BEUDAMED
    168 results · 13ms · 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 ×

    JariTrak Table Clamp, 1 inch diameter, vertical post, Catalog Number 206-160. The JariTrak Table Clamp with vertical post (206-160) is part of the Table Mounted Hardware that is used with the JariTrak™ Retractor System. The JariTrak™ self-retaining retractor system consists of the Table Clamp with Vertical Post, Flexible or Horizontal Bar with Universal Joint, Oval or Segment Rings, Tilting Blade Clamps and various blades. The product is supplied non-sterile and may be packaged individually or as part of the JariTrak™ retractor set.

    FDA Recall
    Terminated ·J. Jamner Surgical Instruments, Inc.·Product code KDC·November 14, 2006

    AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed growth pattern, however, this category is generally attached to the patients upper and lower molars or bicuspids by means of temporary stainless steel crowns or orthodontic bands. Retainer, Screw Expansion, Orthodontic.

    FDA Recall
    Terminated ·Sybron Dental Specialties·Product code DYJ·June 6, 2013

    Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL

    FDA Recall
    Terminated ·Brius Technologies Inc.·Product code DYJ·February 7, 2022

    Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and Hi-Flow Portable oxygen unit.

    FDA Recall
    Terminated ·Caire, Inc.·Product code BYJ·October 23, 2007

    Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL

    FDA Recall
    Terminated ·Brius Technologies Inc.·Product code DYJ·February 7, 2022

    CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit

    FDA Recall
    Terminated ·Caire, Inc.·Product code BYJ·October 10, 2022

    CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit

    FDA Recall
    Terminated ·Caire, Inc.·Product code BYJ·October 10, 2022

    AdvanSync is an orthodontic device intended for the orthodontic treatment of Class II malocclusions. The AdvanSync part numbers and lot numbers affected by this recall are as follows: Part Number: 600-4000 (Kits-include 10 Right 600-4000 and 10 Left Assemblies). Lot Numbers: 070990588, 070976869, 060971515, 060971514, 04094278D Part Number: 600-4040 (5-Pack, Left Assembly). Lot Numbers: 080901333, 080902356, 070981416, 060971299, 060976084 Part Number: 600-4041 (5-Pack, Right Assembly). Lot Numbers: 080902357, 080901335, 070981417, 060971304, 060976079

    FDA Recall
    Terminated ·Ormco Corporation·Product code DYJ·October 2, 2009

    CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit

    FDA Recall
    Terminated ·Caire, Inc.·Product code BYJ·October 10, 2022

    AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Removable functional orthodontic appliances that are to modify the growth of the jaws in a prescribed growth pattern.

    FDA Recall
    Terminated ·Allesee Orthodontic Appliances·Product code DYJ·February 24, 2014

    Precision Medical- Easy Mate Portable Liquid Oxygen System (container), PM22010 Series, Model number 2201, Precision Medical, Inc., Northampton, PA 18067

    FDA Recall
    Terminated ·Precision Medical, Inc.·Product code BYJ·October 4, 2006

    Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL

    FDA Recall
    Terminated ·Brius Technologies Inc.·Product code DYJ·February 7, 2022

    CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit

    FDA Recall
    Terminated ·Caire, Inc.·Product code BYJ·October 10, 2022

    MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniTorr 10102 10-102 CSF Drainage System w/Patient Line One Way Valve w MoniTorr 10110 10-110 CSF Drainage System used with Pole Mount System MoniTorr 10140 10-140 CSF Drainage System w/Vinyl Measuring Strip MoniTorr 10150 10-150 CSF Drainage System Simple Bag and Line MoniTorr 10110A 10-110A CSF Drainage System w/o Manifold Stopcock MoniTorr SP0017 SP0017 Special EVD 10-110 w/o Y Site Latex Free Sites MoniTorr SP0042 SP0042 Special EVD 10-100 w/o Y Site MoniTorr SP0090 SP0090 Special EVD 10-110 w/o Y Site MoniTorr SP0164 SP0164 Special EVD 10-140 w/Y Site & Stopcock Reverse MoniTorr SP0236 SP0236 INS 1100 WITH NEEDLE AT Y-ACCESS AND NEEDLELESS SI Product Usage: The MoniTorr ICP External CSF Drainage and Monitoring Systems provide a simple to use, closed system for the drainage of cerebrospinal fluid (CSF) from ventricles of the brain or the lumbar subarachnoid space to a drainage bag. The system may be used with a pole mounted assembly that allows for simple, quick and accurate alignment with the patient and secure positive or negative pressure level setting. The system also has been designed to provide for ease of patient transport through a compact design and antimicrobial hydrophobic vent feature that resists occlusion. Indications: The MoniTorr ICP system allows for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF inpatients with infected CSF shunts, and to monitor ICP.

    FDA Enforcement
    Class I ·Terminated·Integra LifeSciences Corp.·May 29, 2019

    VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014.

    FDA Enforcement
    Class II ·Terminated·INNOKAS MEDICAL OY·February 4, 2015

    Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finland Oy Made in US Rx Only The GE Healthcare Multi Absorber Original, Disposable is a disposable product intended for use with the GE Healthcare Advanced Breathing System (later ABS), the GE Healthcare EZchange manifold, the GE Healthcare Compact Block, and the GE Healthcare Compact Block II (later Compact Block). The Multi Absorber should only be used with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane. The device is intended to be used under constant attention of qualified professional healthcare personnel.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·December 25, 2013

    1.5 mm Inion CPS, Burrhole plate, REF PLT-1011, sterile, Manufacturer, INION Oy, Finland.

    FDA Recall
    Terminated ·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010

    2.0 mm Inion CPS, 4 hole plate, REF PLT-1013, sterile, Manufacturer, INION Oy, Finland.

    FDA Recall
    Terminated ·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010

    1.5 mm Inion CPS, 20 hole plate, REF PLT-1007, sterile, Manufacturer, INION Oy, Finland.

    FDA Recall
    Terminated ·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010

    2.0 mm Inion CPS, 6 hole plate, REF PLT-1038, sterile, Manufacturer, INION Oy, Finland.

    FDA Recall
    Terminated ·Stryker Craniomaxillofacial Division·Product code JEY·April 14, 2010