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Data / Medical devices / United States / Rece International Corp.

Rece International Corp.: FDA-registered device maker in Miami, FL, United States, 11 510(k) clearances

Rece International Corp. is registered with the FDA (registration 3003965134) in Miami, FL, United States. It lists 116 device types. The FDA files 11 510(k) clearances under its listings, the newest dated July 3, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Rece International Corp.
FDA registration number
3003965134
Address
4696 Nw 74th Ave, Miami, FL, United States, 33166
Owner or operator
RECE INTERNATIONAL CORP. (9071876)
Roles
Repackager or relabeler
First device listed
February 23, 2006
Registered through
2026
Brand names listed
ALCOHOL SWABS STICKS, Adhesive Ostomy Pouch and Access, COLD WATER BOTTLE, ES, Rece International Corp, SPONGE, VIAMED ALCOHOL PREP PADS, VIAMED BALLOON TYPE CATHETER and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Repackager or relabeleraccessdata.fda.gov
Adaptor, Ureteral CatheterEYI1Repackager or relabeleraccessdata.fda.gov
Anoscope And AccessoriesFER2Repackager or relabeleraccessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, NonpoweredGCY1Repackager or relabeleraccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Repackager or relabeleraccessdata.fda.gov
Applicator, Absorbent Tipped, SterileKXG1Repackager or relabeleraccessdata.fda.gov
Applicator, EntKCJ1Repackager or relabeleraccessdata.fda.gov
Apron, ProtectiveIWO1Repackager or relabeleraccessdata.fda.gov
Bag, Drainage, With Adhesive, OstomyFON1Repackager or relabeleraccessdata.fda.gov
Bag, IceKYR1Repackager or relabeleraccessdata.fda.gov
Bag, Urine Collecting, UreterostomyEXG1Repackager or relabeleraccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, Non-SterileNNW1Repackager or relabeleraccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, SterileFAQ1Repackager or relabeleraccessdata.fda.gov
Bandage, CastITG1Repackager or relabeleraccessdata.fda.gov
Bandage, ElasticFQM1Repackager or relabeleraccessdata.fda.gov
Basin, EmesisFNY1Repackager or relabeleraccessdata.fda.gov
Beads, Hydrophilic, For Wound Exudate AbsorptionKOZ1Repackager or relabeleraccessdata.fda.gov
BedpanFOB1Repackager or relabeleraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Repackager or relabeleraccessdata.fda.gov
Blade, Saw, Surgical, CardiovascularDWH1Repackager or relabeleraccessdata.fda.gov
Blade, ScalpelGES1Repackager or relabeleraccessdata.fda.gov
Blood Pressure CuffDXQ2Repackager or relabeleraccessdata.fda.gov
Bottle, Hot/Cold WaterFPF1Repackager or relabeleraccessdata.fda.gov
Bottle, Roller, Tissue CultureKJC1Repackager or relabeleraccessdata.fda.gov
Brush, Biopsy, General & Plastic SurgeryGEE1Repackager or relabeleraccessdata.fda.gov
Brush, Cleaning, Tracheal TubeEPE1Repackager or relabeleraccessdata.fda.gov
Brush, Scrub, Operating-RoomGEC1Repackager or relabeleraccessdata.fda.gov
Cannula, InjectionFGY1Repackager or relabeleraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Repackager or relabeleraccessdata.fda.gov
Cap, SurgicalFYF1Repackager or relabeleraccessdata.fda.gov
Catheter, Balloon TypeGBA1Repackager or relabeleraccessdata.fda.gov
Catheter, Continuous IrrigationGBQ1Repackager or relabeleraccessdata.fda.gov
Catheter, InfusionJCY1Repackager or relabeleraccessdata.fda.gov
Catheter, Multiple LumenGBP1Repackager or relabeleraccessdata.fda.gov
Catheter, Nasal, OxygenBZB1Repackager or relabeleraccessdata.fda.gov
Catheter, Nephrostomy, General & Plastic SurgeryGBO1Repackager or relabeleraccessdata.fda.gov
Catheter, PeritonealGBW1Repackager or relabeleraccessdata.fda.gov
Catheter, Rectal For Continent IleostomyKPH1Repackager or relabeleraccessdata.fda.gov
