Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled 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 15, 2026, FDA's public records list Mercury Medical and its 3 subsidiaries with 21 510(k) clearances and 3 device recalls. The most recent is a device recall dated Dec 10, 2024: Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Mercury Medical and its 3 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 10, 2024 | Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 10508Class I · Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause | Device recalls |
| Aug 30, 2024 | Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.Class I · Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step. | Device recalls |
| Oct 22, 2015 | Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator Class II · Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent failure t | Device recalls |
| Oct 17, 2014 | T-PIECE RESUSCITATORK142096 · BTL | 510(k) clearances |
| Apr 6, 2010 | MERCURY MEDICAL T-PIECE RESUSCITATORK093913 · BTL | 510(k) clearances |
| Aug 20, 2009 | MERCURY CPAPK090710 · BYE | 510(k) clearances |
| Mar 5, 2009 | MERCURY MEDICAL PEEP VALVEK081266 · BYE | 510(k) clearances |
| Feb 23, 2009 | NEO-STAT CO2 <KGK083056 · CCK | 510(k) clearances |
| Feb 3, 2004 | MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETERK032593 · BXR | 510(k) clearances |
| Aug 14, 2003 | STATCO2METER, MODEL 10-55372K031814 · CCK | 510(k) clearances |
| Jul 30, 2003 | MINI STATCO2 CO2 DETECTOR, MODEL 10-55371K031411 · CCK | 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
