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Data / Medical devices / Dominican Republic / CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG

CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG: FDA-registered device maker in HAINA San Cristobal, Dominican Republic, 28 510(k) clearances

CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG is registered with the FDA (registration 9615817) in HAINA San Cristobal, Dominican Republic. It lists 23 device types. The FDA files 28 510(k) clearances under its listings, the newest dated July 23, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG
FDA registration number
9615817
FEI number
3003081151
Address
Parque Industrial Itabo KM. 18.5 Carr. Sanchez, HAINA San Cristobal, Dominican Republic, --
Owner or operator
Becton, Dickinson and Company (10093301)
Roles
Manufacturer
First device listed
April 26, 2025
Registered through
2026
Brand names listed
Accumen IQ finger cuff, Acumen AFM Cable, Acumen AFM cable - HemoSphere Alta monitor, Acumen IQ Fluid Meter, Acumen IQ Plus Finger Cuff, Acumen IQ Sensor, Acumen IQ finger cuff, Acumen IQ finger cuff adult and more

Devices it lists

DeviceProduct codeClassRoleSource
Adjunctive Open Loop Fluid Therapy RecommenderQMS2Manufactureraccessdata.fda.gov
Adjunctive Predictive Cardiovascular IndicatorQAQ2Manufactureraccessdata.fda.gov
Catheter, Continuous FlushKRA2Manufactureraccessdata.fda.gov
Catheter, EmbolectomyDXE2Manufactureraccessdata.fda.gov
Catheter, Flow DirectedDYG2Manufactureraccessdata.fda.gov
Catheter, Intravascular, DiagnosticDQO2Manufactureraccessdata.fda.gov
Catheter, Oximeter, Fiber-OpticDQE2Manufactureraccessdata.fda.gov
Cerebral OximeterQEM2Manufactureraccessdata.fda.gov
Clamp, Surgical, General & Plastic SurgeryGDJ1Manufactureraccessdata.fda.gov
Clamp, VascularDXC2Manufactureraccessdata.fda.gov
Computer, Diagnostic, Pre-Programmed, Single-FunctionDXG2Manufactureraccessdata.fda.gov
Computer, Diagnostic, ProgrammableDQK2Manufactureraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Manufactureraccessdata.fda.gov
Medium-Term Adjunctive Predictive Cardiovascular IndicatorQNL2Manufactureraccessdata.fda.gov
Oximeter, Tissue SaturationMUD2Manufactureraccessdata.fda.gov
Plethysmograph, ImpedanceDSB2Manufactureraccessdata.fda.gov
Probe, ThermodilutionKRB2Manufactureraccessdata.fda.gov
Set, Administration, IntravascularFPA2Manufactureraccessdata.fda.gov
Stand, InfusionFOX1Manufactureraccessdata.fda.gov
Stopcock, I.V. SetFMG2Manufactureraccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Manufactureraccessdata.fda.gov
Transducer, Blood-Pressure, ExtravascularDRS2Manufactureraccessdata.fda.gov
Transducer, Pressure, Catheter TipDXO2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 23, 2025K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2)DQKSubstantially EquivalentEdwards Lifesciencesaccessdata.fda.gov
March 21, 2025K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsDRSSubstantially EquivalentEdwards Lifesciences, LLCaccessdata.fda.gov
December 9, 2024K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)DYGSubstantially EquivalentEdwards Lifesciencesaccessdata.fda.gov
June 6, 2024K233824Swan-Ganz catheterDYGSubstantially EquivalentEdwards Lifesciences, LLCaccessdata.fda.gov
October 24, 2023K230919Acumen IQ finger cuffDXNSubstantially EquivalentEdwards Lifesciences, LLCaccessdata.fda.gov
September 21, 2023K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring PlatformDYGSubstantially EquivalentEdwards Lifesciencess, LLCaccessdata.fda.gov
June 9, 2023K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference SensorDQKSubstantially EquivalentEdwards Lifesciences, LLCaccessdata.fda.gov
