14 results
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11ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained healthcare professionals and clinicians to access archived multimedia data, forms and patient information.
FDA Enforcement
Class II
·Terminated·Topcon Medical Systems, Inc.·February 10, 2021
Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASIC PACK - 205939 ANIR77AM INTERVENTIONAL RADIOLOGY PACK - 205953 CFLA39G LAPAROTOMY PACK CIBL33I BASIC LAP PACK EVMN24E MINOR ESC EVST48E STARTER FDTA11AA T & A PACK FHHY25P HYSTEROSCOPY PACK HGML99G MAJOR LAP PACK HGXR41H X-RAY PACK HISU54M SET-UP PACK IHAA19AP PK A A A IHMP89K MINOR PROCEDURE PACK IHPD14AM PK PEDIATRIC LKVG10O VAG DELIVERY LMAG20G VASCULAR PACK LMLE46AA EXTREMITY LOWER PK MIEN58A DTC GENERAL ENDOSCOPY PACK(PS 209468) NUMB04H MAJOR BASIN SET 314666 OWBS11U BASIN SET - 206021 RCMS71B MIS SPECIALTY RCH SFMB55X MINOR BASIN - 208293 STBA09F BASIN SET TNBS21O BASIN SET 612833 UDBH37AX BASIC HEART PACK - 206044 UDMA50X MINOR ADULT - 206067 UICR54W ACS CRS PACK (PS055042) UIPC89D PROCUREMENT PACK UIPT13F PITCHER (PS 907953) UISB96AB SMALL BACK TABLE SETUP (PS 907419)
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc.·October 22, 2025
GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·May 15, 2024
GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·May 15, 2024
GE Healthcare Innova IGS 5, computed tomography x-ray system
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·May 15, 2024
GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·May 15, 2024
GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·May 15, 2024
GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·May 15, 2024
GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·May 15, 2024
Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
FDA Enforcement
Class II
·Terminated·GE Medical Systems, SCS·July 18, 2018
Discovery IGS 730 Interventional Fluoroscopic X-ray Systems
FDA Enforcement
Class II
·Terminated·GE Medical Systems, SCS·July 18, 2018
Discovery IGS 740 Interventional Fluoroscopic X-ray Systems
FDA Enforcement
Class II
·Terminated·GE Medical Systems, SCS·July 18, 2018
Senographe Pristina
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·February 14, 2024
AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·October 15, 2025