Data / Medical devices / Device, Biopsy, Endomyocardial
Device, Biopsy, Endomyocardial (DWZ): 12 FDA-registered makers in 3 countries
12 establishments in 3 countries are registered with the FDA to make Device, Biopsy, Endomyocardial (product code DWZ, Class 2, 21 CFR 870.4075). 8 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 23 510(k) clearances under this code, the latest on September 30, 2025, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DWZ
- Device class
- 2
- Regulation
- 870.4075
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Germany | 2 |
| Mexico | 1 |
Makers of Device, Biopsy, Endomyocardial
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 |
|---|---|---|---|---|---|---|---|---|
| Cordis US Corp. | Miami Lakes, FL, United States | Complaint file establishment, Specification developer | 2 | January 6, 1994 | 0 | 0 | 0 | api.fda.gov |
| Argon Medical Devices Inc. | Athens, TX, United States | Manufacturer | 1 | July 27, 1995 | 0 | 0 | 0 | api.fda.gov |
| Atc Technologies Inc. | Wilmington, MA, United States | Contract manufacturer, Manufacturer | 1 | June 6, 2001 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 1 | December 5, 1988 | 0 | 0 | 0 | api.fda.gov |
| FEHLING INSTRUMENTS GmbH | KARLSTEIN Bavaria, Germany | Complaint file establishment, Exporter to the US, Manufacturer | 1 | June 2, 2017 | 0 | 0 | 0 | api.fda.gov |
| Lake Region Medical | Chaska, MN, United States | Manufacturer | 1 | November 5, 1999 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Specification developer | 1 | October 3, 2007 | 0 | 0 | 0 | api.fda.gov |
| St. Jude Medical, Atrial Fibrillation Division, Inc. | Minnetonka, MN, United States | Specification developer | 1 | November 5, 1999 | 0 | 0 | 0 | api.fda.gov |
| Guenter Stoffel Medizintechnik GMBH | WURMLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merit Maquiladora Mexico, S. DE R.L. DE C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Norman Noble, Inc. | Highland Heights, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant AS&O Holdings, LLC | Laconia, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 30, 2025. 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.