BEUDAMED
    16 results · 12ms · Sources: EU EUDAMED, US FDA

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    Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code HFX·May 23, 2023

    Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code HFX·March 2, 2023

    (1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and Insert, Reorder #210CR, Sterile; (3) Centurion CirClamp with 1.13cm Bell and Insert, Reorder #230CR, Sterile; (4) Centurion CirClamp with 1.45cm Bell and Insert, Reorder #245CR, Sterile; (5) Centurion CirClamp with 1.1cm Bell, Reorder #310CR, Sterile; (6) Centurion CirClamp with 1.1cm Bell Reprocessed, Reorder #310CRK, Sterile; (7) Centurion CirClamp with 1.3cm Bell, Reorder #330CR, Sterile; (8) Centurion CirClamp with 1.3cm Bell Reprocessed, Reorder #330CRK, Sterile; (9) Centurion CirClamp with 1.6cm Bell, Reorder #345CR, Sterile; (10) Centurion CirClamp with 1.45cm Bell, Reorder #3145CR, Sterile; (11) Centurion CirClamp with 1.1cm Bell & Insert Reprocessed, Reorder #CR210K, Sterile; (12) Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile; (13) Centurion CirClamp with 1.145cm Bell & Insert Reprocessed, Reorder #CR245K, Sterile; (14) Centurion CirClamp with 1.6cm Bell Reprocessed, Reorder #CR345K, Sterile; and (15) Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder #CR3145K.

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code HFX·September 3, 2024

    Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10

    FDA Recall
    Open, Classified ·Diversatek Healthcare·Product code FFX·June 4, 2025

    ZVU Functional GI Software, REF: ZVU-3

    FDA Recall
    Open, Classified ·Diversatek Healthcare·Product code FFX·July 25, 2023

    Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210

    FDA Recall
    Open, Classified ·FX SHOULDER·Product code PHX·August 8, 2023

    Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Model/Catalog Number: 1023770 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 12 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A

    FDA Recall
    Open, Classified ·HF Acquisition Co LLC·Product code FRC·April 13, 2026

    Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580

    FDA Recall
    Open, Classified ·HF Acquisition Co LLC·Product code FRC·December 11, 2024

    Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Model/Catalog Number: 1023780 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 52 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A

    FDA Recall
    Open, Classified ·HF Acquisition Co LLC·Product code FRC·April 13, 2026

    RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component

    FDA Recall
    Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024

    RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component

    FDA Recall
    Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024

    Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adaption Kit, REF: L-621100; Ratchet Lock Body, REF: L-692020

    FDA Recall
    Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISH·May 12, 2023

    Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

    FDA Recall
    Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code IQK·August 20, 2024

    RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component

    FDA Recall
    Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024

    RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component

    FDA Recall
    Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024

    Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002

    FDA Recall
    Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·December 26, 2023