BEUDAMED
    22 results · 26ms · Sources: EU EUDAMED, US FDA

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    Oculus Pentacam AXL Wave, Ref 70020, CE 0123

    FDA Recall
    Open, Classified ·Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany·Product code MXK·August 8, 2023

    Pentacam HR REF 70900. Used to image the anterior segment of the eye.

    FDA Recall
    Open, Classified ·Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany·Product code MXK·July 8, 2022

    Oculus Pentacam AXL , Ref 70100, CE 0123

    FDA Recall
    Open, Classified ·Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany·Product code MXK·August 8, 2023

    Oculus Myopia Master , Ref 68100, CE 0123

    FDA Recall
    Open, Classified ·Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany·Product code MXK·August 8, 2023

    Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.

    FDA Recall
    Open, Classified ·Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany·Product code MXK·July 8, 2022

    Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.

    FDA Recall
    Open, Classified ·Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany·Product code MXK·July 8, 2022

    OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany. The Pentacam AXL is designed to take photos of the anterior segment of the eye, which includes the cornea, pupil, anterior chamber, and lens of the eye, to evaluate corneal shape, analyze condition of the lens (opaque crystalline lens), analyze the anterior chamber angle, analyze anterior chamber depth, analyze the volume of the anterior chamber, analyze anterior or posterior cortical opacity, analyze the location of cataracts (nuclear, sub capsular and/or cortical), using cross slit imaging with densitometry, corneal thickness, axial length, and white-to-white distance. The Pentacam AXL also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.

    FDA Recall
    Terminated ·Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany·Product code MXK·November 21, 2017

    Kit BD Max ExK TNA 2; Catalog # 442825

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code JJH·July 17, 2019

    Kit BD Max ExK DNA 1 USA; Catalog # 442817

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code JJH·July 17, 2019

    Kit BD Max ExK DNA 2 USA; Catalog # 442819

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code JJH·July 17, 2019

    Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code N/A·July 17, 2019

    Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code N/A·July 17, 2019

    Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.

    FDA Recall
    Terminated ·Karl Storz Endoscopy·Product code EQN·December 6, 2019

    M.K. WITH 03ML FLUSH DEVICE FOR DRISCOLL FOUNDATION CHILDRENS HOSP., Item No. 46068-02 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DRS·September 27, 2016

    AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle

    FDA Recall
    Terminated ·Aesculap Implant Systems LLC·Product code HXK·September 25, 2019

    HealthPax Cranial Electrotherapy Stimulator

    FDA Recall
    Terminated ·Health Directions, Inc·Product code JXK·July 19, 2007

    CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Arco Electronics Limited, Distributed by Neuro-Fitness LLC, Fall City, Washington 98024

    FDA Recall
    Terminated ·Neuro-Fitness LLC·Product code JXK·October 29, 2007

    Offset Wire Fixation Bolt, catalog number 8180-50-006. The bolts are used with the DePuy Ace-Fischer External Fixation System and are packaged in a flexible polyethylene bag.

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code HXK·November 8, 2011

    Speed Stitch Needle Cassette

    FDA Recall
    Open, Classified ·ArthroCare Corporation·Product code HXK·August 17, 2020

    Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610

    FDA Recall
    Open, Classified ·Aesculap Implant Systems LLC·Product code HXK·May 18, 2023