December 22, 2022K222216TruWave Disposable Pressure TransducerDXOSubstantially EquivalentEdwards Lifesciences, LLCaccessdata.fda.gov
June 21, 2019K190130The ClearSight finger cuffsDXNSubstantially EquivalentEdwards Lifesciences, LLCaccessdata.fda.gov
May 1, 2019K183413TruWave Disposable Pressure TransducerDXOSubstantially EquivalentEdwards Lifeciences, LLCaccessdata.fda.gov
November 30, 2018K182245EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight SystemDXNSubstantially EquivalentEdwards Lifesciences, LLCaccessdata.fda.gov
November 8, 2018K181684VAMP Plus Venous/Arterial Blood Management Protection SystemKRASubstantially EquivalentEdwards Lifesciences, LLCaccessdata.fda.gov
October 24, 2018K180275VAMP Optima closed blood sampling systemKRASubstantially EquivalentEdwards Lifesciences, LLCaccessdata.fda.gov
April 5, 2018K173586VAMP Venous/Arterial Blood Management Protection SystemKRASubstantially EquivalentEdwards Lifesciences, LLCaccessdata.fda.gov
October 23, 2017K171996TruWave Disposable Pressure TransducerDXOSubstantially EquivalentEdwards Lifesciences, LLCaccessdata.fda.gov
November 28, 2016K161962VAMP Venous/Arterial Blood Management Protection SystemKRASubstantially EquivalentEdwards Lifesciences, LLCaccessdata.fda.gov
June 1, 2016K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical PlatformDXNSubstantially EquivalentEdwards Lifesciences, LLCaccessdata.fda.gov
May 3, 2016K160084Swan Ganz CathetersDYGSubstantially EquivalentEdwards Lifesciences, LLCaccessdata.fda.gov
January 19, 2016K152980Flo Trac sensor, Volume View sensorDRSSubstantially EquivalentEdwards Lifesciences, LLCaccessdata.fda.gov
April 10, 2015K143675FORE-SIGHT Elite Absolute Tissue OximeterMUDSubstantially EquivalentCas Medical Systems, Inc.accessdata.fda.gov
January 18, 2015K142749TruWave Disposable Pressure TransducerDXOSubstantially EquivalentEdwards Lifesciences, LLCaccessdata.fda.gov
September 3, 2014K141495TRUWAVE DISPOSABLE PRESSURE TRANSDUCERDXOSubstantially EquivalentEdwards Lifesciences, LLCaccessdata.fda.gov
October 18, 1993K925638PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600DXOSubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
January 19, 1990K896819VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTIONKRASubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
September 29, 1983K832554FOGARTY 6MM SOFTJAW CLIPDXCSubstantially EquivalentAmerican Edwards Laboratoriesaccessdata.fda.gov
July 2, 1982K821416DISPOSABLE BLOOD PRESSURE TRANSDUCERDRSSubstantially EquivalentBentley Laboratories, Inc.accessdata.fda.gov
June 9, 1981K811399EDSLAB CLOSED INJECTATE DELIVERY SYSTEMKRBSubstantially EquivalentAmerican Edwards Laboratoriesaccessdata.fda.gov
February 4, 1981K810162FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06DXCSubstantially EquivalentAmerican Edwards Laboratoriesaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
March 14, 200852802Not yet classifiedTerminatedEdwards Lifesciences "VAMP Jr" (Venous Arterial blood Management Protection system), Lot numbers (all product manufactured between 8/01/06 and 2/29/08.)Edwards Lifescience initiated a recall of on Edwards "VAMP Jr" Pressure Monitoring Products manufactured between 8/01/06 and 2/29/08 due to the potential for the cap on the reservoir of the "VAMP Jr" to become disconnected.accessdata.fda.gov
November 20, 200327871Not yet classifiedTerminatedVAMP Direct Draw, Model VMP700 Needleless cannula for sampling blood.Seal integrity, sterility not assured.accessdata.fda.gov

Compare with other makers

Updated July 23, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.