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

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    Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54613

    FDA Recall
    Open, Classified ·Cook Biotech, Inc.·Product code FTM·August 7, 2024

    Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54612

    FDA Recall
    Open, Classified ·Cook Biotech, Inc.·Product code FTM·August 7, 2024

    Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54614

    FDA Recall
    Open, Classified ·Cook Biotech, Inc.·Product code FTM·August 7, 2024

    Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46374

    FDA Recall
    Open, Classified ·Cook Biotech, Inc.·Product code FTM·August 7, 2024

    Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46372

    FDA Recall
    Open, Classified ·Cook Biotech, Inc.·Product code FTM·August 7, 2024

    Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46373

    FDA Recall
    Open, Classified ·Cook Biotech, Inc.·Product code FTM·August 7, 2024

    Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S

    FDA Recall
    Open, Classified ·EMPATICA SRL Via Enrico Stendhal·Product code POS·July 13, 2023

    Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit

    FDA Recall
    Open, Classified ·ROi CPS LLC·Product code OEZ·September 21, 2023

    Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. regard Item Number: 880396007, NU01001G - Craniotomy ; 4. regard Item: 880387005, NU00991E - Ant/Cervical Spine ; and 5. regard Item Number: 800716005, NU00921E - ORMC Major Crani Pack.

    FDA Recall
    Open, Classified ·ROi CPS LLC·Product code OJG·March 22, 2023

    Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.

    FDA Recall
    Open, Classified ·ROi CPS LLC·Product code OHM·March 22, 2023

    regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.

    FDA Recall
    Open, Classified ·ROi CPS LLC·Product code MLS·December 26, 2024

    Regard, Item Number 830067009, custom cardiovascular procedure kit

    FDA Recall
    Open, Classified ·ROi CPS LLC·Product code OEZ·March 4, 2021

    Regard Kit containing the Microtek decanter

    FDA Recall
    Open, Classified ·ROi CPS LLC·Product code KPE·June 17, 2024

    regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009

    FDA Recall
    Open, Classified ·ROi CPS LLC·Product code OEQ·July 24, 2024

    Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.

    FDA Recall
    Open, Classified ·ROi CPS LLC·Product code MLS·March 22, 2023

    Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item Number: 800725004, GS00930D - OH Base Robot Pack ; 4. regard Item Number: 800725005, GS00930E - OH Base Robot Pack ; 5. regard Item Number: 800395003, GS01000C - Colon Lithotomy and 6. regard Item Number: 880391002, GS00995B - Basic Laparotomy.

    FDA Recall
    Open, Classified ·ROi CPS LLC·Product code LRO·March 22, 2023

    Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.

    FDA Recall
    Open, Classified ·ROi CPS LLC·Product code FDE·March 22, 2023

    Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.

    FDA Recall
    Open, Classified ·ROi CPS LLC·Product code OES·March 22, 2023

    Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D - Total Hip; 3. regard Item Number: 880427003, OR01034C - Total Knee; 4. regard Item Number: 880474001, OR01106A - Knee Arthroscopy; 5. regard Item Number: 800772006, OR00977F - OH Total Knee Pack ; 6. regard Item Number: 880403004, OR01009D - Extremity Pack; 7. regard Item Number: 880472001, OR01104A - Basic Pack ; 8. regard Item Number: 880470001, OR01102A - Total Knee ; 9. regard Item Number: 800755006, OR00960F - OH Hip Pack ; 10. regard Item Number: 880471001, OR01103A - Shoulder Arthroscopy ; 11. regard Item Number: 880480001, OR01112A - Hand and Foot ; and 12. regard Item Number: 880468001, OR01100A - Spine.

    FDA Recall
    Open, Classified ·ROi CPS LLC·Product code OJH·March 22, 2023

    Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.

    FDA Recall
    Open, Classified ·ROi CPS LLC·Product code OHD·March 22, 2023