295 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Brand Name: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor: Single day Infusor 2 ml/h, Single Day INFUSOR 2 ml/h System, Half Day INFUSOR SV 5 ml/h System, Two Day INFUSOR 2 ml/h System, Two day Infusor 2 ml/h, Multiday Infusor 0.5 ml/h, Multiday INFUSOR 0.5ml/h System, Seven Day Infusor 0.5 ml/h, Seven Day INFUSOR 0.5ml/h System, Basal-Bolus Infusor-15min., Basal/Bolus INFUSOR 0.5 x 2 ml/h System with 15 Minute Lockout, Basal-Bolus Infusor Device Listing: D018045 The Multiday lnfusor. Seven Day lnfusor and the BasaVBolus lnfusor are indicated for patients requiring slow, continuous intravenous, intra-arterial, subcutaneous or epidural administration of medications.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corp.·July 3, 2013
Melatonin Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
VS200 radiographic Cassette Holder or Wall Stand. For use in radiology department.
FDA Enforcement
Class II
·Terminated·Del Medical, Inc.·February 17, 2016
VS300 radiographic Cassette Holder or Wall Stand. For use in radiology department.
FDA Enforcement
Class II
·Terminated·Del Medical, Inc.·February 17, 2016
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
FDA Enforcement
Class II
·Ongoing·Copan Italia·December 24, 2025
PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples
FDA Enforcement
Class II
·Ongoing·Entopsis , Inc.·April 5, 2023
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584550;
FDA Enforcement
Class II
·Ongoing·Beaver Visitec International, Inc.·September 4, 2024
EasyTouch (ET) Insulin Syringe 29G 1ml ¿" (Item 829155) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
FDA Enforcement
Class II
·Ongoing·MHC Medical Products LLC·May 16, 2018
Medicina Oral Tip Syringe 1ml Code: OT01
FDA Enforcement
Class II
·Ongoing·Medicina Uk Ltd·October 26, 2022
Medicina Reusable Oral syringe 1ml Code: OTH01
FDA Enforcement
Class II
·Ongoing·Medicina Uk Ltd·October 26, 2022
Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens.
FDA Enforcement
Class II
·Terminated·Gibson Laboratories LLC·February 21, 2018
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-Away Specimen Processor for Microbiology) System
FDA Enforcement
Class II
·Ongoing·Copan Italia·December 24, 2025
Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·March 7, 2018
BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326719
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Company·March 22, 2023
Brand Name: MEDLINE Product Name: SYR 1ML TB Model/Catalog Number: 83089 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
Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test, RX only, IVD, CE
FDA Enforcement
Class II
·Ongoing·Immuno-Mycologics, Inc·March 26, 2025
Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD
FDA Enforcement
Class II
·Ongoing·Medicina Uk Ltd·October 26, 2022
Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·October 25, 2023
BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326678
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Company·March 22, 2023
BD Insulin Syringes with the BD Micro-Fine TM IV Needle 1ml, 12.7mm, 28G Single Unit Scale. Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329420
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Company·March 22, 2023