ICU Medical Healthcare Manufacturing S.A. de C.V.
APODACA Nuevo Leon, MX
ICU Medical Healthcare Manufacturing S.A. de C.V. appears in FDA device records in APODACA Nuevo Leon, MX. FDA records list no 510(k) clearances, no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 2
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 |
|---|---|---|---|---|---|
| 9616567 | 3002963732 | ICU Medical Healthcare Manufacturing S.A. de C.V. | CARRETERA MIGUEL ALEMAN, KM21.7, APODACA Nuevo Leon 66603 MX | 2026 | and 41 more, listed in full below |
| 9617604 | 3002558692 | ICU Medical Healthcare Manufacturing S.A. de C.V. | AVENIDA CALIDAD No 14409, Tijuana, B.C. C.P. Baja California 22424 MX | 2026 | and 48 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- BTQAirway, Nasopharyngeal
- CAEAirway, Oropharyngeal, Anesthesiology
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CAZAnesthesia Conduction Kit
- CBNApparatus, Gas-Scavenging
- CBTArterial Blood Sampling Kit
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- BTCBag, Reservoir
- CCOBed, Rocking, Breathing Assist
- EPEBrush, Cleaning, Tracheal Tube
- CATCannula, Nasal, Oxygen
- BSOCatheter, Conduction, Anesthetic
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- EZLCatheter, Retention Type, Balloon
- BSYCatheters, Suction, Tracheobronchial
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- BYDCondenser, Heat And Moisture (Artificial Nose)
- BZAConnector, Airway (Extension)
- FLLContinuous Measurement Thermometer
- BSKCuff, Tracheal Tube, Inflatable
- FENDevice, Cystometric, Hydraulic
- CBHDevice, Fixation, Tracheal Tube
- CAHFilter, Bacterial, Breathing-Circuit
- BSNFilter, Conduction, Anesthetic
- FPBFilter, Infusion Line
- BSZGas-Machine, Anesthesia
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- DXTInjector And Syringe, Angiographic
- DWSInstruments, Surgical, Cardiovascular
- DYBIntroducer, Catheter
- BSJMask, Gas, Anesthetic
- BYGMask, Oxygen
- DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- BYPMouthpiece, Breathing
- CAFNebulizer (Direct Patient Interface)
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- BWCNeedle, Emergency Airway
- FMINeedle, Hypodermic, Single Lumen
- DPTProbe, Blood-Flow, Extravascular
- FPASet, Administration, Intravascular
- BZOSet, Tubing And Support, Ventilator (W Harness)
- BWFSpirometer, Therapeutic (Incentive)
- FOXStand, Infusion
- BZWStethoscope, Esophageal
- BZTStethoscope, Esophageal, With Electrical Conductors
- FMGStopcock, I.V. Set
- BSRStylet, Tracheal Tube
- DWJSystem, Thermal Regulating
- DRSTransducer, Blood-Pressure, Extravascular
- BTRTube, Tracheal (W/Wo Connector)
- CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
- BTOTube, Tracheostomy (W/Wo Connector)
- FPKTubing, Fluid Delivery
- BYXTubing, Pressure And Accessories
- CBPValve, Non-Rebreathing
- BTMVentilator, Emergency, Manual (Resuscitator)
- BTLVentilator, Emergency, Powered (Resuscitator)
- BSBWarmer, Blood, Non-Electromagnetic Radiation
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain