185 results
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58ms
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Sources: EU EUDAMED, US FDA
CY MEDICAL CO., LTD.
FDA registration
CY MEDICAL CO., LTD.·1 product·🇰🇷 South Korea
Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16. (10 syringes are packaged in a flexible plastic (poly bag) and 10 flexible plastic (poly bag) are packaged in one in box. Finally, pack the inboxes in the carton case.)
FDA Enforcement
Class II
·Terminated·ShinChang Medical Co., Ltd.·September 26, 2018
Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·BrosMed Medical Co.,Ltd.·March 6, 2019
Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, ES1815B, ES1610F, ES1612F, ES1615F, ES2006F, ES2008F, ES2010F; Esophageal TTS Stent, REF: EST1806F, EST2012F, EST2012B, EST2015F, EST2008F, EST1808F, EST1814F, EST1810F, EST2010F
FDA Enforcement
Class II
·Terminated·Taewoong Medical Co., Ltd.·February 19, 2020
COVID-19 ANTIGEN RAPID TEST
FDA Adverse Event
Malfunction
·EQUATE, DISTRIBUTED BY WALMART / ANDON MEDICAL CO., LTD.·Product code QYT·December 18, 2025
CMS8000 Patient Monitor
FDA Enforcement
Class II
·Ongoing·Contec Medical Systems Co., Ltd.·May 21, 2025
NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
FDA Enforcement
Class II
·Terminated·Neusoft Medical Systems Co., Ltd.·May 18, 2016
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
FDA Enforcement
Class II
·Terminated·Neusoft Medical Systems Co., Ltd.·January 4, 2017
NeuViz 64 Multi-slice CT Scanner Systems
FDA Enforcement
Class II
·Terminated·Neusoft Medical Systems Co., Ltd.·January 4, 2017
Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The 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 Co., Ltd.·September 6, 2017
Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version Product Usage: The 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 Co., Ltd.·September 6, 2017
NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The 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 Co., Ltd.·May 29, 2019
NeuViz 128 Multi-slice CT Scanner System Product Usage: The 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 Co., Ltd.·May 29, 2019
NeuViz 64 Multi-slice CT Scanner System Product Usage: The 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 Co., Ltd.·May 29, 2019
Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation.
FDA Enforcement
Class II
·Terminated·Laerdal Medical (Suzhou) Co., Ltd.·January 27, 2021
Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
FDA Enforcement
Class I
·Ongoing·DEWEI MEDICAL EQUIPMENT CO LTD·December 14, 2022
Winner Medical Co., Ltd.
System producer
🇨🇳 China
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
FDA Enforcement
Class II
·Ongoing·GE Medical Systems China Co., Ltd.·June 10, 2026
GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·December 24, 2025
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Carestation 750 A2, REF 1012-9750-002; Carestation 750c A1, REF 1012-9755-000; Products for which affected PMB can be used as a spare part: Carestation 750c A2, REF 1012-9755-002
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·December 24, 2025