52 results
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Sources: EU EUDAMED, US FDA
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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
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
FDA Enforcement
Class II
·Ongoing·Ohio Medical Corporation·June 25, 2025
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
FDA Enforcement
Class II
·Ongoing·Murata Vios, Inc.·February 19, 2025
Vios Monitoring System Bedside Monitor Model BSM2050
FDA Enforcement
Class II
·Ongoing·Murata Vios, Inc.·March 12, 2025
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
FDA Enforcement
Class II
·Ongoing·Murata Vios, Inc.·February 5, 2025
LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
FDA Enforcement
Class II
·Ongoing·LINK BIO CORP·July 31, 2024
Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps, part #AI5511, a component of model numbers 756000 and 757000.
FDA Enforcement
Class II
·Ongoing·Ohio Medical Corporation·January 19, 2022
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories·April 3, 2024
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