Catheter, Retention Type, BalloonEZL2Repackager or relabeleraccessdata.fda.gov
Catheter, Ventricular, General & Plastic SurgeryGBS1Repackager or relabeleraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Repackager or relabeleraccessdata.fda.gov
Centrifuges (Micro, Ultra, Refrigerated) For Clinical UseJQC1Repackager or relabeleraccessdata.fda.gov
Component, CastLGF1Repackager or relabeleraccessdata.fda.gov
Container, SharpsMMK2Repackager or relabeleraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Repackager or relabeleraccessdata.fda.gov
Container, Specimen, SterileFMH1Repackager or relabeleraccessdata.fda.gov
Container, Specimen, Urine, Drugs Of Abuse, Over The CounterMPQ1Repackager or relabeleraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Repackager or relabeleraccessdata.fda.gov
Cotton, RollEFN1Repackager or relabeleraccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Repackager or relabeleraccessdata.fda.gov
Coverslips, Microscope SlideKES1Repackager or relabeleraccessdata.fda.gov
Cup, ProphylaxisEHK1Repackager or relabeleraccessdata.fda.gov
Cushion, FlotationKIC1Repackager or relabeleraccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Repackager or relabeleraccessdata.fda.gov
Device, Fixation, Tracheal TubeCBH1Repackager or relabeleraccessdata.fda.gov
Device, Incontinence, Urosheath Type, Non-SterileNNX1Repackager or relabeleraccessdata.fda.gov
Device, Incontinence, Urosheath Type, SterileEXJ1Repackager or relabeleraccessdata.fda.gov
Device, Occlusion, UmbilicalFOD1Repackager or relabeleraccessdata.fda.gov
Dilator, Cervical, Fixed SizeHDQ1Repackager or relabeleraccessdata.fda.gov
Dish, Tissue CultureKIZ1Repackager or relabeleraccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Repackager or relabeleraccessdata.fda.gov
Dispenser, Liquid MedicationKYX1Repackager or relabeleraccessdata.fda.gov
Douche Apparatus, Vaginal, TherapeuticHED1Repackager or relabeleraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Repackager or relabeleraccessdata.fda.gov
Dress, SurgicalFYE1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Repackager or relabeleraccessdata.fda.gov
Electrode, ElectrocardiographDRX2Repackager or relabeleraccessdata.fda.gov
Epilator, High Frequency, Tweezer-TypeKCX1Repackager or relabeleraccessdata.fda.gov
Excavator, EarJYH1Repackager or relabeleraccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Repackager or relabeleraccessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific ConnectorsPIF2Repackager or relabeleraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Repackager or relabeleraccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Repackager or relabeleraccessdata.fda.gov
Gown, ExaminationFME1Repackager or relabeleraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Repackager or relabeleraccessdata.fda.gov
Holder, Ureteral CatheterEYJ1Repackager or relabeleraccessdata.fda.gov
Ligator, HemorrhoidalFHN2Repackager or relabeleraccessdata.fda.gov
Mask, OxygenBYG1Repackager or relabeleraccessdata.fda.gov
Mask, Oxygen, Low Concentration, VenturiBYF1Repackager or relabeleraccessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)CCQ1Repackager or relabeleraccessdata.fda.gov
Non-Surgical GownOEA1Repackager or relabeleraccessdata.fda.gov
OximeterDQA2Repackager or relabeleraccessdata.fda.gov
Pouch, ColostomyEZQ1Repackager or relabeleraccessdata.fda.gov
Pump, Breast, Non-PoweredHGY1Repackager or relabeleraccessdata.fda.gov
Scissors, UmbilicalHDJ1Repackager or relabeleraccessdata.fda.gov
Set, I.V. Fluid TransferLHI2Repackager or relabeleraccessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)BZO1Repackager or relabeleraccessdata.fda.gov
Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-SterileNNY1Repackager or relabeleraccessdata.fda.gov
