Data / Medical devices / Dilator, Vessel, Surgical
Dilator, Vessel, Surgical (DWP): 23 FDA-registered makers in 3 countries
23 establishments in 3 countries are registered with the FDA to make Dilator, Vessel, Surgical (product code DWP, Class 2, 21 CFR 870.4475). 12 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 20 510(k) clearances under this code, the latest on April 20, 2023, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DWP
- Device class
- 2
- Regulation
- 870.4475
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 13 |
| Germany | 9 |
| Pakistan | 1 |
Makers of Dilator, Vessel, Surgical
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 2 | August 31, 2010 | 0 | 0 | 0 | api.fda.gov |
| SYNOVIS LIFE TECHNOLOGIES, INC. (A Subsidiary of Baxter International Inc.) | Saint Paul, MN, United States | Manufacturer | 2 | April 24, 2013 | 0 | 0 | 0 | api.fda.gov |
| AVALIGN TECHNOLOGIES, Inc. | Fort Wayne, IN, United States | Specification developer | 1 | August 31, 2010 | 0 | 0 | 0 | api.fda.gov |
| FEHLING INSTRUMENTS GmbH | KARLSTEIN Bavaria, Germany | Manufacturer | 1 | April 20, 2023 | 0 | 0 | 0 | api.fda.gov |
| Fetzer Surgical, LLC | Scottsdale, AZ, United States | Repackager or relabeler, Specification developer | 1 | June 29, 2017 | 0 | 0 | 0 | api.fda.gov |
| Geister Medizintechnik GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer, Specification developer | 1 | July 12, 2003 | 0 | 0 | 0 | api.fda.gov |
| Geomed Medizin-Technik GMBH & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 1 | September 3, 2019 | 0 | 0 | 0 | api.fda.gov |
| Instrumed International Inc dba Avalign German Specialty Instruments | Schaumburg, IL, United States | Contract manufacturer, Repackager or relabeler | 1 | August 31, 2010 | 0 | 0 | 0 | api.fda.gov |
| LivaNova USA, INC. | Arvada, CO, United States | Specification developer | 1 | December 4, 1979 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 1 | August 31, 2010 | 0 | 0 | 0 | api.fda.gov |
| STERIS Corporation | Saint Louis, MO, United States | Complaint file establishment, Manufacturer | 1 | August 31, 2010 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 1 | August 31, 2010 | 0 | 0 | 0 | api.fda.gov |
| Apex Medical Technologies, Inc. | San Diego, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| August Reuchlen GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alleima Karlsruhe GmbH | Karlsruhe Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fetzer Medical GMBH & Co.kg | Tuttlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instrumed GmbH dba Avalign German Specialty Instruments | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phoenix Instruments, Inc. | Lisle, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qsa Surgical (pvt) Ltd. | SIALKOT Punjab, Pakistan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scanlan International, Inc. | Saint Paul, MN, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tontarra Medizintechnik GMBH | WURMLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| WILDmedical GmbH | Tuttlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 20, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.