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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