Sheath, Corrugated Rubber, For Nonindwelling Catheter, SterileEYT1Repackager or relabeleraccessdata.fda.gov
Shield, Protective, PersonnelKPY1Repackager or relabeleraccessdata.fda.gov
Shoe And Shoe Cover, ConductiveBWP1Repackager or relabeleraccessdata.fda.gov
Shoes, Operating-RoomFXW1Repackager or relabeleraccessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureFMK2Repackager or relabeleraccessdata.fda.gov
Spatula, Cervical, CytologicalHHT2Repackager or relabeleraccessdata.fda.gov
Speculum, Vaginal, NonmetalHIB2Repackager or relabeleraccessdata.fda.gov
Splint, Hand, And ComponentsILH1Repackager or relabeleraccessdata.fda.gov
Stethoscope, ManualLDE1Repackager or relabeleraccessdata.fda.gov
Stocking, ElasticILG1Repackager or relabeleraccessdata.fda.gov
Stocking, Medical Support (For General Medical Purposes)FQL1Repackager or relabeleraccessdata.fda.gov
Strip, Temperature, Forehead, Liquid CrystalKPD2Repackager or relabeleraccessdata.fda.gov
Stylet, Tracheal TubeBSR1Repackager or relabeleraccessdata.fda.gov
Suit, SurgicalFXO1Repackager or relabeleraccessdata.fda.gov
Surgical Instruments, G-U, Manual (And Accessories)KOA1Repackager or relabeleraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Repackager or relabeleraccessdata.fda.gov
System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-SterileNNZ1Repackager or relabeleraccessdata.fda.gov
System, Urine Drainage, Closed, For Nonindwelling Catheter, SterileEYZ1Repackager or relabeleraccessdata.fda.gov
Thermometer, Clinical MercuryFLK2Repackager or relabeleraccessdata.fda.gov
Topical Approximation SystemMZR1Repackager or relabeleraccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Repackager or relabeleraccessdata.fda.gov
Trap, Sterile SpecimenBYZ2Repackager or relabeleraccessdata.fda.gov
Tube, Ear SuctionJZF1Repackager or relabeleraccessdata.fda.gov
Tube, Tissue CultureKJG1Repackager or relabeleraccessdata.fda.gov
Tube, Tonsil SuctionKCB1Repackager or relabeleraccessdata.fda.gov
UrinalFNP1Repackager or relabeleraccessdata.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 3, 2024K240052Disposable Enteral Feeding SetsPIFSubstantially EquivalentBeijing L&Z Medical Technology Development Co., Ltd.accessdata.fda.gov
December 22, 2023K230439WellCare AnoscopeFERSubstantially EquivalentWell Care (Wuhan) Medical Technology Co., Ltd.accessdata.fda.gov
May 22, 2019K190902RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with StethoscopeDXQSubstantially EquivalentWenzhou Renhua Instruments Co., Ltd.accessdata.fda.gov
July 11, 2012K120424MEDSOURCE IV ADMINSTRATION SETLHISubstantially EquivalentMedsource International, LLCaccessdata.fda.gov
January 7, 2010K092447DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIESFLLSubstantially EquivalentHangzhou Hua'An Medical & Health Instruments Co.,accessdata.fda.gov
November 10, 2008K082641FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DLDQASubstantially EquivalentContec Medical System Co., Ltd.accessdata.fda.gov
October 8, 2008K082815WELL LEAD SILICONE AND LATEX FOLEY CATHETERSEZLSubstantially EquivalentWell Lead Medical Instrumentsaccessdata.fda.gov
September 3, 2008K082042GONGDONG DISPOSABLE SHARP CONTAINERMMKSubstantially EquivalentZhejiang Gongdong Medical Plastic Factoryaccessdata.fda.gov
July 11, 2005K050887GONGDONG DISPOSABLE VAGINAL SPECULUMHIBSubstantially EquivalentZhejiang Gongdong Medical Plastic Factoryaccessdata.fda.gov
September 15, 2004K041954DISPOSABLE MONITORING ELECTRODESDRXSubstantially EquivalentShanghai Intco Electrode Manufacturing Co., Ltd.accessdata.fda.gov
July 25, 1995K950780AMSINO CERVICAL SCRAPERHHTSubstantially EquivalentAmsino Intl., Inc.accessdata.fda.gov

Compare with other makers

Updated July 3, 2024. 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.