BEUDAMED
    28 results · 23ms · Sources: EU EUDAMED, US FDA

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    DENTO TEMP

    FDA 510(k)
    FDA Class 2 ·Dental

    THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY

    FDA 510(k)
    FDA Unclassified ·Unknown

    RESTORATION MODULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    - Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DVT10 Standard Ref. DVT10 Lot 122570, 12546 - Calf Garment, DVT20 Large Ref. DVT20 Lot 122549, 122570 - SCD Express Compression Sleeve, Knee Length, (White) Large Ref. 9789 Lot 122574 - SCD Express Compression Sleeve, Knee Length, (White) Medium Ref. 9529 Lot 122547, 122574 - SCD Express Compression Sleeve, Thigh Length, (White) Medium Ref. 9530 Lot 122574 Compressible limb sleeve. - Thigh Garment DVT30 Medium Ref. DVT30 Lot 122549, 122985 - Thigh Garment DVT40 Large Ref. DVT40 Lot 122549, 122985 - Vaso-Force Intermittent DVT Calf Garment, Large, Calf Sizes up to 24" 24" Ref. MDS601L Lot 122982, 122986 - Vaso-Force Intermittent DVT Calf Garment, Medium, Calf Sizes up to 18" 18" Ref. MDS601M Lot 122986, 122984 - VENAFLOW Calf Cuff, w/Foam (White) 19" Max. Calf Circumference Ref. 3010-PL Lot 122692, 122715

    FDA Enforcement
    Class II ·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·March 8, 2013

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·December 12, 2012

    - Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DVT10 Standard Ref. DVT10 Lot 122570, 12546 - Calf Garment, DVT20 Large Ref. DVT20 Lot 122549, 122570 - SCD Express Compression Sleeve, Knee Length, (White) Large Ref. 9789 Lot 122574 - SCD Express Compression Sleeve, Knee Length, (White) Medium Ref. 9529 Lot 122547, 122574 - SCD Express Compression Sleeve, Thigh Length, (White) Medium Ref. 9530 Lot 122574 Compressible limb sleeve. - Thigh Garment DVT30 Medium Ref. DVT30 Lot 122549, 122985 - Thigh Garment DVT40 Large Ref. DVT40 Lot 122549, 122985 - Vaso-Force Intermittent DVT Calf Garment, Large, Calf Sizes up to 24" 24" Ref. MDS601L Lot 122982, 122986 - Vaso-Force Intermittent DVT Calf Garment, Medium, Calf Sizes up to 18" 18" Ref. MDS601M Lot 122986, 122984 - VENAFLOW Calf Cuff, w/Foam (White) 19" Max. Calf Circumference Ref. 3010-PL Lot 122692, 122715

    FDA Recall
    Terminated ·Surgical Instrument Service And Savings, Inc.·Product code JOW·May 3, 2013

    ROD, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·December 20, 2012

    5.5 TI CANNULATED TRANSLATION SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019

    LTV

    FDA Adverse Event
    Injury ·CAREFUSION 203, INC·Product code CBK·May 17, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 13, 2011

    ILIAC SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MNH·October 16, 2019

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·March 14, 2013

    POLARIS SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·January 8, 2020

    SUPRA VERITAS BILIARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·December 20, 2012

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·December 28, 2012

    NEEDLE, HYPODERMIC, SINGLE LUMEN

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·September 1, 2020

    TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·August 28, 2018