104 results
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7ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD, H2508PA, H2508PB, H2508PC, H2508PD. Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·November 19, 2014
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
FDA Enforcement
Class II
·Ongoing·Orthalign, Inc·April 1, 2026
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
FDA Enforcement
Class II
·Ongoing·Orthalign, Inc·April 1, 2026
EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·March 18, 2026
Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragments Intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 12, 2018
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Description: Feeding Tube Kit Component: No
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catalog Number: 8170-20
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/Catalog Number: 8170-24
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 Product Description: Feeding Tube Kit
FDA Enforcement
Class II
·Ongoing·Avanos Medical, Inc.·June 17, 2026
Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112.018.06, Sterile, a component of the Unity Total Knee System.
FDA Enforcement
Class II
·Terminated·Corin Ltd·October 6, 2021
Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr
FDA Enforcement
Class II
·Terminated·Pdg Product Design Group Inc·October 1, 2014
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Enforcement
Class II
·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Enforcement
Class II
·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Enforcement
Class II
·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020