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

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    HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.

    FDA Enforcement
    Class II ·Terminated·Ethicon Endo-Surgery Inc·November 25, 2015

    1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humification of ventilator-dependent and non-ventilator dependent patients in critical care, home care and anesthesia.

    FDA Enforcement
    Class II ·Terminated·AB ULAX·October 14, 2020

    Medtronic Sofamor Danek Bone fragmentor Ref Number/Model # 9150111

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code LYS·October 20, 2006

    Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories Ltd.·February 12, 2020

    Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493919308200 EMERGE MR, OUS 2.00mm X 8mm; 2. REF/Catalog No. H7493918912200, EMERGE MR US 2.00MM X 12MM; 3. REF/Catalog No. H7493919312200, EMERGE MR, OUS 2.00mm X 12mm; 4. REF/Catalog No. H7493918912250, EMERGE MR US 2.50MM X 12MM; 5. REF/Catalog No. H7493919312250, EMERGE MR, OUS 2.50mm X 12mm; 6. REF/Catalog No. H7493918912300, EMERGE MR US 3.00MM X 12MM; 7. REF/Catalog No. H7493919312300, EMERGE MR, OUS 3.00mm X 12mm; 8. REF/Catalog No. H7493918915150, EMERGE MR US 1.50MM X 15MM; 9. REF/Catalog No. H7493919315150, EMERGE MR, OUS 1.50mm X 15mm; 10. REF/Catalog No. H7493918915200, EMERGE MR US 2.00MM X 15MM, 11. REF/Catalog No. H7493919315200, EMERGE MR, OUS 2.00mm X 15mm; 12. REF/Catalog No. H7493919315250, EMERGE MR, OUS 2.50mm X 15mm; 13. REF/Catalog No. H7493918915300, EMERGE MR US 3.00MM X 15MM; 14. REF/Catalog No. H7493919315300, EMERGE MR, OUS 3.00mm X 15mm; 15. REF/Catalog No. H7493918915350, EMERGE MR US 3.50MM X 15MM; 16. REF/Catalog No. H7493919315350, EMERGE MR, OUS 3.50mm X 15mm; 17. REF/Catalog No. H7493919320200, EMERGE MR, OUS 2.00mm X 20mm; 18. REF/Catalog No. H7493919320250, EMERGE MR, OUS 2.50mm X 20mm; 19. REF/Catalog No. H7493919320300, EMERGE MR, OUS 3.00mm X 20mm; 20. REF/Catalog No. H7493919415120, EMERGE PUSH MR, OUS 1.20mm X 15mm.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·December 4, 2019

    ThermaSure Medical Device Drying Cabinet, series 300

    FDA Recall
    Terminated ·Cenorin·Product code LDS·December 21, 2006

    ThermaSure Medical Device Drying Cabinet, series 1000

    FDA Recall
    Terminated ·Cenorin·Product code LDS·December 21, 2006

    ThermaSure Medical Device Drying Cabinet, series 130

    FDA Recall
    Terminated ·Cenorin·Product code LDS·December 21, 2006

    ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·October 24, 2018

    Arrow Double-Lumen Balloon Wedge Pressure Catheter, for sampling blood for oxygen levels and measuring pressures in the right heart.

    FDA Recall
    Terminated ·Arrow International Inc·Product code NVM·June 20, 2006

    BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system, bioMerieux, Inc., P. O. Box 15969, Durham, NC 27704-0969 USA

    FDA Recall
    Terminated ·bioMerieux, Inc.·Product code MDB·December 19, 2006

    FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only

    FDA Enforcement
    Class III ·Terminated·Biofire Defense·March 11, 2020

    Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for postdilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

    FDA Enforcement
    Class II ·Terminated·Cordis Corporation·November 14, 2018

    Eridan Automated Slide Stainer and Support Cart, REF E300 and E300SC1, Dako Colorado, Inc. (Catalog No. (ER 00130,00331,00230,00431)

    FDA Recall
    Terminated ·Dako Colorado, Inc.·Product code KPA·October 2, 2006

    3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 10 electrodes per card; 4 cards per pouch; 20 pouches per shipper box (800 electrodes total).

    FDA Enforcement
    Class II ·Terminated·3M Company - Health Care Business·November 11, 2020

    Galileo Femoral Clamp TKR Slim, Model Number: SYS25 1226

    FDA Recall
    Terminated ·Plus Orthopedics USA·Product code HAW·June 20, 2006

    Wallstent Endoscopic Biliary Endoprosthesis 8mm x 60mm, UPN H965430200

    FDA Recall
    Terminated ·Boston Scientific Corporation One Boston·Product code FGE·December 20, 2006

    Veris Invasive Blood Pressure Interface Cables-Part # 3010478. The product is an accessory to patient physiological monitor.

    FDA Recall
    Terminated ·Medrad Inc·Product code MWI·September 29, 2006

    Wallstent Endoscopic Biliary Endoprosthesis- 8mm x 40mm, UPN H965430100

    FDA Recall
    Terminated ·Boston Scientific Corporation One Boston·Product code FGE·December 20, 2006

    Wallstent Endoscopic Biliary Endoprosthesis 10mm x 60mm, UPN H965430500

    FDA Recall
    Terminated ·Boston Scientific Corporation One Boston·Product code FGE·December 20, 2006