BEUDAMED
    19 results · 14ms · Sources: EU EUDAMED, US FDA

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    Penner Pacific Bathing Spa, Model Numbers 360020-1EP

    FDA Recall
    Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

    Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model Number: VASCSLPOFF1; 3) EP MANIFOLD KIT, Model Number: VASC1018A

    FDA Recall
    Open, Classified ·Product code DXT·February 25, 2026

    Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2) MERCY COMBINED PACK-LF, Pack Number DYNJ0233004D ; 3) E P DRAPE PACK-LF , Pack Number DYNJ0373061J ; 4) PACEMAKER DRAPE PACK-LF , Pack Number DYNJ0406118K ; 5) FEMORAL ANGIOGRAPHY PACK, Pack Number DYNJ0618509F ; 6) EP DRAPE PACK-LF, Pack Number DYNJ22911I ; 7) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ36314J ; 8) SPLIT DRAPE , Pack Number DYNJ37265F ; 9) 4 DRAPE PROCEDURE PACK, Pack Number DYNJ39689D ; 10) DR MOTT DRAPE PACK, Pack Number DYNJ42065B ; 11) PK, EP LAB, Pack Number DYNJ43815C ; 12) MAYO STAND PACK , Pack Number DYNJ50738; 13) DAA BI-LAT, Pack Number DYNJ903538C; 14) PACEMAKER , Pack Number DYNJ903545C; 15) CSTM NEONATAL FEM DRAPE PK, Pack Number DYNJCD0114

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code KKX·April 8, 2024

    VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc·Product code CEP·March 25, 2022

    VIDAS LH, REF 30406-01

    FDA Recall
    Open, Classified ·bioMerieux, Inc.·Product code CEP·September 22, 2021

    Recreo Hair Growth Laser Comb

    FDA Recall
    Open, Classified ·OMM Imports, Inc. dba Zero Gravity·Product code OAP·September 1, 2022

    Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Tubing sets with push-on connector on one end (to attach to the Fluid Selector Valve) and a spike or other appropriate connector on the opposite end to attach the source container.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code NEP·April 22, 2026

    Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM). 2. Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGE (20MMX40MM). Model/Catalog Number: IVS-RBT-001. i.v.STATION is an automation device used for preparation and compounding of IV medications, which also applies labels to compounded preparations for identification and traceability.

    FDA Recall
    Open, Classified ·Omnicell, Inc.·Product code NEP·March 25, 2026

    Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373

    FDA Recall
    Open, Classified ·OmniCell, Inc.·Product code NEP·March 27, 2023

    VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code CEP·November 9, 2022

    OEC Elite Systems with 9-inch Image Intensifier

    FDA Recall
    Open, Classified ·GE OEC Medical Systems, Inc·Product code OWB·May 15, 2023

    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 Recall
    Open, Classified ·GE OEC Medical Systems, Inc·Product code OXO·November 21, 2024

    OEC Flexiview 8800 Systems with 9-inch Image Intensifier

    FDA Recall
    Open, Classified ·GE OEC Medical Systems, Inc·Product code OXO·May 15, 2023

    OEC 9900 Systems with 9-inch Image Intensifier

    FDA Recall
    Open, Classified ·GE OEC Medical Systems, Inc·Product code OXO·May 15, 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 Recall
    Open, Classified ·GE OEC Medical Systems, Inc·Product code OXO·May 15, 2023

    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 Recall
    Open, Classified ·GE OEC Medical Systems, Inc·Product code OXO·November 21, 2024

    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 Recall
    Open, Classified ·GE OEC Medical Systems, Inc·Product code OXO·November 21, 2024

    OEC 9800 Systems with 9-inch Image Intensifier

    FDA Recall
    Open, Classified ·GE OEC Medical Systems, Inc·Product code OWB·May 15, 2023

    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 Recall
    Open, Classified ·GE OEC Medical Systems, Inc·Product code OXO·November 21, 2024