Mercury Medical Enterprises, LLC
Clearwater, FL, US
Mercury Medical Enterprises, LLC appears in FDA device records in Clearwater, FL. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Mercury Medical Enterprises, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Mercury Enterprises, Inc. dba Mercury Medicalenforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1024404 | 1024404 | Mercury Medical Enterprises, LLC | 11300 49th St N, CLEARWATER, FL 33762 US | 2026 | and 11 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CAEAirway, Oropharyngeal, Anesthesiology
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- BXJClip, Nose
- CAHFilter, Bacterial, Breathing-Circuit
- BSJMask, Gas, Anesthetic
- KGBMask, Oxygen, Non-Rebreathing
- BXRMeter, Airway Pressure (Inspiratory Force)
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- BYPMouthpiece, Breathing
- CAFNebulizer (Direct Patient Interface)
- BYIPercussor, Powered-Electric
- BRWProtector, Dental
- NHKResuscitator, Manual, Non Self-Inflating
- BWFSpirometer, Therapeutic (Incentive)
- CCXSupport, Patient Position
- KNTTubes, Gastrointestinal (And Accessories)
- BYXTubing, Pressure And Accessories
- BTMVentilator, Emergency, Manual (Resuscitator)
- BTLVentilator, Emergency, Powered (Resuscitator)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0821-2025 | Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842 | Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and PEEP pressure ranges, which may cause a loss of positive pressure, impacting effective ventilation of the patient. | Class I | Open, Classified | |
| Z-0004-2025 | Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support. | Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step. | Class I | Open, Classified | |
| Z-0639-2016 | Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb). The T-piece resuscitator circuit is a component used in conjunction with the T-piece resuscitator devices | Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain