BEUDAMED
    15 results · 27ms · Sources: EU EUDAMED, US FDA

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    REGULAR AND WIDE SKIN STAPLES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE)

    FDA 510(k)
    FDA Unclassified ·Unknown

    SonoSite SII Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNKNOWN_OSTEOSYNTHESIS_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER TRAUMA SELZACH·Product code HWC·April 21, 2014

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·September 26, 2012

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORP·Product code LGW·July 15, 2010

    FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR

    FDA Adverse Event
    Death ·FRESENIUS HEMOCARE GMBH·Product code LKN·August 21, 2023

    FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR

    FDA Adverse Event
    Death ·FRESENIUS HEMOCARE GMBH·Product code LKN·August 21, 2023

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code NEW·October 25, 2024

    Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.

    FDA Recall
    Terminated ·Product code JWH·November 15, 2016

    Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant

    FDA Recall
    Terminated ·Product code JWH·September 19, 2016

    Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diathermy 400 units. For the clinical application of electromagnetic energy in the radio frequency of 27.12 megahertz to generate deep heat within body tissues.

    FDA Recall
    Terminated ·DJO, LLC·Product code IMJ·August 21, 2015

    3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.

    FDA Recall
    Terminated ·Product code JWH·May 31, 2017

    3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 01 The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.

    FDA Recall
    Terminated ·Product code JWH·May 31, 2017

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025