Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in TaiwanLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Galemed Corporation with 7 510(k) clearances and 3 device recalls. The most recent is a device recall dated May 30, 2019: Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only,….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| May 30, 2019 | Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559Class I · Reports of pressure relief manifold venting gas below the standard pressure. | Device recalls |
| May 30, 2019 | Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562Class I · Reports of pressure relief manifold venting gas below the standard pressure. | Device recalls |
| May 30, 2019 | Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802Class I · Reports of pressure relief manifold venting gas below the standard pressure. | Device recalls |
| Apr 18, 2014 | AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTERK132679 · CAH | 510(k) clearances |
| Apr 14, 2014 | DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USEK133957 · BYE | 510(k) clearances |
| Aug 22, 2013 | GIO DIGITAL PRESSURE GUAGESK122627 · CAP | 510(k) clearances |
| Oct 15, 2008 | DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVEK082092 · BTM | 510(k) clearances |
| Nov 16, 2007 | GALEMED CPAP MASKK072755 · BZD | 510(k) clearances |
| Apr 3, 2003 | GALEMED PEAK FLOW METER, MODELS 3751/3752K022124 · BZH | 510(k) clearances |
| Oct 25, 2002 | GALEMED NEB-EASY NEBULIZERK021742 · CAF | 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
