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Data / Medical devices / Switzerland / Schiller AG

Schiller AG: FDA-registered device maker in BAAR Zug, Switzerland, 15 510(k) clearances

Schiller AG is registered with the FDA (registration 8030978) in BAAR Zug, Switzerland. It lists 16 device types. The FDA files 15 510(k) clearances under its listings, the newest dated August 14, 2026. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Schiller AG
FDA registration number
8030978
FEI number
3002808182
Address
Altgasse 68, BAAR Zug, Switzerland, 6341
Owner or operator
SCHILLER AG (8030978)
Roles
Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer
First device listed
July 10, 1981
Registered through
2026
Brand names listed
ARGUS PB-1000; ARGUS PB-2000, ARGUS PB-3000, BP-200 plus, CARDIOVIT AT-10 plus (SEMA200), CARDIOVIT AT-101, CARDIOVIT AT-102, CARDIOVIT AT-102 G2, CARDIOVIT AT-180 and more

Devices it lists

DeviceProduct codeClassRoleSource
Aid, Cardiopulmonary ResuscitationLIX2Manufactureraccessdata.fda.gov
Computer, Diagnostic, ProgrammableDQK2Manufactureraccessdata.fda.gov
Dc-Defibrillator, Low-Energy, (Including Paddles)LDD2Manufactureraccessdata.fda.gov
Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) ClinicaJQT1Exporter to the USaccessdata.fda.gov
ElectrocardiographDPS2Manufactureraccessdata.fda.gov
Electrocardiograph, Ambulatory (Without Analysis)MWJ2Manufactureraccessdata.fda.gov
LOSLOSManufactureraccessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)MHX2Contract manufacturer, Foreign private label distributor, Manufactureraccessdata.fda.gov
Mouthpiece, BreathingBYP1Manufactureraccessdata.fda.gov
OximeterDQA2Manufactureraccessdata.fda.gov
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)DRO2Manufactureraccessdata.fda.gov
Recorder, Magnetic Tape, MedicalDSH2Manufactureraccessdata.fda.gov
Recorder, Paper ChartDSF1Manufactureraccessdata.fda.gov
Scale, Stand-On, PatientFRI1Exporter to the USaccessdata.fda.gov
Spirometer, DiagnosticBZG2Manufactureraccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 14, 2026K253562medilogFDMWJSubstantially EquivalentSchiller AGaccessdata.fda.gov
July 6, 2023K221056ARGUS PB-3000MHXSubstantially EquivalentSchiller AGaccessdata.fda.gov
July 24, 2020K200849Tempus LS - ManualLDDSubstantially EquivalentRemote Diagnostic Technologies, Ltd. A Philips Companyaccessdata.fda.gov
March 2, 2020K183425CARDIOVIT AT-102 G2DPSSubstantially EquivalentSchiller AGaccessdata.fda.gov
July 19, 2017K170182CARDIOVIT FT-1DPSSubstantially EquivalentSchiller AGaccessdata.fda.gov
May 6, 2016K152043Diagnostic Station DS20DPSSubstantially EquivalentSchiller AGaccessdata.fda.gov
April 6, 2007K070818MEDILOGAR4, MEDILOGAR12DSHSubstantially EquivalentTom Medical Entwicklungs GmbHaccessdata.fda.gov
March 7, 2007K063814BP-200 PLUSDXNSubstantially EquivalentSchiller AGaccessdata.fda.gov
December 22, 2005K053369MEDILOG DARWIN HOLTER ANALYSISDQKSubstantially EquivalentHuntleigh Healthcareaccessdata.fda.gov
May 4, 2005K050686CARDIOVIT AT-10PLUSDPSSubstantially EquivalentSchiller AGaccessdata.fda.gov
April 14, 2004K031557CARDIOVIT AT-102DPSSubstantially EquivalentSchiller AGaccessdata.fda.gov
April 8, 2002K012226MONITORING SYSTEM,MODEL ARGUS PB-1000MHXSubstantially EquivalentSchiller AGaccessdata.fda.gov
April 30, 1999K984031SPIROVIT, MODEL SP-250BZGSubstantially EquivalentSchiller AGaccessdata.fda.gov
June 25, 1997K970879CARDIOVIT CS-200LOSSubstantially EquivalentSchiller America, Inc.accessdata.fda.gov
December 19, 1995K953396CARDIOVIT AT-1C, AT-2CLOSSubstantially EquivalentSchiller America, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
August 8, 202597451Class IIOngoingArgus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in the high-pressure range.accessdata.fda.gov
July 24, 202495074Class IIOngoingCARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.accessdata.fda.gov

Compare with other makers

Updated August 14, 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.