113 results
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Sources: EU EUDAMED, US FDA
Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing one assay item by visually or instrumentally reading the color change of the pad and comparing with the corresponding blocks on a color chart. The Healgen Series Reagent Strips for Urinalysis provides tests for Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Ascorbic Acid and Leukocytes in Urine.
FDA Enforcement
Class II
·Ongoing·Healgen Scientific Llc·October 9, 2024
GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within a computer network or on a workstation.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·July 13, 2022
RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
FDA Enforcement
Class II
·Ongoing·Cytocell Ltd.·July 26, 2023
RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
FDA Enforcement
Class II
·Ongoing·Cytocell Ltd.·July 26, 2023
Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
FDA Enforcement
Class II
·Ongoing·Microtek Medical Inc.·August 28, 2024
Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
FDA Enforcement
Class II
·Ongoing·Microtek Medical Inc.·August 28, 2024
Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
FDA Enforcement
Class II
·Ongoing·Microtek Medical Inc.·August 28, 2024
Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
FDA Enforcement
Class II
·Ongoing·Microtek Medical Inc.·August 28, 2024
C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
FDA Enforcement
Class II
·Ongoing·Microtek Medical Inc.·August 28, 2024
Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a female luer with 15cm sealed SCD tubing, REF: 15-RF60-T
FDA Enforcement
Class II
·Ongoing·OriGen Biomedical, Inc.·February 21, 2024
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
Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317FT Product Usage: Soft tissue fixation to bone in the hand and wrist
FDA Enforcement
Class II
·Ongoing·Arthrex, Inc.·January 23, 2019
Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractable X-frame that is designed to support and transport a maximum weight of 700 lb (318 kg). Model Number: 6507
FDA Enforcement
Class II
·Ongoing·Stryker Medical Division of Stryker Corporation·July 19, 2023
Synapse PACS - Version 7.2.100
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·March 13, 2024
Synapse PACS - Version 7.1.000
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·March 13, 2024
Synapse PACS - Version 7.2.200
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·March 13, 2024
Synapse PACS - Version 7.2.000
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·March 13, 2024
Synapse PACS - Version 7.3.000
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·March 13, 2024
Synapse PACS - Version 7.1.000US
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·March 13, 2024
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
FDA Enforcement
Class II
·Ongoing·Brainlab AG·March 22, 2023