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Sedecal., SA.

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Sedecal., SA. is a medical device manufacturer, with 235 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I) and 53 FDA recalls as of 13 Nov 2026.

Devices
235
FDA recalls
5353 ongoing

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 209
  • EUDAMED 151
  • FDA 510(k) 26

A device listed in two registries counts in both.

Device classes
  • FDA Class II 134
  • FDA Class I 101
FDA recalls

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Sedecal., SA. makes

Sedecal manufactures a range of diagnostic x-ray equipment, including stationary, mobile, and portable systems in both digital and analogue configurations. The company also produces powered diagnostic x-ray system tables and x-ray film cassette holders.

These products are listed within the FDA 510(k) and FDA UDI regulatory registries.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue235

Newest first, rows 1-50 of 235

Search and filter all 235 devices
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  • Sedecal Net 4000-St

    Listed Registry: GUDID Class:II

  • Sedecal SHFR400

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • MobileDiagnost wDR 2.2 Ref K191813 Open recall

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

  • Sedecal Sm-40HF-B-D-C Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Sedecal Shf-210-C

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Sedecal Flexi-Dt

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:II

  • SEDECAL Proteus XR/f ST

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

  • Sedecal Spsl-Hf-8.0

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • SEDECAL PhoeniX

    Withdrawn Registry: GUDID Class:II

  • SEDECAL PhoeniX

    Withdrawn Registry: GUDID Class:II

  • Sedecal Shf-210PSU

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Sedecal SHFR300

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SEDECAL AeroDR TX m01 Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • SEDECAL Soltus 450 Open recall

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

  • Sedecal Shf-520

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Sedecal Shf-210

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Sedecal Cs Nova Fa

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Sedecal Shf-1635

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Sedecal Shf-525

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SEDECAL PhoeniX Open recall

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

  • Sedecal SHFR500

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Sedecal Shf-1620

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Sedecal Sm-V

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • SEDECAL PhoeniX

    Withdrawn Registry: GUDID Class:II

  • SEDECAL AeroDR TX m01 Open recall

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Sedecal SHFR100

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Sedecal Sm-Iv

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Sedecal Shf-0510-Mpsta

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Sedecal Shf-0510-M

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Sedecal Shf-1025

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Sedecal Spsl-Hf-4.0

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Sedecal Shf-615

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Sedecal Shf-610

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SEDECAL Proteus XR/f ST

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Sedecal Shf-1625

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Sedecal Shf-315

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Sedecal X Plus LP Plus

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Sedecal SHFR300

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • SEDECAL SM-50HF-B-D-KM (AeroDR X30)

    Withdrawn Registry: GUDID Class:II

  • Sedecal Hercules-65

    Withdrawn Registry: GUDID Class:I

  • Sedecal Shf-1610-C

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Sedecal SPSL8HC

    Listed Registry: GUDID Class:II

  • SEDECAL Proteus XR/f ET

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Sedecal X Brs (Brx) Open recall

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

  • Sedecal Shf-415-C

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Sedecal Sm-Iv

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Sedecal Shf-1615

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Sedecal Shf-515-C

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Sedecal Hercules-40

    Withdrawn Registry: GUDID Class:I

  • Sedecal Shf-220

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

Rows 1-50 of 235

Showing 1-50 of 235

FDA recalls53

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 53 recalls initiated by Sedecal., Sa., the earliest on 2021-10-14 and the most recent on 2025-06-10. By recorded status: 53 ongoing. The reasons filed fall into these groups: labeling or instructions for use, software or firmware and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 1
  • 2022 1
  • 2023 4
  • 2024 1
  • 2025 46
  • 2026 0

Showing the 10 most recent of 53 recalls.

