FDA applicant

Carmel Pharma Ab.

Gothenburg, SE7 decisions1998–20114 recalls

FDA records 7 decisions for Carmel Pharma Ab. (Gothenburg, SE) from 1998 to 2011: 7 510(k) clearances. All are in product code LHI (Set, I.V. Fluid Transfer). Its devices cite 8 predicates, 6 of them its own earlier devices. 4 recalls are linked to its devices.

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

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Carmel Pharma Ab.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

4in 2007

2007high 4 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Carmel Pharma Ab. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Carmel”

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

Carmel Medical Devices 1

Carmel Pharma Ab.

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?

What has been recalled?

Other applicant names beginning “Carmel”