Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in NorwayLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Laerdal Medical and its 2 subsidiaries with 30 510(k) clearances and 4 device recalls. The most recent is a 510(k) clearance dated Nov 24, 2025: The BAG manual resuscitator and accessories.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Laerdal Medical and its 2 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Nov 24, 2025 | The BAG manual resuscitator and accessoriesK251631 · BTM | 510(k) clearances |
| Jun 25, 2024 | NeoBeat, NeoBeat MiniK232111 · MWI | 510(k) clearances |
| Dec 18, 2020 | Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for Class II · Component failures may cause the unit to lose all suction. Users will need to obtain alternate suction devices or method | Device recalls |
| Dec 17, 2018 | Reusable Silicone Cover CPRmeter 2K183348 · LIX | 510(k) clearances |
| Mar 23, 2018 | CPRmeter 2 CPR Feedback DeviceK173886 · LIX | 510(k) clearances |
| Aug 13, 2015 | Reusable Full Silicone CoverK151702 · LIX | 510(k) clearances |
| Jan 15, 2015 | NEONATALIE RESUSCITATORK132172 · BTM | 510(k) clearances |
| Oct 22, 2012 | CPRMETER CPR FEEDBACK DEVICEK122050 · LIX | 510(k) clearances |
| Feb 11, 2003 | LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050K023805 · CBP | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
