19 results
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20ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-2020/60
FDA Enforcement
Class II
·Ongoing·Linkbio Corp.·May 10, 2023
LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40
FDA Enforcement
Class II
·Ongoing·Linkbio Corp.·May 10, 2023
LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2020/52
FDA Enforcement
Class II
·Ongoing·Linkbio Corp.·May 10, 2023
1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humification of ventilator-dependent and non-ventilator dependent patients in critical care, home care and anesthesia.
FDA Enforcement
Class II
·Terminated·AB ULAX·October 14, 2020
LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2020/46
FDA Enforcement
Class II
·Ongoing·Linkbio Corp.·May 10, 2023
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020
Kit BD Max Enteric Parasite Panel EU; Catalog # 442960
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
Sterile Custom Packs to be used in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Contract Systems·June 10, 2020
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·May 20, 2026
LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000, BT2101, BT2103, BT2105, BT2106, BT2210, BT2201, BT2203, BT2205, BR2200, BP2200, BI2200, BR2000, BP2000, BI2999, BR2103, BP2103, BI2103, BR2101, BP2101, BI2101, BI2001, BDL2420
FDA Enforcement
Class II
·Terminated·Lymol Medical Corporation·October 6, 2021
HEMO-7 Hemospray Endoscopic Hemostat
FDA Enforcement
Class II
·Terminated·Wilson-Cook Medical Inc.·April 29, 2020
HEMO-10 Hemospray Endoscopic Hemostat
FDA Enforcement
Class II
·Terminated·Wilson-Cook Medical Inc.·April 29, 2020
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
FDA Enforcement
Class II
·Terminated·Avid Medical, Inc.·March 25, 2020
CardioTek EP-TRACER Software V2.x.
FDA Enforcement
Class II
·Completed·CardioTek BV·June 29, 2022
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
FDA Enforcement
Class II
·Terminated·Avid Medical, Inc.·March 25, 2020
Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral agents
FDA Enforcement
Class II
·Terminated·Hardy Diagnostics·December 30, 2020
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 26, 2014
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023