BEUDAMED
    21 results · 22ms · Sources: EU EUDAMED, US FDA

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    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526827905·ACHIMED ACHILLES SUPP BLACK II

    MTI ST#1 SILICONE PESSARY

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Channels

    FDA UDI
    HENRY SCHEIN, INC.·10304040160395·ChannelsOne 21mm Large

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717106842·Paper Points, Taper .04, Size #30, 100pcs/box

    APC™ II Unitek™ Mini Uni-Twin

    FDA UDI
    3M UNITEK CORPORATION·00652221062246·Mini Uni-Twin(TM) Bracket APC(TM) II Standard E...

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837051099·Plateau-P, Bulleted, 5 Degree, 12mm x 20mm

    LOCKING SCREWS, CROSS-PIN, DIAM.2.0X12MM, (5/PACKAGE)

    FDA Adverse Event
    Malfunction ·STRYKER LEIBINGER FREIBURG·Product code JEY·December 8, 2014

    OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TORAYSULFONE DIALYZER

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

    WEB SL

    FDA Adverse Event
    Injury ·MICROVENTION, INC.·Product code OPR·April 13, 2022

    WEB SL

    FDA Adverse Event
    Injury ·MICROVENTION, INC.·Product code OPR·April 13, 2022

    SIGMA STAB XLK INS 4 15MM

    FDA Adverse Event
    Injury ·9616671 DEPUY (IRELAND)·Product code JWH·March 26, 2013

    C-TAPER TRIAL HEAD 36MM +10

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·February 16, 2011

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·May 31, 2007

    Replacement screw non-springloaded traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion, Boss Instruments, Millennium Surgical, Prezio Health, and Stealth Surgical brand names.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·December 17, 2014

    Titanium fixation screws, springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the Millennium Surgical, Boss Instruments, Stealth Surgical, and CareFusion brand names.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·December 17, 2014

    Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the Millenium Surgical, Echo Instruments, Adler Instrument, Surgical Direct, Stealth Surgical, CareFusion, and Boss Instruments brand names.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·December 17, 2014

    Traction tong replacement screws, non-springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Boss Instruments, and Stealth Surgical brand names.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·December 17, 2014

    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·October 8, 2014

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021