BEUDAMED
    18 results · 10ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii × Status: Ongoing × Clear all

    ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·October 2, 2024

    ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: 11711779, with software

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·October 2, 2024

    ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software.

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·October 2, 2024

    BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, Catalog # 10013902 BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite" VALVES, Catalog # 20062E; BD SECONDARY SET VENTED NONVENTED 20 DROP W/ 2 HANGERS, Catalog # 70000N-07; BD MaxGuardTM tri-fuse extension set, Catalog # ME1224; BD 20-IN EXTENSION SET W/ 0.2 MICRON FILTER ONE SmartSiteTM VALVE AND TexiumTM, Catalog # 20350ET; BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TexiumTM AND HANGER LOW SORBING, Catalog # 70001B-07T.

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Company·November 29, 2023

    Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2

    FDA Enforcement
    Class II ·Ongoing·Getinge Usa Sales Inc·October 11, 2023

    MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2) C-SECTION OR 30 CDS, REF CDS820075W; 3) C-SECTION, REF CDS980774M; 4) C-SECTION KIT, REF CDS981322AB; 5) C-SECTION KIT, REF CDS981322AC; 6) C-SECTION COMBINED CDS, REF CDS982398I; 7) C-SECTION PROCEDURE, REF CDS983450L; 8) C-SECTION-LF, REF CDS983869J; 9) C-SECTION, REF CDS984261J; 10) C-SECTION CDS-LF, REF CDS984516L; 11) C-SECTION CDS-LF, REF CDS984516M; 12) C-SECTION, REF CDS984902K; 13) C-SECTION, REF CDS984902L; 14) C-SECTION CDS, REF CDS985282F; 15) C-SECTION CDS, REF CDS985326G; 16) C SECTION, REF CDS985505G; 17) C-SECTION, REF CDSCCR611Q; 18) C-SEC GERBERUNI PK RFID-LF, REF DYNJ0100978K; 19) C-SECTION PACK-LF, REF DYNJ0101147G; 20) BR C-SECTION-LF, REF DYNJ0101562I; 21) BR C-SEC RFID-LF, REF DYNJ0101562K; 22) LUD C-SEC RFID-LF, REF DYNJ0101616L; 23) C-SECTION PACK-LF, REF DYNJ0173422AF; 24) C-SECTION PACK-LF, REF DYNJ0173422AG; 25) C-SECTION PACK-LF, REF DYNJ0190625Q; 26) C-SECTION PACK, REF DYNJ02577D; 27) SUT C-SECTION PACK, REF DYNJ02748F; 28) C-SECTION PACK-LF, REF DYNJ0282506N; 29) C-BIRTH PACK-LF, REF DYNJ0366291O; 30) C SECTION PACK-LF, REF DYNJ0378325M; 31) C SECTION PACK-LF, REF DYNJ0378325N; 32) C SECTION PACK-LF, REF DYNJ0451410O; 33) C-SECTION PACK-LF, REF DYNJ0536924T; 34) C-SECTION PACK-LF, REF DYNJ0536924U; 35) C-SECTION PACK-LF, REF DYNJ0551169V; 36) C-SECTION PACK-LF, REF DYNJ0551409O; 37) LAKELAND C-SECTION PACK-LF, REF DYNJ0619806K; 38) LKLND C-SEC PK RFID-LF, REF DYNJ0619806O; 39) C-SECTION PACK-LF, REF DYNJ0778455D; 40) C-SECTION PACK-LF, REF DYNJ0778455F; 41) C-SECTION PACK-LF, REF DYNJ0778455G; 42) C-SECTION PACK-LF, REF DYNJ07836Q; 43) C-SECTION PACK-LF, REF DYNJ0842739L; 44) C-SECTION PACK-LF, REF DYNJ0842739M; 45) C SECTION PACK-LF, REF DYNJ0854363I; 46) C SECTION PACK-LF, REF DYNJ0854363J; 47) C-SECTION PACK-LF, REF DYNJ0868053S; 48) C-SECTION TRAY-LF, REF DYNJ09174O; 49) C-SECTION TRAY, REF DYNJ16026G; 50) C-SECTION TRAY, REF DYNJ16026I; 51) C-SECTION PACK, REF DYNJ16614B; 52) C-SECTION PACK, REF DYNJ19417P; 53) C-SECTION PACK, REF DYNJ19417Q; 54) C-SECTION PACK, REF DYNJ19417R; 55) C-SECTION PACK-LF, REF DYNJ21569I; 56) C-SECTION PACK, REF DYNJ23432I; 57) C-SECTION LF-OR, REF DYNJ24232I; 58) C-SECTION LF-OR, REF DYNJ24232J; 59) SVMMC C-SECTION PACK, REF DYNJ24632K; 60) ST. CHARLES C-SECTION PACK, REF DYNJ24710I; 61) C-SECTION PACK, REF DYNJ25939N; 62) C-SECTION PACK, REF DYNJ26693M; 63) C-SECTION PACK, REF DYNJ30064O; 64) C-SECTION PACK, REF DYNJ30064P; 65) C-SECTION PACK, REF DYNJ32229M; 66) C-SECTION PACK, REF DYNJ32229N; 67) C-SECTION PACK, REF DYNJ32229O; 68) CUH C-SECTION PACK-LF, REF DYNJ32253G; 69) C-SECTION PACK, REF DYNJ32632F; 70) C-SECTION PACK-LF, REF DYNJ33059B; 71) C SECTION, REF DYNJ37535C; 72) C-SECTION PACK-LF, REF DYNJ37606J; 73) C-SECTION PACK SC-LF, REF DYNJ38063D; 74) C-SECTION PACK, REF DYNJ38229C; 75) C-SECTION PACK SC-LF, REF DYNJ38700G; 76) C-SECTION PACK-LF, REF DYNJ38845D; 77) C SECTION PACK, REF DYNJ43024D; 78) C SECTION PACK, REF DYNJ43024G; 79) C-SECTION PACK-CC, REF DYNJ43146F; 80) C-SECTION PACK, REF DYNJ44679L; 81) C-SECTION PACK, REF DYNJ44773S; 82) C-SECTION PACK, REF DYNJ44773T; 83) C-SECTION PACK, REF DYNJ44773U; 84) NMH C-SECTION PACK, REF DYNJ44773V; 85) C-SECTION PACK, REF DYNJ44861K; 86) C-SECTION TRAY, REF DYNJ46470F; 87) C-SECTION DELIVERY PACK-LF, REF DYNJ47808D; 88) C-SECTION DELIVERY PACK-LF, REF DYNJ47808F; 89) C SECTION PACK, REF DYNJ48087F; 90) WMC C-SECTION PACK-LF, REF DYNJ50655I; 91) C-SECTION I, REF DYNJ51354B; 92) C SECTION PACK, REF DYNJ51872D; 93) C SECTION PACK-LF, REF DYNJ52387M; 94) C SECT PK RFID-LF, REF DYNJ52387N; 95) C-SECTION PACK, REF DYNJ53528C; 96) C SECTION, REF DYNJ53654F; 97) C SECTION, REF DYNJ53654G; 98) C SECTION PACK, REF DYNJ54148D; 99) C SECTION PACK-LF, REF DYNJ54374J; 100) CMH C SECTION PACK-LF, REF DYNJ54374L; 101) MAG C-SECTION PREP

