BEUDAMED
    41 results · 14ms · 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 ×

    Integra Peritoneal Introducer Sheaths, 61 cm;Integra NeuroSciences/REF 901-124; Manufacturer Integra NeuroSciences Implants S.A., 2905 Route Des Dolines, 06921 SOPHIA ANTIPOLIS Cedex, France; Distributed by Integra NeuroSciences, 311 Enterprise Drive, Plainsboro, NJ 08536, USA Designed to be used with a Peritoneal Introducer of appropriate length during the placement of a peritoneal drainage catheter in the treatment of hydrocephalus. Designed to be used with a Peritoneal Introducer of appropriate length during the placement of a peritoneal drainage catheter in the treatment of hydrocephalus.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code GYK·December 22, 2010

    GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code LXH·April 13, 2022

    GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery

    FDA Recall
    Terminated ·Medacta Usa·Product code KRO·April 17, 2015

    GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1

    FDA Enforcement
    Class II ·Terminated·Medacta Usa Inc·June 15, 2022

    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 Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code NDP·November 15, 2017

    GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement.

    FDA Recall
    Terminated ·Medacta Usa·Product code HSB·September 22, 2014

    Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (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 consist 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 Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code LXH·June 26, 2017

    Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code KRO·May 19, 2017

    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

    GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery

    FDA Enforcement
    Class II ·Terminated·Medacta Usa·November 25, 2015

    Olympus DISPOSABLE GRASPING FORCEPS, FG-51D

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·June 1, 2022

    Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO

    FDA Enforcement
    Class II ·Terminated·Medacta Usa Inc·July 12, 2017

    The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code JWH·October 24, 2017

    The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF

    FDA Enforcement
    Class II ·Terminated·Medacta Usa Inc·December 27, 2017

    GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement.

    FDA Enforcement
    Class II ·Terminated·Medacta Usa·November 19, 2014

    Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (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 consist 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·September 20, 2017

    Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)

    FDA Recall
    Terminated ·GSK Consumer Healthcare·Product code N/A·April 25, 2016

    GYNDisposables Inc, IUD INSERTION KIT 935K, STERILE, SINGLE USE, Tenaculum 356T, Uterine Sound 906S, Scissors, Povidone-Iodine Solution, (3) Swabsticks, Paper Towel, STERILE EO, REF 935K, QTY 1, GYN Disposables,Inc. 2671 Appling Road, Memphis, TN 38133, ph 901.377.2200, fx 901.377.2207 Intended for intrauterine device (IUD) insertion.

    FDA Recall
    Terminated ·GYN Disposables Inc·Product code HDC·July 29, 2011

    Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler (Tao Brush), 9.0Fr/26 cm, 3.5 cm, sterile, Cook Ob/Gyn, Spencer, IN; REF J-ES-090500-BL. Used to obtain endometrial samples for both cytology and histology. Intended for one-time use.

    FDA Recall
    Terminated ·Cook OB/Gyn, Inc.·Product code HFE·April 2, 2009

    Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)

    FDA Enforcement
    Class III ·Terminated·GSK Consumer Healthcare·July 20, 2016