Data / Medical devices / Germany / Angiomed GMBH & Co. Medizintechnik KG
Angiomed GMBH & Co. Medizintechnik KG: FDA-registered device maker in KARLSRUHE Baden-Wurttemberg, Germany, 5 510(k) clearances and 5 PMA approvals
Angiomed GMBH & Co. Medizintechnik KG is registered with the FDA (registration 9681442) in KARLSRUHE Baden-Wurttemberg, Germany. It lists 8 device types. The FDA files 5 510(k) clearances and 5 PMA approvals under its listings, the newest dated September 25, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9681442
- FEI number
- 3002806368
- Address
- Wachhausstrasse 6, KARLSRUHE Baden-Wurttemberg, Germany, 76227
- Owner or operator
- C. R. Bard, Inc. (2212754)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- December 16, 1999
- Registered through
- 2027
- Brand names listed
- Bard Fluoro-4 Silicone Ureteral Stent, Bard Lubricious-Coated Ureteral, Bardex Double Pigtail Stent, Bardex Double Pigtail Ureteral Stent with Suture, Coil Stent, Covera Vascular Covered Stent, E-LUMINEXX Biliary Stent System, E-Luminexx Vascular Stent System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | 2 | Contract manufacturer | accessdata.fda.gov |
| Shunt, Portosystemic, Endoprosthesis | MIR | 3 | Manufacturer | accessdata.fda.gov |
| Stent, Iliac | NIO | 3 | Manufacturer | accessdata.fda.gov |
| Stent, Iliac Vein | QAN | 3 | Manufacturer | accessdata.fda.gov |
| Stent, Superficial Femoral Artery | NIP | 3 | Manufacturer | accessdata.fda.gov |
| Stent, Ureteral | FAD | 2 | Contract manufacturer | accessdata.fda.gov |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment | PFV | 3 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 30, 2013 | K130792 | LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM | FGE | Unknown | C.R. Bard, Inc. | accessdata.fda.gov |
| May 30, 2008 | K063532 | BARD E LUMINEXX BILIARY STENT | FGE | Unknown | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| March 23, 2006 | K060487 | LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM | FGE | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| December 21, 2005 | K053404 | LIFESTENT FLEXSTART BILIARY STENT SYSTEM | FGE | Unknown | Edwards Lifesciences, LLC | accessdata.fda.gov |
| May 6, 2003 | K031186 | LUMINEXX ENDOSCOPIC BILIARY STENT | FGE | Unknown | C.R. Bard, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 25, 2026 | P250050 | Liverty TIPS Stent Graft | MIR | 1 | October 23, 2026 | accessdata.fda.gov |
| March 13, 2019 | P180037 | Venovo Venous Stent System | QAN | 14 | June 10, 2026 | accessdata.fda.gov |
| July 30, 2018 | P170042 | Covera Vascular Covered Stent | PFV | 14 | June 10, 2026 | accessdata.fda.gov |
| February 13, 2009 | P070014 | LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM | NIP | 66 | June 10, 2026 | accessdata.fda.gov |
| December 4, 2008 | P080007 | BARD E-LUMINEXX VASCULAR STENT | NIO | 24 | May 26, 2022 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 28, 2005 | 32853 | Not yet classified | Terminated | Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR, 8 mm x 60 mm Catalog Number: LXB08060 | Biliary Stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation. | accessdata.fda.gov |
Compare with other makers
- All makers of Shunt, Portosystemic, Endoprosthesis
- All makers of Stent, Iliac Vein
- All makers of Stent, Ureteral
- All makers of Stent, Superficial Femoral Artery
- All makers of System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
- All makers of Stents, Drains And Dilators For The Biliary Ducts
Updated October 23, 2026. 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.