BEUDAMED
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    PILONPLATE WITH ANGULAR STABILITY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193103372·HA PEEK EVOS Curved, , 11mmx10mmx 26mm , FLAT 0...

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809841749·FOR MEN 15-20 MM HG KNEE HIGH CLOSED TOE EXTRA ...

    Valencia Pedicle Screw System

    FDA UDI
    Altus Spine, LLC·00843210134574·T-25 Tapered Inserter

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0120110·Assembly, Screwdriver, Polyaxial, Cannulated, L...

    UNK

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC.·Product code KNS·June 13, 2014

    MODIFICATION TO A620 EEG

    FDA 510(k)
    FDA Class 2 ·Neurology

    GLUTARTEST 1 REAGENT STRIP

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BD BACTEC¿ MGIT¿ 960 PZA KIT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·December 27, 2022

    BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·June 25, 2024

    BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·April 8, 2025

    RESOLUTE INTEGRITY RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·April 11, 2013

    SETROX S 53

    FDA Adverse Event
    Malfunction ·BIOTRONIK MBH AND CO.·Product code DTB·May 21, 2008

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 12, 2011

    MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·March 26, 2025

    DeRoyal (R) ST. Circumcision Clamp, REF 32-1622, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Circumcision Clamp

    FDA Recall
    Terminated ·Deroyal Industries, Inc. Lafollette·Product code HFX·May 5, 2011

    Circumcision trays and packs listed as follows: (1) DeRoyal (R) ST. Circumcision Tray, REF 50-5613, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Made in Dominican Republic Lot Numbers: 20854003, 22892644 (2) DeRoyal (R) ST. Circumcision PACK 1.3 CLAMP CLAMPMEMORIAL HEALTH, MEMORIAL HOSP TAL WEST, REF 89-5699, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Number 20012949 Circumcision Clamp

    FDA Recall
    Terminated ·Deroyal Industries, Inc. Lafollette·Product code HFX·May 5, 2011

    Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories.

    FDA Recall
    Terminated ·Medtronic, Inc. Neuromodulation·Product code LKK·July 5, 2011

    Philips BV Endura, Rel. 2, 718074. Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications.

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code IXL·December 14, 2010

    Philips BV Pulsera, Rel. 2.3, 718095. Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications.

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code IXL·December 14, 2010