor stands to form Leica Surgical Microscope Systems: a) MS-1 floor stand with manual balancing for the microscope carrier in three axes and three electromagnetic and mechanical brakes; b) MS-2 floor stand with 3 step balancing for the optical head, autobalance for the floor stand and six electromagnetic brakes; c) MS-3 floor stand with semi-automatic balancing system and six electromagnetic permanent magnetic brakes, cantilever range: 1456 mm d) ) OHS1 floor stand with semi-automatic balancing system and six electromagnetic permanent magnetic brakes, e) OH3 floor stand with fully-automatic balancing system and six electromagnetic permanent magnetic brakes, cantilever range: Max. 1520 mm f) F40 floor stand with continuously adjustable balancing system and four electromagnetic permanent magnetic brakes, Maximum reach 1496 mm

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code EPT·April 12, 2005