BEUDAMED
    21 results · 20ms · Sources: EU EUDAMED, US FDA

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    Air Compression Massager (Model LF-FT003)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    NA

    FDA UDI
    OPHTHALMED LLC·M735A2130001·

    Dornier MedTech

    FDA UDI
    Dornier MedTech GmbH·04049958002854·Medilas H30 Solvo Holmium Laser with wireless f...

    6PW - CPRotector® TWO Economy - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588030005·6PW - CPRotector® TWO Economy - Poly White

    MATIRA ANTERIOR CERVICAL SYSTEM

    FDA UDI
    Kalitec Direct LLC·B07307K0130001·PLATE BENDER, UNIVERSAL

    Ocata Anterior Cervical System

    FDA UDI
    Kalitec Direct LLC·B07308K0130000·Plate Bender Assembly

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K1230000·Rod Holder, Curved, 5.5 mm

    ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000

    FDA 510(k)
    FDA Class 2 ·Dental

    INTEGRA TOTAL FOOT SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520

    FDA 510(k)
    FDA Class 2 ·Neurology

    CYPHER RX DRUG-ELUTING STENT

    FDA Adverse Event
    Death ·CORDIS·Product code NIQ·August 3, 2007

    FG 6301 DUAL CHNL VOL INF PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·October 29, 2008

    STRYKER GO BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·July 12, 2011

    INCEPTA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013

    Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 440 mm, Item Number: 814511440

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 19, 2018

    MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with MEDITECH's Laboratory Information System (LIS) with Other Vendor systems to manage the transfer of patient results and demographic information.

    FDA Recall
    Terminated ·Medical Information Technology, Inc. Meditech Circle·Product code OUG·May 7, 2013

    Elekta Precise Treatment Table

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 25, 2015

    Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec 6 Plus and Tec 6 Plus NAD Variant is an electronic vaporizer which delivers the anesthetic agent desflurane. The Tec 6 Plus attaches only to Datex-Ohmeda anesthesia machines equipped with the proprietary Selectatec manifold. The Tec 6 Plus NAD Variant attaches only to NAD anesthesia machines equipped with the NAD exclusion type manifold.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·September 18, 2013

    Various products which were contract sterilized.

    FDA Enforcement
    Class II ·Ongoing·Anewmed Corporation·November 6, 2019

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017