11 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i) NM/CT 870 CZT O540+ 7.25MM; Emission Computed Tomography System
FDA Enforcement
Class I
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·February 15, 2023
Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated reamer, sterile.
FDA Enforcement
Class II
·Ongoing·Arthrex, Inc.·December 14, 2022
Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
FDA Enforcement
Class II
·Ongoing·Carl Zeiss Meditec, Inc.·August 18, 2021
GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·January 20, 2021
CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
FDA Enforcement
Class II
·Ongoing·Carl Zeiss Meditec, Inc.·March 16, 2022
GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 22, 2025
Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
FDA Enforcement
Class II
·Ongoing·Gentuity, LLC·April 22, 2026
OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
FDA Enforcement
Class II
·Ongoing·Haag-Streit USA Inc·January 19, 2022
OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
FDA Enforcement
Class II
·Ongoing·Haag-Streit USA Inc·January 19, 2022
Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-FTAP-40-MDN 26-FTAP-45-MDN 26-S-FINDER-MDN Components of a surgical navigation device.
FDA Enforcement
Class II
·Ongoing·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·November 11, 2020
Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF: PC2-400013; Navigation, 3.5mm Drill, REF: PC2-400135; Navigation, 4.0mm Drill, REF: PC2-400140; Navigation, 4.5mm Drill, PC2-400145; Navigation, 5.5mm Drill, REF: PC2-400155; Navigation, 3.5mm Tap, REF: PC2-400235; Navigation, 4.0mm Tap, REF: PC2-400240; Navigation, 4.5mm Tap, REF: PC2-400245; Navigation, 4.5mm Dual Lead Tap, REF: PC2-400345; Navigation, 5.5mm Dual Lead Tap, REF: PC2-400355
FDA Enforcement
Class II
·Ongoing·SEASPINE ORTHOPEDICS CORPORATION·December 24, 2025