BEUDAMED
    15 results · 13ms · Sources: EU EUDAMED, US FDA

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    Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnostic implant that detects the onset of an ACS event and warns the patient to seek urgent medical care. The Guardian is an adjunct to patient recognized symptoms.

    FDA Recall
    Open, Classified ·Angel Medical Systems, Inc.·Product code QBI·September 1, 2023

    WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code DQY·July 29, 2025

    WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code DQY·July 29, 2025

    WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code DQY·July 29, 2025

    WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code DQY·July 29, 2025

    Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray images of human patients. Models: 5411/ 050, A5411/ 0300 and A5411/ 0400

    FDA Recall
    Open, Classified ·Agfa N.V. Septestraat 27 Mortsel Belgium·Product code IZL·February 23, 2024

    Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), Product Code 66520; b) STERILE TOWEL CLAMP, Product Code A547ST; c) ST TOWEL CLAMPS NON PERFORATING (P/S), Product Code I68080; d) STERILE TOWEL CLAMPS 5 1/2, Product Code I68085; e) STERILE TOWEL CLAMPS 5 1/2", Product Code I68095; f) ZIPSER PENIS CLAMP STERILE (ZC110), Product Code ZC110ST

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code HXD·February 23, 2024

    LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code MXD·March 30, 2026

    LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code MXD·March 30, 2026

    Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator

    FDA Recall
    Open, Classified ·Abbott·Product code GXD·September 28, 2023

    Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code MXD·September 6, 2024

    Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover ATR.CLAMP CVD 215MM; (2) REF FB459R, Glover ATR.CLAMP CVD 245MM; (3) REF FB461R, Glover ATR.CLAMP 195MM; (4) REF FB462R, Glover ATR.CLAMP 210MM; (5) REF FB469R, Leland-Jones Peripheral CLMPSTR 195MM; (6) REF FB567R, Cooley Pediatric Clamp 30DG30/165MM; (7) REF FB568R, Cooley Pediatric Clamp 60DG 30/160MM; (8) REF FB569R, Cooley Pediatric Clamp 90DG30/150MM; (9) REF FB729R, Cooley Pediatric Clamp 17MM 170MM; (10) REF FB730R, Cooley Pediatric Clamp 20MM175MM; (11) REF FB736R, Cooley Pediatric Clamp 74MM 185MM; (12) REF FB737R, Cooley Pediatric Clamp 86MM 195MM; and (13) REF FB738R, Cooley Pediatric Clamp 108MM 260MM.

    FDA Recall
    Open, Classified ·Aesculap Inc·Product code HXD·January 31, 2025

    ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor

    FDA Recall
    Open, Classified ·Medtronic Inc.·Product code MXD·November 3, 2023

    Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only

    FDA Recall
    Open, Classified ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code MXD·May 14, 2021

    Medtronic Reveal LINQ LNQ11 / PA96000

    FDA Recall
    Open, Classified ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code MXD·June 1, 2021