BEUDAMED
    23 results · 22ms · Sources: EU EUDAMED, US FDA

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    YELLOW LASER PHOTOCOAGULATOR YLC-500

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04064984699540·GENUMEDI PSS BLUE SIZE II

    Walgreens

    FDA UDI
    WALGREEN CO.·00049022633100·ULTRA THIN MAXIPAD W/WINGS SUPER 32CNT

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481121920·LOCATOR F-Tx Abutment For 4.05mm Platform Exter...

    Denovo Preformed Matrix Band

    FDA UDI
    Denovo Dental, Inc.·00810059290822·Denovo Preformed Matrix Band - Pediatric 3/16, ...

    MEDLINE PVC URETHRAL CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ADHESIVE EXL-759

    FDA 510(k)
    FDA Class 2 ·Dental

    PROCEDURAL STRETCHER

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPO·June 12, 2025

    LOGIC FEMORAL PS POR RIGHT SZ 2

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·February 10, 2025

    ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS

    FDA Adverse Event
    Malfunction ·MEDIVANCE, INC. ¿ 1725056·Product code DWJ·April 17, 2026

    UNKNOWN ARCTICGEL PADS

    FDA Adverse Event
    Malfunction ·MEDIVANCE, INC. ¿ 1725056·Product code DWJ·April 17, 2026

    LOGIC CR FEMORAL POR, LEFT, SZ 3.5

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·December 11, 2024

    ROTATING MULTIPLE CLIP APPLIER

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 14, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·July 20, 2011

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·September 12, 2008

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·April 26, 2023

    Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad Kit, 31705I b) Intrepid ArcticGel Medium Pad Kit, 31707I c) Intrepid ArcticGel Large Pad Kit, 31709I d) Intrepid ArcticGel Universal Pad, 31700I e) ArcticGel Universal Pad, 31700 f) ArcticGel Universal Pad, 4-pack, 3170004 g) ArcticGel X-Small Pad, 31703 h) ArcticGel X-Small Pad, 2-pack, 3170302 i) ArcticGel Small Pad Kit, 31705 j) ArcticGel Small Pad Kit, 2-pack, 3170502 k) ArcticGel Medium Pad Kit, 31707 l) ArcticGel Medium Pad Kit, 2-pack, 3170702 m) ArcticGel Large Pad Kit, 31709 n) ArcticGel Large Pad Kit, 2-pack, 3170902 o) ArcticGel Small Universal Pad Kit, 31810 p) ArcticGel Small Universal Pad,4-pack, 3180104 q) ArcticGel Neonatal Pad Kit, 31802 (international distribution only) r) Intrepid ArcticGel Small Pad Kit, 31705I Product Usage: The Arctic Sun¿ Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature. ArcticGel Pads are used with the Arctic Sun¿ Temperature Management System to provide a hydrogel layer that ensures contact between the patient s skin and the pad throughout the treatment.

    FDA Enforcement
    Class II ·Terminated·Bard Medical Division·May 8, 2019

    BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. ArcticGel Pads are only for use with an Arctic Sun Temperature Management System Control Module.

    FDA Enforcement
    Class II ·Terminated·C.R. Bard, Inc.·April 20, 2016

    Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad Kit, 31705I b) Intrepid ArcticGel Medium Pad Kit, 31707I c) Intrepid ArcticGel Large Pad Kit, 31709I d) Intrepid ArcticGel Universal Pad, 31700I e) ArcticGel Universal Pad, 31700 f) ArcticGel Universal Pad, 4-pack, 3170004 g) ArcticGel X-Small Pad, 31703 h) ArcticGel X-Small Pad, 2-pack, 3170302 i) ArcticGel Small Pad Kit, 31705 j) ArcticGel Small Pad Kit, 2-pack, 3170502 k) ArcticGel Medium Pad Kit, 31707 l) ArcticGel Medium Pad Kit, 2-pack, 3170702 m) ArcticGel Large Pad Kit, 31709 n) ArcticGel Large Pad Kit, 2-pack, 3170902 o) ArcticGel Small Universal Pad Kit, 31810 p) ArcticGel Small Universal Pad,4-pack, 3180104 q) ArcticGel Neonatal Pad Kit, 31802 (international distribution only) r) Intrepid ArcticGel Small Pad Kit, 31705I Product Usage: The Arctic Sun Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature. ArcticGel Pads are used with the Arctic Sun Temperature Management System to provide a hydrogel layer that ensures contact between the patient s skin and the pad throughout the treatment.

    FDA Recall
    Terminated ·Bard Medical Division·Product code DWJ·November 8, 2017

    RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·January 20, 2016