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·December 11, 2024

    Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed Male Luer With Priming Cap, REF: 10321213T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium Closed Male Luer With Priming Cap, REF: 22000-B007T; Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, REF: 22600-0007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22602-B007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22602-B007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22603-B007T; Bonded Texium Closed Male Luer with priming cap Back Check Valve 2 SmartSite Y-Sites, REF: 24010-0007T; SmartSite Bag Access Non-Vented 0.2 MicronFilter Bonded Texium Closed Low Sorbing Tubing (PE Lined) Male Luer with priming cap SmartSite Y-site, REF: 24301-0007T; SmartSite Bag Access Non-Vented Low Sorbing Texium Back Check Valve 2 SmartSite Y-Sites, REF: 24601-B007T. BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TEXIUMTM AND HANGER LOW SORBING, REF: 70001B-07T; BD 20-IN EXTENSION SET W/0.2 MICRON FILTER ONE SmartSite VALVE AND Texium, REF: 20350ET; BD Secondary Set 20 Drop Vented Non Vented With Texium & Hanger, REF: 40000-07T; BD 20 DROP SECONDARY SET SmartSite VALVE BAG ACCESS W/TEXIUM CLOSED MALE LUER HANGER, REF: 10013364T; BD 32-IN GRAV SET MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, REF: 4030B-07T; BD Texium Smartsite MICROBORE EXTENSION SET 60 IN, REF: 22005E-07T

