Skip to content

Biotronik Sales, Inc.

United StatesFDA applicant, unverified

Devices
41

What Biotronik Sales, Inc. makes

Biotronik Sales, Inc. manufactures cardiac pacing devices, including unipolar and endocardial leads (such as the DN UNIPOLAR PE-60/4-DN and TYPE YR), as well as pulse generators (e.g., the NEOS-M VS-1 and NEOS-LP). Their portfolio also covers pacemaker systems like the EDP-20 and standalone pulse generators, designed for permanent cardiac rhythm management.

These devices fall under FDA Class II and Class III classifications, with regulatory clearance via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue41

Newest first, rows 1-41 of 41

Search and filter all 41 devices
Skip device list

  • Biotronik Dn Unipolar Pe-60/4-Dn & Ref K833098

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Biotronik D2K Unipolar Pe-60/4 Ref K833104

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Leptos Ref K841635

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Edp-20 Pacemaker Ref K860036

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Pulse Generator Ref K821073

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Biotronik Permanent Pacemaker Electrode Ref K863480

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Neos-M Vs-1 Pulse Generator Ref K863879

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Type Yr Endocardial Lead Ref K810492

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Biotronik Dy-Unipolar Ref K841451

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Neds-01 & Epr-500 Ref K830862

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Neos-LP Pulse Generator Ref K844842

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Type Fh Endocardial Lead Ref K810494

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Neos M Ref K841636

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Implantable, Multiprogrammable Ref K820774

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Mikros, Mikros Vs-1, Pulse Generator Ref K860922

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Kalos-04 Pulse Generator Ref K844841

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Biotronik I-Unipolar Pe-60/2-13 Ref K833108

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Type N Endocardial Lead Ref K810493

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Trios-M Vs-1 Pulse Generator Ref K863878

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Pulse Generator Kalos-04 Ref K841950

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Neos - Pulse Generator Ref K844812

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Dnr Unipolar Ref K853568

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Epr-200 Programmer Model 010 Ref K800376

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Biotronik Dyc, Unipolar Pe-60/4-Dyc Ref K833101

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Dj Unipolar Ref K853566

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Type Yc Endocardial Lead Ref K810491

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Np Bipolar Endocardial Lead W/Vs-1 Connector Ref K875199

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Djp Unipolar Ref K853567

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Biotronik Dnp Unipolar Ref K841450

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Neos - M Abp Ref K853058

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Neos LP Ref K841633

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Nomos-01 Pulse Generator Ref K800375

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Leptos Pulse Generator Ref K844794

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Biotronik N, Bipolar Peb-60/4-N Ref K833099

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Era-20 Ref K853194

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Neos Vs-1, Pulse Generator Ref K860921

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Kalos-03 Ref K812218

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Neos-M Pulse Generator Ref K844795

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Biotronik Dfh Unipolar Pe-60/4-Dfh Ref K833106

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Kalos-03 Bipolar Ref K822907

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Trios - M Ref K853057

    Active Regimes: 510(k) Registry: 510(k) Class:III

Rows 1-41 of 41

Frequently asked questions

How many devices does Biotronik Sales, Inc. have in the registry?

The registry currently lists 41 devices for Biotronik Sales, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Biotronik Sales, Inc.'s devices?

Among its 41 most recently registered devices, Biotronik Sales, Inc. has devices listed in FDA 510(k) (41 devices).

What risk classes do Biotronik Sales, Inc.'s devices fall under?

Among its 41 most recently registered devices, the classes recorded for Biotronik Sales, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.

What are the newest devices from Biotronik Sales, Inc. in the registry?

The most recently registered devices listed for Biotronik Sales, Inc. include BIOTRONIK DN UNIPOLAR PE-60/4-DN &, BIOTRONIK D2K UNIPOLAR PE-60/4, LEPTOS and EDP-20 PACEMAKER.

Generated automatically from registry data and not verified by a human reviewer.