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Elema-Schonander, Inc.

United StatesFDA applicant, unverified

Devices
11

What Elema-Schonander, Inc. makes

Elema-Schonander, Inc. manufactures cardiac rhythm management devices including pacemakers, pulse generators, and programmers. Their product line consists of devices such as the PULSE GENERATOR MODEL 629, PUCK 90M, SEP PROGRAMMER FOR PUCK U & UD FILMCHANG, PACEMAKER 208S, and MPQ-42, among others.

The company's portfolio includes Class II and Class III medical devices, which are listed in the FDA 510(k) registry. Elema-Schonander, Inc. is based in the United States.

AI-generated from registry data, 24 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue11

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  • Lead Modification Ref K770135

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

  • Pulse Generator Model 629 Ref K790670

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

  • Puck 90M Ref K903576

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

  • Sep Programmer For Puck U & Ud Filmchang Ref K842903

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

  • Pulse Generator Model 637 Ref K790792

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

  • Sep Programmer Sep-M/Single-Plane & Ref K840389

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

  • Pacemaker 208S Ref K770005

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

  • Puck U & Ud Cutfilm Changers Ref K842911

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

  • Mpq-42 Ref K934944

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

  • Pulse Generator Model 208 Ref K781178

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

  • Sep 90 Ref K904103

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

Rows 1-11 of 11

Frequently asked questions

How many devices does Elema-Schonander, Inc. have in the registry?

The registry currently lists 11 devices for Elema-Schonander, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Elema-Schonander, Inc.'s devices?

Among its 11 most recently registered devices, Elema-Schonander, Inc. has devices listed in FDA 510(k) (11 devices).

What risk classes do Elema-Schonander, Inc.'s devices fall under?

Among its 11 most recently registered devices, the classes recorded for Elema-Schonander, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.

What are the newest devices from Elema-Schonander, Inc. in the registry?

The most recently registered devices listed for Elema-Schonander, Inc. include LEAD MODIFICATION, PULSE GENERATOR MODEL 629, PUCK 90M and SEP PROGRAMMER FOR PUCK U & UD FILMCHANG.

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