BEUDAMED
    12 results · 13ms · Sources: EU EUDAMED, US FDA

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    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

    OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem

    FDA Enforcement
    Class II ·Ongoing·Oxoid Australia Pty Limited·April 8, 2026

    SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

    FDA Enforcement
    Class I ·Ongoing·Glycar SA Pty., Ltd.·December 3, 2025

    Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G

    FDA Enforcement
    Class II ·Ongoing·Ellex Medical Pty Ltd.·July 5, 2023

    Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and analysis. The Seer Home System includes the Sight Monitoring Hub, the Sense wearable, Monitoring Portal and associated accessory components (Disposable EEG Wires, WaterTabs, WaterTabs Application Kit, and Take-home Kit).

    FDA Enforcement
    Class II ·Ongoing·SEER MEDICAL PTY LTD·September 25, 2024

    SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

    FDA Enforcement
    Class I ·Ongoing·Glycar SA Pty., Ltd.·December 3, 2025

    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BASIC CL PACK-LF DYNJ87052 BASIC PACK DYNJ83976 BASIC SET UP PACK DYNJ80700 CORONARY ANGIOGRAPHY PACK (N) DYNJ42136B CSTM ANGIO KIT - S VASC1109 CV PACK DYNJ46301C DR F PACK DYNJ41253B ENSEMBLE HEMORROIDES DYNJ56311A G TAVR PACK DYNJ61006 IR MINOR PACK DYNJ44139C MAJOR PLUS PACK DYNJ905160N MAXIMUM BARRIER BUNDLE PACK DYNJ35216C PCI PACK TBRHSC-LF DYNJ41941D PERC PACK-LF DYNJ0774759P PERIPHERAL ANGIOGRAPHY PK DYNJ42094B PROCEDURE PACK DYNJ55063B PTCA PACK DYNJ55359B ROBOTIC PACK DYNJ908706C SPECIAL PROCEDURES TRAY DYNJ41174A SYRINGE WIRE KIT SANFORD SAMPC0644 WPH EP PACK DYNJ62745 X-RAY PACK DYNJ44295G

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·April 29, 2026

    HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.

    FDA Enforcement
    Class II ·Ongoing·Leica Biosystems Melbourne Pty Ltd·May 7, 2025

    Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/Pack numbers: Ports Cath Pack (1794)/AMS6569, Minor Procedure Pack (20527)/AMS6570B, Breast Biopsy Pack (24771)/AMS6572A, Bone Marrow Pack (11862)/AMS6573, Ultrasound Biopsy Pack -Rx/AMS6828, Ultrasound Biopsy Pack -Rx/AMS6828A, C Access Tray/AMS9954, C Access Tray/AMS9954A, Access Tray A/AMS10234, Access Tray A/AMS10234A, C-Access Tray Chicago/AMS10236, C-Access Tray Chicago/AMS10236A, Access Tray/AMS10238, Access Tray/AMS10238A, Access Tray/AMS10238B, Gray Pack/AMS10247, Gray Pack/AMS10247A, C-Access Tray/AMS10249, C-Access Tray/AMS10249A, C Access Tray/AMS10255, C Access Tray/AMS10255A, Jacksonville Tray/AMS10256, Jacksonville Tray/AMS10256A, Jacksonville Tray/AMS10256B, NVS Access Tray/AMS10257, AZ Access Tray/AMS10271, AZ Access Tray/AMS10271A, Fistulagram/ C-Access Pack/AMS10280, Fistulagram/ C-Access Pack/AMS10280A, Ultrasound Tray w/PDI/AMS10710A, Procedure Tray/AMS10897A, Universal Block Tray-RX/AMS12381, Ultrasound Injection-RX/AMS12382, Pellet Insertion Tray/AMS12735, PICC Insertion Tray - RX/AMS-7192CS-8, Breast Biopsy Tray/DDS1010G, Single Shot Epidural Tray-Rx/DDS1149, PICC Insertion Tray-RX/VYMAXBASIC

    FDA Enforcement
    Class II ·Ongoing·Windstone Medical Packaging, Inc.·May 25, 2022

    Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A Nasal Endoscopy Pack AMS10710A Ultrasound Tray w/PDI AMS11941 Total Knee Pack AMS12138B Eye Pack AMS12278B Body Pack AMS12341A Hassan Pack AMS12341B Hassan Pack AMS12343A Meldrum Pack AMS12359B Neuro Pack AMS12520 Total Hip Pack AMS12608 Extremity Pack AMS12610 Shoulder Pack AMS12636 Dr. Thompson Pack AMS12689A Custom Pack AMS12753 Breast Pack AMS12754 Abdominoplasty Pack AMS12769 Minor Pack AMS12926 Shoulder Pack AMS12927 Retina Pack AMS13428 Hand Pack AMS2120D Plastics Tray AMS2890(B Basic Biopsy Tray AMS3824(A Myelogram Tray - RX AMS4022F Lami Pack AMS4371C Lasik Eye Pack AMS4372 Plastic Eye Pack AMS4599(C Spine Pack AMS4670B Upper Extremity Pack AMS4766C Shoulder Arthroscopy Pack AMS4952A Vitrectomy Pack - RX AMS5697A EVLT Pack AMS5819B Ortho Major Pack AMS5887A CARS Pack AMS6112A Minor Extremity Pack AMS6112B Minor Extremity Pack AMS6160C Hip Pack AMS6277A Procurement Bundle - Pack A/B/C AMS6728A Breast Pack AMS7463B Retrieval Pack AMS7971 TVOR Pack AMS8094 Plastics Eye Pack AMS8664B Spinal Pack AMS8989 Hysteroscopy Pack AMS9118 Retrieval Pack AMS9197 Arthroscopy Pack AMS9435 Foot Pack AMS9487A Toy Hip Pack AMS9487B Total Hip Pack CMP1018G Cataract Kit - Dr. Wright PSS1838B Medical Imaging Kit VPP1020A Custom Dental Pack VPP1023B OR Implant Bundle Pack WAL1207C Minor Pack

