12 results
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8ms
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Sources: EU EUDAMED, US FDA
Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
FDA Enforcement
Class II
·Terminated·Fujifilm Medical Systems U.S.A., Inc.·September 30, 2015
Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.
FDA Enforcement
Class II
·Terminated·Fujifilm Medical Systems U.S.A., Inc.·September 30, 2015
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
FDA Enforcement
Class II
·Terminated·Philips Healthcare·April 13, 2022
Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·December 21, 2016
Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery
FDA Enforcement
Class II
·Terminated·Teleflex Medical·August 24, 2016
Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX Only, CE0482, (01)10709078008020 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
FDA Enforcement
Class II
·Terminated·Westmed, Inc.·January 6, 2021
StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.
FDA Enforcement
Class II
·Terminated·Dental EZ Stardental Division·June 19, 2013
Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is used with an air drive scaler for subgingival scaling and fine access. The Perio tip is used for lingual supragingival scaling of mandibular incisors and deep local pockets.
FDA Enforcement
Class II
·Ongoing·Dental EZ Group Star Dental Division·July 3, 2024
Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number 261669) (1) P/N 264563 (2) P/N 264565 The scaler tip is used with an air drive scaler for subgingival scaling and fine access. The Perio tip is used for lingual supragingival scaling of mandibular incisors and deep local pockets.
FDA Enforcement
Class II
·Ongoing·Dental EZ Group Star Dental Division·July 3, 2024
Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform a variety of dental procedures including caries removal, finishing, polishing, pin setting and prophy.The motor has a speed range of 100 to 5000 rpm capability.
FDA Enforcement
Class II
·Terminated·Dental EZ Group Star Dental Division·July 23, 2014
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
FDA Enforcement
Class II
·Terminated·NEUSOFT MEDICAL SYSTEMS IMP & EX·February 13, 2019
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·December 24, 2025