BEUDAMED
    23 results · 22ms · 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 Regulation: Us FDA ×

    SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ATLANTIS® Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994239969·SCREW 3120211 4.0 X 11 SELF TAP FIX

    Unity Total Knee System

    FDA UDI
    CORIN LTD·05056139243486·UNITY KNEE™ PS-C INSERT - Size 2 x 11mm

    ATLANTIS® Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000889340·SCREW 3120211 4.0 X 11 SELF TAP FIX

    DURAVENT

    FDA UDI
    Andreas Fahl Medizintechnik-Vertrieb GmbH·04051948006896·DURAVENT XL 2 IC, SIZE 11

    Cortical Screw, Cannulated

    FDA UDI
    I.T.S. GmbH·09120069816112·Cortical Screw, Cannulated, D=2.0mm, L=11mm

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113089·PS Insert, Size 2 x 11mm

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946026875·X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LE...

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946060817·X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LE...

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK1200110·Rod Gripper, 5.50mm Angled

    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12T/12PI (Custom Pressure Monitoring Kit), REF: K12-03846 K12-04185A K12-03447 K12M-02489 K12-10056 K12-02489A K12-02097B K12-12335 K12-12192P K12-12079P K12-04262BP K12-11132B K12-12382 K12-09098C K12-02112 K12-02111 K12-05576G K12-05805A K12T-10313C K12-11821P K12-01348D K12-11821 K12-11426 K12-06318 K12-12053 K12-03438 K12-07208A K12-12147 K12-09009 K12-10375 K12-08716 K12-11669AP K12-00657A K12-11131AP K12-10914 K12-07299P K12-05494 K12-00443A K12-08303 K12-06509A K12-10962 K12-11133 K12-06509B To support various vascular or cardiac diagnostic and interventional procedures.

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·August 21, 2024

    PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BODY FORCE, MODEL BT 6000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD FILTER BLUNT FILL NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·April 27, 2023

    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12T/12PI (Custom Pressure Monitoring Kit), REF: K12-03846 K12-04185A K12-03447 K12M-02489 K12-10056 K12-02489A K12-02097B K12-12335 K12-12192P K12-12079P K12-04262BP K12-11132B K12-12382 K12-09098C K12-02112 K12-02111 K12-05576G K12-05805A K12T-10313C K12-11821P K12-01348D K12-11821 K12-11426 K12-06318 K12-12053 K12-03438 K12-07208A K12-12147 K12-09009 K12-10375 K12-08716 K12-11669AP K12-00657A K12-11131AP K12-10914 K12-07299P K12-05494 K12-00443A K12-08303 K12-06509A K12-10962 K12-11133 K12-06509B To support various vascular or cardiac diagnostic and interventional procedures.

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code OEQ·June 11, 2024

    UNKNOWN PRODUCT - SET SCREW

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HWC·October 12, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·May 20, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 26, 2014

    LIGAMAX- CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 10, 2011

    BD NEEDLE FILTER BLUNT FILL

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·November 22, 2021