FDA applicant

Primed Halberstadt Medizintechnik GmbH

Halberstadt, DE1 decision2012–20120 recalls

FDA records 1 decision for Primed Halberstadt Medizintechnik GmbH (Halberstadt, DE) in 2012: 1 510(k) clearance. All are in product code BTO (Tube, Tracheostomy (W/Wo Connector)). Its devices cite 7 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Primed Halberstadt Medizintechnik GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Primed Halberstadt Medizintechnik GmbH by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Primed Halberstadt Medizintechnik GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Primed”

FDA records each applicant name separately; these may or may not be the same firm.

Primed Medical Products, Inc. 10 Primed Instruments, Inc. 1 Primed Products, Inc. 1 Primed, Inc. 1

Primed Halberstadt Medizintechnik GmbH

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Primed”