BEUDAMED
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    KMA FLOW DIRECTED THERMODILUTION CATHETE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Polishers

    FDA UDI
    DFS - DIAMON GmbH·04057176151971·2comp pol. lense CA 6pcs

    HEARTLINE RETRACTOR BLADES

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896095793·HEARTLINE RETRACTOR BLADES ATRIAL SOLID

    ACUMED

    FDA UDI
    Acumed LLC·10806378045141·TRIAL Post-Lat Plates Bend Template

    BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO ENDOFAST RELIANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ACCU-CHEK ® PERFORMA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 8, 2014

    ASR UNI FEMORAL IMPL SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·October 23, 2012

    PFC CVD 10MM SZ3

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·August 10, 2010

    Exogen Express Bone Healing System, SAFHS, Part Numbers 71034200 and 71034140, Rx only, Smith & Nephew, 1450 Brooks Road, Memphis TX 38116. These are distributed internationally only. The device is used for the non-invasive treatment of established nonunions excluding skull and vertebra.

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code LPQ·June 5, 2009

    Exogen 4000+ Ultrasound Bone Healing System, SAFHS, Part Numbers 71034100 and 71034101, Rx only, Smith & Nephew, 1450 Brooks Road, Memphis TX 38116. The device is used for the non-invasive treatment of established nonunions excluding skull and vertebra.

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code LPQ·June 5, 2009

    Excelsior SL-10 Microcatheter, placed in sterile pouch. Manufactured by Boston Scientific Corporation, Fremont, CA. The ExcelsiorTM SL-10 Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQY·October 7, 2008

    Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations. The Jadak Barcode Scanner is used to scan medication labels during refill of the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations and dispensing medication for patients.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code BRY·January 15, 2016

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021