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

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    MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    APOLLO

    FDA UDI
    Conmed Corporation·20653405051609·APOLLO PAPILLOTOME

    TruLock

    FDA UDI
    Rmo, Inc.·00885797648006·TRULOCK Light Activated Adhesive Mini Kit (1ea ...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450391037·

    NA

    FDA UDI
    STRYKER CORPORATION·07613327051582·Storz Light Source Adapter

    MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA

    FDA 510(k)
    FDA Class 2 ·Neurology

    SPLINE DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    HEMICAP/UNICAP RESURFACING PROSTHESIS

    FDA Adverse Event
    Other ·ARTHROSURFACE, INC.·Product code HSD·December 7, 2012

    TIBIAL COMP,SINGLECOATED US VERSION, MEDIUM

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code NTG·April 25, 2016

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 10, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 31, 2011

    BREAST IMPLANTS

    FDA Adverse Event
    Injury ·Product code FWM·May 20, 2008

    2.7 DEGREE ANGLED SAGITAL SAW

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·November 21, 2019

    2.7 DEGREE ANGLED SAGITAL SAW

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·November 21, 2019

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018