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

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    BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743588·LEVAMED ANKLE SUPPORT SAND I

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0120110·Assembly, Screwdriver, Polyaxial, Cannulated, L...

    EYE SENTIAL

    FDA UDI
    FGX INTERNATIONAL INC.·00193033444726·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450307694·

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 24, 2019

    True Position®

    FDA UDI
    ATLAS SPINE, INC.·M68112080128110·28mm x 11mm Lordotic Spacer

    ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY

    FDA 510(k)
    FDA Class 2 ·Dental

    PERC-D SPINEWAND

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Octane Straight PC

    FDA UDI
    Choice Spine, LP·10885862277978·

    Octane Straight

    FDA UDI
    Choice Spine, LP·10885862235879·

    TOTAL ASR FEM IMP SIZE 53

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KXA·March 20, 2013

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Injury ·INVACARE·Product code FNL·March 1, 2011

    ABS2000

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·March 17, 2008

    INDIGO SYSTEM SEPARATOR 8

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code DXE·June 28, 2019

    Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 2014

    Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07, & ME14. 510(k) K012812 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.

    FDA Recall
    Terminated ·Terumo Medical Corporation·Product code DYB·June 24, 2010

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012