BEUDAMED
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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012

    FDA Enforcement
    Class II ·Ongoing·Aomori Olympus Co., Ltd.·September 13, 2023

    Terumo Advanced Perfusion System 1 System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·July 25, 2012

    Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·July 25, 2012

    DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01

    FDA Enforcement
    Class II ·Ongoing·FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD·October 9, 2024

    Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap towelettes are used to clean the genital area for male and female patients

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·March 30, 2016

    Covidien Dover PRECSION PRM 18FR SIL FLY Item Code: PP18SD Castile soap towelettes are used to clean the genital area for male and female patients

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·March 30, 2016

    Covidien Dover PRECSION PRM 14FR SIL FLY Item Code: ¿ PP14SD ¿¿ Castile soap towelettes are used to clean the genital area for male and female patients

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·March 30, 2016

    Covidien Dover PREC PRM 14FR SILVER FLY TY Item Code: PP14XSD ¿ ¿¿ Castile soap towelettes are used to clean the genital area for male and female patients

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·March 30, 2016

    Covidien Dover PREC PRM 18FR SILVER FLY TY Item Code: PP18XSD Castile soap towelettes are used to clean the genital area for male and female patients

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·March 30, 2016

    Covidien Dover PREC PRM 16FR SILVER FLY TY Item Code: PP16XSD Castile soap towelettes are used to clean the genital area for male and female patients

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·March 30, 2016

    Covidien Dover P400 PREM U/M 16FR SLVR FLY Item Code: P4P16XSD Castile soap towelettes are used to clean the genital area for male and female patients

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·March 30, 2016

    Covidien Dover 400 PREM U/M 18FR SLVR FLY Item Code: ¿¿¿ P4P18XSD Castile soap towelettes are used to clean the genital area for male and female patients

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·March 30, 2016

    Covidien Dover PREM U/M 14FR SIL FLY Item Code: P4P14SD P400 Castile soap towelettes are used to clean the genital area for male and female patients

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·March 30, 2016

    Covidien Dover P400 PREM U/M 16FR SIL FLY Item Code: P4P16SD Castile soap towelettes are used to clean the genital area for male and female patients

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·March 30, 2016

    Covidien Dover PREM U/M 14FR SLVR FLY Item Code: P4P14XSD P400 Castile soap towelettes are used to clean the genital area for male and female patients

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·March 30, 2016

    Covidien Dover P400 PREM U/M 18FR SIL FLY Item Code: P4P18SD Castile soap towelettes are used to clean the genital area for male and female patients

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·March 30, 2016

    Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile, Rx. The firm name on the label is Rhondium Ltd., Katikati, New Zealand.

    FDA Enforcement
    Class II ·Completed·RHONDIUM LIMITED·December 25, 2019

    FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defiance Industries Automated Field Steam Sterilizer Model P2131 is designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used in healthcare facilities. The P2131 sterilizer is a transportable device designed for use in a variety of austere environments.

    FDA Enforcement
    Class II ·Terminated·Fort Defiance Industries, LLC·July 18, 2018

    GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare GmbH·December 24, 2025

    Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (Model BB10Q85R); 2. CUSTOM PACK BB11C01R MIDI DEEP (Model BB11C01R); 3. CUSTOM PACK BB7H95R22 HYP MAIN (Model B7H95R22); 4. CUSTOM PACK BB7H95R25 HYP MAIN (Model BB7H95R25); 5. CUSTOM PACK BB7H99R22 NEONAT (Model BB7H99R22); 6. CUSTOM PACK BB7P46R4 316-14 (Model BB7P46R4); 7. CUSTOM PACK BB7P48R4 14-38 (Model BB7P48R4); 8. CUSTOM PACK BB7W03R8 CCSM NEON (Model BB7W03R8); 9. CUSTOM PACK BB7W80R7 BASC PEDS (Model BB7W80R7); 10. CUSTOM PACK BB8B09R7 INFANT (Model BB8B09R7); 11. CUSTOM PACK BB8B09R8 INFANT (Model BB8B09R8); 12. CUSTOM PACK BB8D40R3 P3/16X1/4 (Model BB8D40R3); 13. CUSTOM PACK BB8Q16R PED ART (Model BB8Q16R); 14. CUSTOM PACK BB8V01R8 FVDL COLM (Model BB8V01R8); 15. CUSTOM PACK HY2V10R33 ADULT (Model HY2V10R33); 16. CUSTOM PACK HY3Z71R17 PRIMARY (Model HY3Z71R17); 17. CUSTOM PACK HY3Z71R18 PRIMARY (Model HY3Z71R18); 18. CUSTOM PACK HY4V00R24 ADULT (Model HY4V00R24); 19. CUSTOM PACK HY6X29R12 CON-SUPP (Model HY6X29R12); 20. CUSTOM PACK HY8L14R7 HYBRID (Model HY8L14R7); 21. CUSTOM PACK HY8P36R6 CPS (Model HY8P36R6); 22. CUSTOM PACK HY8V01R6 FVDL COLM (Model HY8V01R6); 23. CUSTOM PACK HY9D36R1 HL PUMP P (Model HY9D36R1); 24. CUSTOM PACK HY9L07R4 ADLT FUS (Model HY9L07R4); 25. CUSTOM PACK HY9L80R4 SADT FUS (Model HY9L80R4); 26. CUSTOM PACK HY9M47R6 ADLT MAIN (Model HY9M47R6); 27. CUSTOM PACK HY9N38R4 VGH FUS (Model HY9N38R4); 28. CUSTOM PACK HY9R26R12 CENT (Model HY9R26R12); 29. PERFUSION M337112Q 1/B (Model M337112Q); 30. PERFUSION M344130B 1/B (Model M344130B); 31. PERFUSION M392419C 1/B (Model M392419C); 32. PERFUSION M394213B 1/B (Model M394213B); 33. PERFUSION M394213C 1/B (Model M394213C); 34. PERFUSION M490124D 1/B (Model M490124D); 35. PERFUSION M491335A 1/B (Model M491335A); 36. PERFUSION M499709E 1/B (Model M499709E); 37. PERFUSION M960164F 1/B (Model M960164F); 38. PERFUSION M960165E 1/B (Model M960165E); 39. PERFUSION M960169E 1/B (Model M960169E); 40. PERFUSION M960462C 1/B (Model M960462C); 41. PERFUSION M960462D 1/B (Model M960462D); 42. PERFUSION M960463D 1/B (Model M960463D); 43. PERFUSION M960466D 1/B (Model M960466D); 44. CUSTOM PACK TL4K33R3 FCI ADULT (Model TL4K33R3); 45. CUSTOM PACK TL4K95R12 PERFNPLEG (Model TL4K95R12); 46. CUSTOM PACK TL6C91R5 SELLKE PK (Model TL6C91R5); 47. CUSTOM PACK TL6G48R9 ST PAULS (Model TL6G48R9); 48. CUSTOM PACK TL7X09R3 FCVC ADLT (Model TL7X09R3);

    FDA Enforcement
    Class II ·Ongoing·Medtronic Perfusion Systems·January 19, 2022