49 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
FDA Enforcement
Class II
·Ongoing·LeMaitre Vascular, Inc.·May 21, 2025
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard.
FDA Enforcement
Class II
·Ongoing·Insulet Corporation·October 22, 2025
Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod 5 iOS App software is available to download through the Apple app store. The Omnipod 5 App is the user interface that controls the Omnipod 5 Automated Insulin Delivery System. It is used to activate/deactivate Pods, display alerts/alarms, and send insulin delivery commands for execution to the Pod. Only available in the US.
FDA Enforcement
Class II
·Ongoing·Insulet Corporation·July 2, 2025
C9-3io Transducer Probe
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·September 3, 2025
L15-7io Transducer Probe
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·September 3, 2025
L15-7IO TRANSDUCER Transducer Probe
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·September 3, 2025
LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
FDA Enforcement
Class II
·Ongoing·LINK BIO CORP·July 31, 2024
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories·April 3, 2024
3mensio Workstation (Vascular Fenestrated) software
FDA Enforcement
Class II
·Ongoing·PIE Medical Imaging B.V.·August 20, 2025
Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood specimens.
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc.·September 10, 2025
Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
FDA Enforcement
Class II
·Ongoing·SCIENCE & BIO MATERIALS·May 14, 2025
VACUETTE SAFELINK, REF: 450210
FDA Enforcement
Class II
·Ongoing·Greiner Bio-One GmbH·January 15, 2025
CMV IgM EIA, in vitro diagnostic.
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc.·December 7, 2022
EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc·July 10, 2019
BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma.
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc.·September 30, 2020
BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc.·March 23, 2022
Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc.·June 8, 2022
BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of nontreponemal reagin antibodies in human serum or plasma
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc.·November 24, 2021
BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc.·March 23, 2022
BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc.·May 25, 2022