BEUDAMED
    49 results · 51ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    MICRO-ACCESS TEARAWAY INTRODUCER KIT

    FDA Adverse Event
    Malfunction ·GALT MEDICAL CORP·Product code OFL·February 10, 2023

    MICRO-INTRODUCER KIT

    FDA Adverse Event
    Injury ·GALT MEDICAL CORPORATION·Product code OGF·June 3, 2022

    6F HYDROPHILIC GALTSTICK INT KIT

    FDA Adverse Event
    Injury ·GALT MEDICAL CORPORATION·Product code DQX·July 6, 2021

    FLUENT TRANSITIONLESS STIFFEN MICRO-INTRODUCER KIT

    FDA Adverse Event
    Injury ·GALT MEDICAL CORPORATION·Product code DQX·May 2, 2019

    GUIDEWIRE IN DISPENSER

    FDA Adverse Event
    Injury ·GALT MEDICAL CORPORATION·Product code DQX·January 16, 2023

    FLUNET TRANSITIONLESS STIFFEN MICRO-INTRODUCER KIT 4F

    FDA Adverse Event
    Injury ·GALT MEDICAL CORPORATION·Product code DYB·February 21, 2019

    MICRO-INTRODUCER KIT

    FDA Adverse Event
    Malfunction ·GALT MEDICAL CORPORATION·Product code DQX·February 24, 2021

    Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46

    FDA Recall
    Terminated ·Galt Medical Corporation·Product code DYB·May 2, 2018

    GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.

    FDA Recall
    Terminated ·Galt Medical Corporation·Product code DYB·July 25, 2014

    Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,

    FDA Recall
    Terminated ·Galt Medical Corporation·Product code KGZ·May 2, 2018

    Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055

    FDA Recall
    Terminated ·Galt Medical Corporation·Product code DYB·May 2, 2018

    B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the vascular system following a small gauge needle stick.

    FDA Recall
    Open, Classified ·Galt Medical Corporation·Product code DRE·March 27, 2025

    Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk)

    FDA Recall
    Open, Classified ·Galt Medical Corporation·Product code DYB·May 8, 2023

    Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553 KIT-011-62, 00841268105614 KIT-038-04, 00841268104556 KIT-039-03, 00841268104587 KIT-039-13, 00841268106055 KIT-081-02 / PS2-38, 00841268108394 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the peripheral vascular system following a small gauge needle stick.

    FDA Recall
    Open, Classified ·Galt Medical Corporation·Product code OFL·March 27, 2025

    1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-002-02, b) DRC-002-05, c) DRC-002-06, d) DRC-002-08,

    FDA Recall
    Terminated ·Galt Medical Corporation·Product code KGZ·May 2, 2018

    GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral vasculature.

    FDA Recall
    Open, Classified ·Galt Medical Corporation·Product code DQX·March 27, 2025

    Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16

    FDA Recall
    Open, Classified ·Galt Medical Corporation·Product code DYB·May 8, 2023

    TVS LPA, Catalog #: DIL-059-00

    FDA Recall
    Terminated ·Galt Medical Corporation·Product code KGZ·May 2, 2018

    1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11; 2) Enhance Transcarotid/Peripheral Access Kit, Sterile EO, Rx Only, Catalog #: a) KIT-075-02; b) KIT-075-03

    FDA Recall
    Terminated ·Galt Medical Corporation·Product code DRE·May 2, 2018

    1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilator, Sterile EO, Rx Only, Catalog #: DIL-600-11; 3) Tearaway Introducer, Sterile EO, Rx Only, Catalog #: a) INT-028-14; b) INT-028-24; c) INT-029-05; d) INT-106-01; e) INT-106-14; 4) Micro-Access Tearaway Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-010-14; 5) Mini Tear Away Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-027-04; 6) LI-11 Plus G, Sterile EO, Catalog #: KIT-042-11; 7) LI-12 Plus G, Sterile EO, Catalog #: KIT-042-12; 8) Micro-Access Tearaway Introducer Kit, Sterile EO, Catalog #: a) KIT-900-13; b) KIT-900-14; c) KIT-900-17; d) KIT-900-29; e) KIT-901-02; f) KIT-901-02; 9) "Micro-Access" Kit, Sterile EO, Catolog #: KIT-900-88 10) Mini Stick II Microintroducer Kit. Sterile EO, Rx Only, Catalog #: a) KIT-045-05; b) KIT-045-15;

    FDA Recall
    Terminated ·Galt Medical Corporation·Product code DYB·May 2, 2018