  • 2025

    • 10 Jun 2025 Z-0242-2026 Class II Ongoing Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. Distribution: US: CA, IL, and NJ Submission number: K101517
    • 10 Jun 2025 Z-0243-2026 Class II Ongoing Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. Distribution: US: CA, IL, and NJ Submission numbers: K111725, K141895, K191813
    • 10 Jun 2025 Z-0244-2026 Class II Ongoing Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. Distribution: US: CA, IL, and NJ Submission number: K161345
    • 10 Jun 2025 Z-0245-2026 Class II Ongoing Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. Distribution: US: CA, IL, and NJ Submission number: K161345
    • 10 Jun 2025 Z-0246-2026 Class II Ongoing Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. Distribution: US: CA, IL, and NJ Submission number: K161345
    • 10 Jun 2025 Z-0247-2026 Class II Ongoing Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. Distribution: US: CA, IL, and NJ Submission number: K161345
    • 10 Jun 2025 Z-0248-2026 Class II Ongoing Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. Distribution: US: CA, IL, and NJ Submission number: K161345
    • 10 Jun 2025 Z-0249-2026 Class II Ongoing Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. Distribution: US: CA, IL, and NJ Submission number: K161345
    • 10 Jun 2025 Z-0250-2026 Class II Ongoing Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. Distribution: US: CA, IL, and NJ Submission number: K161345
    • 10 Jun 2025 Z-0251-2026 Class II Ongoing Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. Distribution: US: CA, IL, and NJ Submission number: K161345
Show the 25 most recent of 53 recalls

  • 2025

    • 10 Jun 2025 Z-0252-2026 Class II Ongoing Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. Distribution: US: CA, IL, and NJ Submission number: K161345
    • 10 Jun 2025 Z-0253-2026 Class II Ongoing Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. Distribution: US: CA, IL, and NJ Submission number: K090322
    • 10 Jun 2025 Z-0254-2026 Class II Ongoing Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. Distribution: US: CA, IL, and NJ Submission number: K090322
    • 10 Jun 2025 Z-0255-2026 Class II Ongoing Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. Distribution: US: CA, IL, and NJ Submission number: K090322
    • 10 Jun 2025 Z-0256-2026 Class II Ongoing Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. Distribution: US: CA, IL, and NJ Submission number: K090322
    • 10 Jun 2025 Z-0257-2026 Class II Ongoing Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. Distribution: US: CA, IL, and NJ Submission number: K090322
    • 10 Jun 2025 Z-0258-2026 Class II Ongoing Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. Distribution: US: CA, IL, and NJ Submission number: K090322
    • 10 Jun 2025 Z-0259-2026 Class II Ongoing Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. Distribution: US: CA, IL, and NJ Submission number: K090322
    • 10 Jun 2025 Z-0260-2026 Class II Ongoing Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. Distribution: US: CA, IL, and NJ Submission number: K090322
    • 10 Jun 2025 Z-0261-2026 Class II Ongoing Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. Distribution: US: CA, IL, and NJ Submission number: K090322
    • 10 Jun 2025 Z-0262-2026 Class II Ongoing Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. Distribution: US: CA, IL, and NJ Submission number: K090322
    • 10 Jun 2025 Z-0263-2026 Class II Ongoing Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. Distribution: US: CA, IL, and NJ Submission number: K090322
    • 10 Jun 2025 Z-0264-2026 Class II Ongoing Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. Distribution: US: CA, IL, and NJ Submission number: K090322
    • 10 Jun 2025 Z-0265-2026 Class II Ongoing Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. Distribution: US: CA, IL, and NJ Submission number: K090322
    • 10 Jun 2025 Z-0266-2026 Class II Ongoing Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning. Distribution: US: CA, IL, and NJ Submission number: K090322

Frequently asked questions

How many devices does Sedecal., Sa. have in the registry?

The registry currently lists 235 devices for Sedecal., Sa.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Sedecal., Sa.'s devices?

Among its 50 most recently registered devices, Sedecal., Sa. has devices listed in EUDAMED (37 devices), FDA 510(k) (1 device) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Sedecal., Sa.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Sedecal., Sa.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Sedecal., Sa.?

FDA recall records list 53 recalls initiated by Sedecal., Sa., the most recent initiated on 10 Jun 2025. 53 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Sedecal., Sa. in the registry?

The most recently registered devices listed for Sedecal., Sa. include SEDECAL NET 4000-ST, SEDECAL SHFR400, MobileDiagnost wDR 2.2 and SEDECAL SM-40HF-B-D-C.

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