BEUDAMED
    65 results · 13ms · Sources: EU EUDAMED, US FDA

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    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080234. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HSB·July 24, 2014

    Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code HRX·May 19, 2014

    SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code NBC·June 23, 2014

    SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code NBC·June 23, 2014

    PKG, ROTATING HANDLE, RATCHET, INSULATED/SHAFT, P/N 0250080233. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code HQC·October 6, 2014

    Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT. Sterile absorbent foam tipped applicator used to apply medication or to obtain specimens from a patient.

    FDA Recall
    Terminated ·Puritan Medical Products Co., LLC·Product code KXG·December 22, 2014

    Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.

    FDA Recall
    Terminated ·JAS Diagnostics Inc.·Product code CFR·October 23, 2014

    Cordis EMPIRA RX PTCA Dilatation Catheter

    FDA Recall
    Terminated ·Cordis Corporation·Product code LOX·June 23, 2014

    Cordis EMPIRA NC RX PTCA Dilatation Catheter

    FDA Recall
    Terminated ·Cordis Corporation·Product code LOX·June 23, 2014

    Vl DBL OFFST WI LRG STPL, RT Nonsterile

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code LXH·July 23, 2014

    VER2 HANDLE, PIN REWORK, LT Nonsterile

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code LXH·July 23, 2014

    VI DBL OFFST W/ LRG STPL, LT Nonsterile

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code LXH·July 23, 2014

    Double Offset Rasp Handle, Left Hand Nonsterile

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code LXH·July 23, 2014

    VER2 D8L OFFSET RASP HANDLE, RT Nonsterile

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code LXH·July 23, 2014

    23.5 Deg Rasp Handle Assy- RIGHT Nonsterile

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code LXH·July 23, 2014

    Double Offset Rasp Handle, Left Hand Nonsterile

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code LXH·July 23, 2014

    Double Offset Rasp Handle, Right Hand Nonsterile

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code LXH·July 23, 2014