7 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·November 6, 2024
Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
FDA Enforcement
Class II
·Ongoing·Jewel Precision Sheet Metal & Machining Co, Inc.·July 2, 2025
Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
FDA Enforcement
Class II
·Ongoing·Jewel Precision Sheet Metal & Machining Co, Inc.·July 2, 2025
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
FDA Enforcement
Class II
·Ongoing·Canadian Hospital Specialties Ltd.·July 24, 2024
microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.
FDA Enforcement
Class I
·Ongoing·FHC, Inc.·November 20, 2024
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292
FDA Enforcement
Class III
·Ongoing·DRG International, Inc.·November 6, 2024
Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA¿ - Liatest ¿ D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R¿, STA Compact¿ and STA Satellite¿ analyzers by professional laboratory personnel. The STA¿ - Liatest¿ D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: No
FDA Enforcement
Class II
·Ongoing·Diagnostica Stago, Inc.·March 25, 2026