    FDA Enforcement
    Class II ·Ongoing·BD SWITZERLAND SARL·June 18, 2025

    Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 3) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G; 4) ROBOTIC-LF, Model Number: CDS984543D; 5) ROBOTIC-LF, Model Number: CDS984543F; 6) ROBOTIC-LF, Model Number: CDS984543G; 7) ROBOTIC-LF, Model Number: CDS984543I; 8) GYN CDS, Model Number: CDS984860F; 9) GYN LAP PELVI, Model Number: CDS985423G; 10) GYN KIT, Model Number: DYKM1657A; 11) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL100; 12) KIT ROBOTICS GYN, Model Number: DYKMBNDL109; 13) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116D; 14) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116F; 15) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119; 16) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119A; 17) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168; 18) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168A; 19) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184D; 20) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91; 21) KIT GYN ONCOLOGY, Model Number: DYKMBNDL92; 22) KIT GYN ONCOLOGY, Model Number: DYKMBNDL92A; 23) KIT GYN ABDOMINAL, Model Number: DYKMBNDL92C; 24) KIT GYN LAP, Model Number: DYKMBNDL94; 25) KIT GYN LAP, Model Number: DYKMBNDL94A; 26) KIT GYN LAP, Model Number: DYKMBNDL94C; 27) KIT GYN LAP, Model Number: DYKMBNDL94D; 28) GYN LAPAROSCOPY PACK-LF, Model Number: DYNJ0281948N; 29) PROSTATE ROBOTIC PACK, Model Number: DYNJ0347372F; 30) PROSTATE ROBOTIC PACK, Model Number: DYNJ0347372G; 31) PROSTATE ROBOTIC PACK, Model Number: DYNJ0347372I; 32) HEALTH ALL GYN LAP PACK-LF, Model Number: DYNJ28252G; 33) GYN OPERATIVE LAP PACK-LF, Model Number: DYNJ30005G; 34) OB PACK, Model Number: DYNJ32706B; 35) ROBOTIC UROLOGY-RF, Model Number: DYNJ38844N; 36) ENSEMBLE GYNE LAPAROTOMIE-LF, Model Number: DYNJ47550C; 37) GYN LAP PACK, Model Number: DYNJ47714A; 38) TASC GYN LAP, Model Number: DYNJ49191B; 39) ROBOTIC PACK, Model Number: DYNJ49705K; 40) GYN LAPAROSCOPY PACK, Model Number: DYNJ50348F; 41) NWH GYN LAPAROSCOPY, Model Number: DYNJ50439F; 42) FH LAPAROSCOPIC GYN PK-LF, Model Number: DYNJ51795F; 43) GYN LAPAROSCOPY PACK, Model Number: DYNJ52569B; 44) LAVH PACK, Model Number: DYNJ55862; 45) PK, GEN-LAPAROSCOPY, Model Number: DYNJ57607A; 46) GYN LAPAROSCOPY MRNGSD, Model Number: DYNJ58321A; 47) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079B; 48) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079C; 49) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079D; 50) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079F; 51) GYN DAVINCI PACK, Model Number: DYNJ64266; 52) DAVINCI PACK, Model Number: DYNJ66298D; 53) GYN LAPAROSCOPY, Model Number: DYNJ67269; 54) GENERAL GYN PACK, Model Number: DYNJ68710; 55) LAP GYN PACK, Model Number: DYNJ69419A; 56) LAP GYN PACK, Model Number: DYNJ69419D; 57) GYN LAPAROSCOPY, Model Number: DYNJ81492A; 58) PK, ROBOTIC GYN & GU-ROSE MEDI, Model Number: DYNJ81761A; 59) GYN PACK, Model Number: DYNJ83475A; 60) ROBOTIC XI PACK, Model Number: DYNJ84783; 61) GYN PACK, Model Number: DYNJ86195A; 62) GYN LAPAROSCOPY, Model Number: DYNJ900262A; 63) D&C HYSTEROSCOPY, Model Number: DYNJ901133A; 64) GYN LAPAROSCOPY, Model Number: DYNJ901559J; 65) GYN ENDOSCOPY-LF, Model Number: DYNJ901812J; 66) GYN LITHOTOMY-LF, Model Number: DYNJ902711M; 67) GENERAL ROBOTIC, Model Number: DYNJ905066B; 68) TRINITY C-SEC W/LINEN CDS, Model Number: DYNJ905269G; 69) KIT GYN LAPAROSCOPY RFD, Model Number: DYNJ906322D; 70) GYN LAP LH, Model Number: DYNJ906452C; 71) GYN LAP LH, Model Number: DYNJ906452D; 72) GYN LAP LH, Model Number: DYNJ906452F; 73) FLOYD LITH GYN, Model Number: DYNJ906926B; 74) GYN LAPAROSCOPY-MRMC, Model Number: DYNJ907753F; 75) GYN LAPAROSCOPY-SFMC, Model Number: DYNJ907771C; 76) LAP/GYN ROBOTICS, Model Number: DYNJ908887B; 77) LAP/GYN ROBOTICS, Model Number: DYNJ908887C;

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·February 25, 2026

    Seca 402/403 Baby Scale Cart, Ref # 4020000009/ REF # 4030000009

    FDA Enforcement
    Class II ·Ongoing·Seca·March 11, 2020

    OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024

    OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic Xray images and volumetric reconstructions during diagnostic, interventional, and surgical procedures.

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024

    OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024

    OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024

    OEC 9900 Systems with 9-inch Image Intensifier

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·August 9, 2023

    OEC Flexiview 8800 Systems with 9-inch Image Intensifier

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·August 9, 2023

    Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE INTENSIFIER, 9 INCH - used with OEC Flexiview 8800, OEC 9800, and OEC 9900 Systems

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·August 9, 2023

    OEC Elite Systems with 9-inch Image Intensifier

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·August 9, 2023

    OEC 9800 Systems with 9-inch Image Intensifier

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·August 9, 2023