Covidien Medical Products (Shanghai) Manufacturing LLC
Registered establishment in Shanghai, China. 8 device types.
Covidien Medical Products (Shanghai) Manufacturing LLC is a contract manufacturer holding a current FDA establishment registration. The registration covers Irrigator, Sinus, Staple, Implantable and 6 other device types. Its earliest product listing with the FDA dates from 1992.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3006451981 |
| FEI number | 3006451981 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | Building #10, 1st Floor of Building #6, 2nd Floor of Building #15, 789 Puxing Road, 201114 |
| Postal code | 201114 |
| Country | China |
Group
Covidien Medical Products (Shanghai) Manufacturing LLC is one of 2 plants registered under Covidien llc.
| Plant | City | Device types |
|---|---|---|
| Medtronic (Shanghai) Medical Technology Co., Ltd. | Min Hang District | 4 |
What It Makes
Clearances
No clearance names Covidien Medical Products (Shanghai) Manufacturing LLC as applicant. 14 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K163105 | 2016-12-06 | NEY | Special | Covidien |
| K160331 | 2016-08-12 | GEI | Traditional | Covidien |
| K152286 | 2015-09-08 | GEI | Special | Covidien |
| K143654 | 2015-04-03 | GEI | Traditional | Covidien |
| K133821 | 2014-04-28 | NEY | Traditional | Covidien |
| K113572 | 2012-09-05 | GEI | Traditional | Covidien, Formerly Valleylab, A Division of Tyco H |
| K091223 | 2009-09-11 | GEI | Traditional | Covidien LP |
| K043273 | 2005-01-05 | GEI | Traditional | Valleylab, Inc. |
| K031011 | 2003-05-29 | GEI | Traditional | Valleylab, Inc. |
| K010013 | 2001-03-26 | GEI | Traditional | Valleylab, Inc. |
| K001895 | 2000-12-08 | GDW | Traditional | United States Surgical, A Division of Tyco Healthc |
| K953195 | 1995-08-21 | GEI | Traditional | Valleylab, Inc. |
| K944602 | 1995-06-05 | GEI | Traditional | Valleylab, Inc. |
| K791752 | 1979-10-04 | GEI | Traditional | Valleylab, Inc. |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-02-23 | Class II | Nonconforming Material/Component | 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 measu | 4,920 units | 2017-06-21 |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.