Covidien Medical Products (Shanghai) Manufacturing LLC
Shanghai, CN
Covidien Medical Products (Shanghai) Manufacturing LLC appears in FDA device records in Shanghai, CN. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006451981 | 3006451981 | Covidien Medical Products (Shanghai) Manufacturing LLC | Building #10, 1st Floor of Building #6, 2nd Floor of Building #15, 789 Puxing Road, 201114, Shanghai 201114 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DQYCatheter, Percutaneous
- QJPCatheter, Percutaneous, Neurovasculature
- NRYCatheter, Thrombus Retriever
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- KARIrrigator, Sinus
- POLNeurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
- GDWStaple, Implantable
- NEYSystem, Ablation, Microwave And Accessories
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1187-2016 | Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with Thermosphere" Technology; The product is packaged in a blister with a tyvek lid, contained in a display box. The numbers of units per carton is 1. Long Percutaneous Antenna with Thermosphere" Technology Product Usage: The Covidien Emprint Ablation System is intended for use in percutaneous,laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors. The CovidienEmprint Ablation System is not intended for use in cardiac procedures | Medtronic is voluntarily recalling specific item codes and production lots of Covidien Emprint" Percutaneous Antenna with Thermosphere" Technology due to the potential for the generator to shut down in the precence of high temperature measurements in the Emprint" Percutaneous Antenna. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain