8 results
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16ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024
K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
FDA Enforcement
Class II
·Ongoing·Kamiya Biomedical Company, LLC·November 30, 2022
K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R) Multi-Analyte Calibrator is intended to be used for the calibration of the K-ASSAY(R) Alpha-1 Acid Glycoprotein, Alpha-1 Anti-Trypsin, Complement C3, Complement C4, Haptoglobin, lgA, lgG, lgM, and Transferrin immunoturbidimetric assays. For in vitro diagnostic use
FDA Enforcement
Class II
·Terminated·Kamiya Biomedical Company, LLC·September 27, 2017
Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.
FDA Enforcement
Class II
·Terminated·NEOSTEO·August 18, 2021
Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
FDA Enforcement
Class II
·Terminated·Cook Inc.·April 4, 2018
cone-beam CT system
FDA Enforcement
Class II
·Ongoing·KaVo Dental Technologies LLC·May 1, 2019
DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-driven sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS / KaVo sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.
FDA Enforcement
Class II
·Terminated·KaVo Dental Technologies LLC·May 29, 2019
Helios HL3T and HLT Track Mounted Dental Lights Product Usage: The product is intended for use by dental professionals to illuminate the oral cavity while performing examinations and dental procedures.
FDA Enforcement
Class II
·Terminated·Pelton & Crane / Marus / DCI Equipment / KaVo·April 6, 2016