BEUDAMED
    15 results · 24ms · 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.

    630C ELECTROCARDIOGRAPH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Signature

    FDA UDI
    SILEX MEDICAL, LLC·B3315863030·Locking Stone Cup Grasping Forceps

    Signature

    FDA UDI
    SILEX MEDICAL, LLC·B33158630300·Stone Cup Grasping Forceps

    Signature

    FDA UDI
    SILEX MEDICAL, LLC·B331586303045·Locking Long Stone Cup Grasping Forceps

    Needle Holder

    FDA UDI
    KATENA PRODUCTS, INC.·00841668108253·BARRAQUER NEEDLE HOLDER CURVED

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867125810·HEADLESS COMPRES SCRW 3.0X30MM

    THE BIO-TEK CHROMOSCAN

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    COMFORT SCOOTER MODEL LY-EW406

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863030.

    FDA Enforcement
    Class II ·Ongoing·Silex Medical, LLC·June 11, 2025

    EQUINOXE ANATOMIC REPLICATOR PLATE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·June 6, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 9, 2010

    POWERMAX ELITE HANDPIECE

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW OKLAHOMA CITY MANUFACTURING SITE·Product code HRX·December 10, 2012

    COMPREHENSIVE REVERSE SHOULDER MEDIUM AUGMENTED BASEPLATE W/ MINI TAPER ADAPTER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·August 23, 2024

    Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863030.

    FDA Recall
    Open, Classified ·Silex Medical, LLC·Product code GEI·January 9, 2024

    Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733 178734 178735 178354S 178754 178755 178756 178757 178758 178759 Product Usage: 1) Correction of revision of unsuccessful osteotomy, arthrodesis or previous joint replacement 2) Tumor resections 3) Revision of previously failed total joint arthroplasty 4) Trauma The ComPreSs Distal Femoral Replacement System is intended for uncemented use.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019