FDA applicant

Fresenius Medical Care South Asia Pacific Pty, Ltd.

Milsons Point,, AU2 decisions2009–20110 recalls

FDA records 2 decisions for Fresenius Medical Care South Asia Pacific Pty, Ltd. (Milsons Point,, AU) from 2009 to 2011: 2 510(k) clearances. All are in product code INO (Chair, Positioning, Electric). 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, physical medicine panel, where it files most

How often FDA has decided Fresenius Medical Care South Asia Pacific Pty, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Fresenius Medical Care South Asia Pacific Pty, Ltd. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fresenius Medical Care South Asia…’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 “Fresenius”

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

Fresenius Medical Care Renal Therapies Group, LLC 53 Fresenius Medical Care North America 43 Fresenius USA, Inc. 38 Fresenius Kabi AG 14 Fresenius Medical Care 7 Fresenius Medical Care North America, Design Cente 5 Fresenius Hemotechnology, Inc. 3 Fresenius Pharma 3 Fresenius AG 2 Fresenius Kabi USA,Llc 2 Fresenius/Delmed, Inc. 2 Fresenius Hemocare, Inc. 1

Fresenius Medical Care South Asia Pacific Pty, Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Fresenius”