    FDA Enforcement
    Class II ·Ongoing·Windstone Medical Packaging, Inc.·January 11, 2023

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

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

    Medline Convenience kits, labeled as: 1) SINGLE SHOT EPIDURAL PACK-LF, Pack Number DYNJ0708470K ; 2) EPIDURAL CSTM PACK-LF , Pack Number DYNJ0844004; 3) CUSTOM EPIDURAL PACK-LF , Pack Number DYNJ0934752F ; 4) EPIDURAL PACK-LF, Pack Number DYNJ0957053D ; 5) EPIDURAL PACK-LF, Pack Number DYNJ0957053DH; 6) SINGLE SHOT TRAY, Pack Number DYNJ32736; 7) CONTINUOUS EPIDURAL TRAY-LF , Pack Number DYNJ34352A ; 8) SINGLE SHOT EPIDURAL-LF , Pack Number DYNJ36046A ; 9) PHOENIXVILLE EPIDURAL TRAY, Pack Number DYNJ40991A ; 10) UNIVERSAL SCOPE PACK, Pack Number DYNJ45052A ; 11) SPINAL PACK , Pack Number DYNJ48916B ; 12) PUH SPINAL BLOCK TRAY , Pack Number DYNJ49205B ; 13) EPIDURAL PACK , Pack Number DYNJ50772A ; 14) TRANSFORAMINAL PACK , Pack Number DYNJC3420D ; 15) EPIDURAL PREP TRAY-LF , Pack Number DYNJRA0135B; 16) SUPPORT TRAY-LF, Pack Number DYNJRA0198; 17) SPINAL TRAY W/GERTIE MARX NDL , Pack Number DYNJRA0245 ; 18) EPIDURAL TRAY , Pack Number DYNJRA0260 ; 19) SPINAL EPIDURAL (TUOHY) PF, Pack Number DYNJRA0270B; 20) EPIDURAL TRAY-LF, Pack Number DYNJRA0275A; 21) SPINAL BLOCK TRAY- LF , Pack Number DYNJRA0413B; 22) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number DYNJRA0506A; 23) EPIDURAL TRAY , Pack Number DYNJRA0508 ; 24) SPINAL TRAY W/GERTIE MARX NDL , Pack Number DYNJRA0555 ; 25) COMBINED SPINAL/EPIDURAL PACK , Pack Number DYNJRA0635 ; 26) SPINAL BLOCK, 25G QUINCKE , Pack Number DYNJRA0766 ; 27) TRANSFORAMINAL 22X5PF , Pack Number DYNJRA0777F; 28) TRANSFORMINAL TRAY, Pack Number DYNJRA0822A; 29) SPINAL TRAY, Pack Number DYNJRA0836A; 30) SPINAL TRAY , Pack Number DYNJRA0978A; 31) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA0988 ; 32) TRAY, SPINAL, WHIT 24GX4, Pack Number DYNJRA1034 ; 33) TRANSFORAMINAL TRAY , Pack Number DYNJRA1730A; 34) SPINAL BLOCK 25G WHTCRE 5S BU , Pack Number DYNJRA9028 ; 35) SPINAL BLOCK 25G WHTCRE 5S BU , Pack Number DYNJRA9028H; 36) TRAY, SPINAL PENCIL POINT 25G , Pack Number DYNJRA9030 ; 37) SPINAL BLOCK TRAY, 22G QUINCKE, Pack Number DYNJRA9036 ; 38) SPINAL BLOCK TRAY, 22G QUINCKE, Pack Number DYNJRA9036H; 39) SPINAL BLOCK, 25G QUINCKE , Pack Number DYNJRA9037 ; 40) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0012 ; 41) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0024D; 42) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0055A; 43) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0058D; 44) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0078C; 45) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0082D; 46) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0111C; 47) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0133 ; 48) COMPLETE SINGLE SHOT TRAY , Pack Number PAIN0136A; 49) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0146C; 50) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0157G; 51) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0171C; 52) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0191I; 53) NORTON SINGLE SHOT EPIDURAL , Pack Number PAIN0215A; 54) EPIDURAL TRAY , Pack Number PAIN0225 ; 55) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0242B; 56) SINGLE SHOT EPIDURAL-LF , Pack Number PAIN0250A; 57) SINGLE SHOT EPIDURAL-LF , Pack Number PAIN0256B; 58) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0261A; 59) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0262A; 60) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0265C; 61) EPI TRAY, SINGLE , 20G-LF , Pack Number PAIN0274A; 62) EPI TRAY CONTI 17G TUOHY, Pack Number PAIN0275 ; 63) EPIDURAL TRAY-LF, Pack Number PAIN0279C; 64) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0280C; 65) SINGLE DOSE EPI-LF, Pack Number PAIN0300B; 66) SINGLE DOSE EPIDURAL TRAY-LF, Pack Number PAIN0317A; 67) SINGLE SHOT EPIDURAL TRAY-LF, Pack Number PAIN0334A; 68) EPIDURAL TRAY-LF, Pack Number PAIN0349B; 69) SINGLE DOSE EPIDURAL TRAY-LF, Pack Number PAIN0357B; 70) SHOT EPIDURAL TRAY-LF , Pack Number PAIN0362 ; 71) SINGLE SHOT EPIDURAL TRAY , Pack Number PAIN0386B; 72) CONTINUOUS EPIDURAL TRAY, Pack Number PAIN0390 ; 73) SINGLE SHOT EPIDURAL T

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024