BEUDAMED
    274 results · 10ms · 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 × Status: Terminated × Clear all

    Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any the Flower Small and Medium Implant Set Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set or Flower Upper Extremity Plating Set and uses the medium locking mechanism. Catalog Number: DBK 027

    FDA Recall
    Terminated ·Flower Orthopedics Corporation·Product code HTW·September 1, 2021

    Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any plate as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. Catalog Number: DBK 024

    FDA Recall
    Terminated ·Flower Orthopedics Corporation·Product code HTW·September 1, 2021

    Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. mechanism. Catalog Number: DBK 020 2013002721

    FDA Recall
    Terminated ·Flower Orthopedics Corporation·Product code HTW·September 1, 2021

    Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and Medium Implant Set, Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set , or Flower Upper Extremity Plating Set and uses the medium locking mechanism. Catalog Number: LSK 027

    FDA Recall
    Terminated ·Flower Orthopedics Corporation·Product code HTW·September 1, 2021

    Ti-Magna Fx Washer Ti-Versa-FXII Femoral Fixation System S/C Plates The compression tube/plates of this trauma system are used with Ti-Versa-Fx II Femoral Fixation System lag screws for the internal fixation of proximal femoral and supracondylar fractures. The Ti-Magna Fx System is an osteosynthesis item for orthopedic use in open internal fixation of fractures of the femoral neck, condyle, or tibia, etc. The washer prevents the screw head from being buried in the bone.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code NDG·August 28, 2013

    ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures.

    FDA Recall
    Terminated ·Zavation·Product code NDN·March 25, 2021

    Syneture Sofsilk 3/0 BK 12X18" PRE-CUT WAX-RACE non-absorbable braided nylon sutures S194 Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery

    FDA Recall
    Terminated ·Product code GAP·June 3, 2011

    Single-use sterile puncture attachment UA1256-U used with the BK Medical Ultrasounds: Diagnostic Ultrasound scanner Pro Focus 2202 and Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound scanner 2102 and Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound scanner 2101 and Diagnostic Ultrasound Transducer 8667 Performing ultrasound guided biopsies of the prostate.

    FDA Recall
    Terminated ·Bk Medical Mileparken 34 Iierlev Denmark·September 8, 2008

    BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN

    FDA Recall
    Terminated ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·June 28, 2016

    AMPLATZER Exchange System 45-degree curve, order no. 9-EXCH-12F-45/80. Product is labeled as Sterile EO. The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER Delivery System, which is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The only exception is the dilator component in the Exchange System has a larger inner lumen to allow passage over an AMPLATZER delivery cable. Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.

    FDA Recall
    Terminated ·AGA Medical Corporation·Product code GBK·November 23, 2004

    VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc.

    FDA Recall
    Terminated ·Viasys Respiratory Care, Inc.dba Bird Products·Product code CBK·January 31, 2007

    Maquet Servo Ventilator SV900C/D/E (SV900) Siemens-Elema AB, Solna, Sweden

    FDA Recall
    Terminated ·MAQUET Inc.·Product code CBK·November 17, 2009

    Ventilator System SERVO-i V3.1 PC1777 Maquet Critical Care

    FDA Recall
    Terminated ·MAQUET Inc.·Product code CBK·May 23, 2006

    Ventilator System Servo-i V3.1 Maquet Critical Care PC1771

    FDA Recall
    Terminated ·MAQUET Inc.·Product code CBK·May 23, 2006

    RP Diaphragm Exhalation model number FC06372. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code CBK·October 15, 2007

    Rotating Connector Packaged model number 302209. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code CBK·October 15, 2007

    Newport e360 Ventilator, Rx only. The e360 Ventilator System is intended to provide continuous (endotracheal or tracheostomy [ET] tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients requiring tidal volumes equal to or greater than 20 milliliters (mL).

    FDA Recall
    Terminated ·Newport Medical Instruments Inc·Product code CBK·December 15, 2008

    Hamilton brand RAPHAEL Silver Ventilator (Software Version 2.2xS) Product is distributed by Hamilton Medical, Inc., 4990 Energy Way, Reno, NV 89502

    FDA Recall
    Terminated ·Hamilton Medical Inc·Product code CBK·May 24, 2006

    Hamilton brand RAPHAEL Ventilator (Software Versio 2.2x), Product is distributed by Hamilton Medical, Inc., 4990 Energy Way,Reno, NV 89502-Serial Numbers 2975 to 5360,

    FDA Recall
    Terminated ·Hamilton Medical Inc·Product code CBK·May 24, 2006

    Espirit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics

    FDA Recall
    Terminated ·Respironics California Inc·Product code CBK·June 1, 2001