10,000 results
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16ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840
FDA Enforcement
Class II
·Ongoing·Maquet Medical Systems USA·June 7, 2023
Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L RED Model/Catalog Number: 91878 Product Description: NON-Sterile syringes without needles for single use Component: No
FDA Enforcement
Class II
·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024
TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecological and gynecological cytology and autopsy activities.
FDA Enforcement
Class II
·Ongoing·Technidata S.A.·May 17, 2023
HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946
FDA Enforcement
Class II
·Ongoing·Stradis Medical, LLC dba Stradis Healthcare·December 21, 2022
Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144
FDA Enforcement
Class II
·Ongoing·PHILIPS HEADQUARTERS CAMBRIDGE·May 31, 2023
HAMILTON-C6, REF: 160021
FDA Enforcement
Class II
·Ongoing·Hamilton Medical AG·May 3, 2023
Brand Name: MEDLINE Product Name: SYR 20ML L/L GREEN Model/Catalog Number: 91836 Product Description: NON-Sterile syringes without needles for single use Component: No
FDA Enforcement
Class II
·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024
DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.08
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813
FDA Enforcement
Class II
·Ongoing·Philips North America·May 24, 2023
BD Insulin Syringes with the BD Micro-Fine IV Needle 1 ml, 12. 7mm, 28G Two Unit Scale- Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329424
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Company·March 22, 2023
Brand Name: GMAX Product Name: SYR 10ML/LL syringe Model/Catalog Number: TS2210L-M Product Description: NON-Sterile syringes without needles for single use Component: No
FDA Enforcement
Class II
·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024
Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)
FDA Enforcement
Class II
·Ongoing·PHILIPS HEADQUARTERS CAMBRIDGE·May 31, 2023
HENRY SCHEIN, CATH PACK Item No.570-2789
FDA Enforcement
Class II
·Ongoing·Stradis Medical, LLC dba Stradis Healthcare·December 21, 2022
Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.
FDA Enforcement
Class II
·Ongoing·ROi CPS LLC·May 3, 2023
Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage device. Part Number: 82-6607
FDA Enforcement
Class II
·Ongoing·Integra LifeSciences Corp.·May 31, 2023
HENRY SCHEIN, VEIN TRAY, Item No.570-2738,
FDA Enforcement
Class II
·Ongoing·Stradis Medical, LLC dba Stradis Healthcare·December 21, 2022
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
FDA Enforcement
Class II
·Ongoing·Wright Medical Technology, Inc.·May 3, 2023
Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L YELLOW LIDO Model/Catalog Number: 91877 Product Description: NON-Sterile syringes without needles for single use Component: No
FDA Enforcement
Class II
·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024
DeRoyal BASIC NEURO PACK, REF 89-7523.15
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
Brand Name: MEDLINE Product Name: SYR 5ML L/L RED Model/Catalog Number: 91825 Product Description: NON-Sterile syringes without needles for single use Component: No
FDA Enforcement
Class II
·Ongoing·Jiangsu Shenli Medical Production Co., Ltd.·May 29, 2024