BEUDAMED
    3,361 results · 28ms · Sources: EU EUDAMED, US FDA

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    ORALPAK 5ML COLS ADAP16 BLS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code KYX·March 12, 2020

    COL TB CLASSIC/EXTRA CLEAN

    FDA Adverse Event
    Injury ·COLGATE SANXIAO CO., LTD.·Product code EFW·December 27, 2022

    COL TB CLASSIC/EXTRA CLEAN

    FDA Adverse Event
    Injury ·COLGATE-PALMOLIVE COMPANY (VIETNAM) LTD - MY PHUOC·Product code EFW·May 19, 2026

    CORAIL AMT SZ11 STD COL

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code MEH·January 15, 2026

    COL TB 360 LUMINOUS WHITE

    FDA Adverse Event
    Injury ·Product code EFW·March 30, 2018

    CORAIL AMT SZ12 LOW COL

    FDA Adverse Event
    Injury ·DEPUY FRANCE SAS - 3003895575·Product code LZO·March 23, 2021

    COL TB 360 OPTIC WHITE

    FDA Adverse Event
    Injury ·Product code EFW·April 10, 2018

    COL TB CLASSIC/EXTRA CLEAN

    FDA Adverse Event
    Injury ·COLGATE PALMOLIVE COMPANY·Product code EFW·March 19, 2022

    COL PTB 360 SONIC CHARCOAL

    FDA Adverse Event
    Injury ·COLGATE PALMOLIVE COMPANY·Product code JEQ·February 8, 2022

    COL TB SLIM SOFT CHARCOAL

    FDA Adverse Event
    Injury ·COLGATE SANXIAO CO., LTD.·Product code EFW·January 25, 2022

    COL TB CLASSIC/EXTRA CLEAN

    FDA Adverse Event
    Injury ·Product code EFW·July 15, 2019

    Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; b) TRAY FOL LATX UM COUD 16FR MF, REF DYND150216CS; c) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S; d) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S; e) TRAY FOL LATX UM COUD 18FR MF, REF DYND150218CS; f) TRAY FOLEY LTX 18FR 10ML UM MF, REF DYND150218S; g) TRAY FOLEY LTX 18FR 10ML UM MF, REF DYND150218S; h) TRAY FOLEY SIL 16FR 10ML W/UM, REF DYND150816; i) TRAY FOL SIL UM COUD 16FR MF, REF DYND150816CS; j) TRAY FOL SIL 16FR 10ML W/UM MF, REF DYND150816S; k) TRAY FOL SIL UM COUD 18FR MF, REF DYND150818CS; l) TRAY FOL SIL 18FR 10ML W/UM MF, REF DYND150818S

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·October 30, 2024

    Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DRIVE

    FDA Adverse Event
    Death ·NANTONG SHUNLONG PHYSICAL THERAPY EQUIPMENT CO., L·Product code FNL·July 5, 2023

    DRIVE

    FDA Adverse Event
    Malfunction ·NANTONG SHUNLONG PHYSICAL THERAPY EQUIPMENT CO., L·Product code FNL·July 5, 2023

    DRIVE

    FDA Adverse Event
    Malfunction ·NANTONG SHUNLONG PHYSICAL THERAPY EQUIPMENT CO., L·Product code OSI·June 15, 2023

    MEDICAL ACTION INDUSTIRES

    FDA Adverse Event
    Malfunction ·JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO.,L·Product code GDY·May 25, 2017

    Irrigation set for RTUP / Laser - 2 spikes + line fiber laser cooling

    FDA UDI
    Promepla·03700512901525·

    DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp Cooling System User Manual (PN: 0P1DDCD01M-EN_C / IFU 20190325-06-EN), DigniCap Delta Scalp Cooling Wrap (LAB 20190221-05-EN), DigniCap Delta Small Cooling Wrap (LAB 20200616-01-EN, Quick Reference Guide DigniCap Delta (IFU-20190327-02-EN), The DigniCap Scalp Cooling System Training Guide- Global (TR-20200104-05-EN), The DigniCap Scalp Cooling System Training Guide TR-2019-0801-05-US, DigniCap Delta Procedural Expectations- Global (TR-20191028-03-EN), DigniCap Delta Procedural Expectations TR- 20190721-02-US, DigniCap Delta Small Wrap Protocol Global(TR-20200728-02-EN), DigniCap Delta Small Wrap Protocol TR-20200714-01-US, DigniCap Delta Training Tips Global (TR-20200420-04-EN), DigniCap Delta Training Tips TR-20191202-05-US,

    FDA Recall
    Terminated ·Dignitana, Inc.·Product code PMC·November 5, 2021

    DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp Cooling System User Manual (PN: 0P1DDCD01M-EN_C / IFU 20190325-06-EN), DigniCap Delta Scalp Cooling Wrap (LAB 20190221-05-EN), DigniCap Delta Small Cooling Wrap (LAB 20200616-01-EN, Quick Reference Guide DigniCap Delta (IFU-20190327-02-EN), The DigniCap Scalp Cooling System Training Guide- Global (TR-20200104-05-EN), The DigniCap Scalp Cooling System Training Guide TR-2019-0801-05-US, DigniCap Delta Procedural Expectations- Global (TR-20191028-03-EN), DigniCap Delta Procedural Expectations TR- 20190721-02-US, DigniCap Delta Small Wrap Protocol Global(TR-20200728-02-EN), DigniCap Delta Small Wrap Protocol TR-20200714-01-US, DigniCap Delta Training Tips Global (TR-20200420-04-EN), DigniCap Delta Training Tips TR-20191202-05-US,

    FDA Enforcement
    Class II ·Terminated·Dignitana, Inc.·March 30, 2022