510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Angiomed GmbH & Co. Medizintechnik KG

KARLSRUHE Baden-Wurttemberg, DE

ANGIOMED GMBH & CO. MEDIZINTECHNIK KG appears in FDA device records in KARLSRUHE Baden-Wurttemberg, DE. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
7
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Angiomed GmbH & Co. Medizintechnik KG carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Angiomed Gmbhrecall

510(k) clearance history

FDA records hold 1 510(k) clearance for Angiomed GmbH & Co. Medizintechnik KG in 1992.

Clearances by year, as a table
510(k) clearance decisions for Angiomed GmbH & Co. Medizintechnik KG, by decision year
YearClearances
19921
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K912892AUTO-VAC BIOPSY NEEDLEKNWSubstantially Equivalent

Registered establishments

FDA registered establishments for Angiomed GmbH & Co. Medizintechnik KG, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96814423002806368ANGIOMED GMBH & CO. MEDIZINTECHNIK KGWACHHAUSSTRASSE 6, KARLSRUHE Baden-Wurttemberg 76227 DE2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1583-05Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 10 mm x100 mm Catalog Number: LXB10100Biliary Stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation.Terminated
Z-1582-05Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 10 mm x 80 mm Catalog Number: LXB10080Biliary Stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation.Terminated
Z-1581-05Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 10 mm x 60 mm Catalog Number: LXB10060Biliary Stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation.Terminated
Z-1580-05Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 10 mm x 40 mm Catalog Number: LXB10040Biliary Stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation.Terminated
Z-1579-05Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 8 mm x 100 mm Catalog Number: LXB080100Biliary Stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation.Terminated
Z-1578-05Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 8 mm x 80 mm Catalog Number: LXB08080Biliary Stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation.Terminated
Z-1577-05Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 8 mm x 60 mm Catalog Number: LXB08060Biliary Stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation.Terminated

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Angiomed GmbH & Co. Medizintechnik KG edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain