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Data / Medical devices / United States / Carwild Corp.

Carwild Corp.: FDA-registered device maker in New London, CT, United States, 4 510(k) clearances

Carwild Corp. is registered with the FDA (registration 1219313) in New London, CT, United States. It lists 32 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 21, 1999. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Carwild Corp.
FDA registration number
1219313
Address
3 State Pier Rd, New London, CT, United States, 06320
Owner or operator
CARWILD CORPORATION (1219313)
Roles
Contract manufacturer, Manufacturer, Specification developer
First device listed
August 17, 1979
Registered through
2026
Brand names listed
BVI, CHAMPION, DALE MEDICAL PRODUCTS, ENDOSTIK, FABCO, Flex-O-Blade, GENESIS, HYDRASORB and more

Devices it lists

DeviceProduct codeClassRoleSource
Administration Set Securement DevicePUK1Contract manufactureraccessdata.fda.gov
Applicator, Absorbent Tipped, SterileKXG1Specification developeraccessdata.fda.gov
Balloon, EpistaxisEMX1Contract manufacturer, Specification developeraccessdata.fda.gov
Cotton, RollEFN1Contract manufacturer, Specification developeraccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Specification developeraccessdata.fda.gov
Device, Fixation, Tracheal TubeCBH1Contract manufactureraccessdata.fda.gov
Device, Intravascular Catheter SecurementKMK1Contract manufactureraccessdata.fda.gov
Device, Irrigation, Ocular SurgeryKYG1Contract manufactureraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Dressing, Wound And Burn, OcclusiveMGPUContract manufacturer, Manufactureraccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Contract manufacturer, Manufactureraccessdata.fda.gov
Ear WickKCN1Contract manufacturer, Specification developeraccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Specification developeraccessdata.fda.gov
Floss, DentalJES1Contract manufacturer, Specification developeraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Contract manufactureraccessdata.fda.gov
Gauze/Sponge, InternalEFQUSpecification developeraccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Contract manufacturer, Specification developeraccessdata.fda.gov
Hemostatic Wound Dressing Without Thrombin Or Other BiologicsQSYUContract manufactureraccessdata.fda.gov
Holder, Film, X-RayEGZ1Contract manufactureraccessdata.fda.gov
Holder, Ureteral CatheterEYJ1Contract manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Contract manufacturer, Specification developeraccessdata.fda.gov
Knife, SurgicalEMF1Contract manufactureraccessdata.fda.gov
Lens, Guide, IntraocularKYB1Contract manufactureraccessdata.fda.gov
Neurosurgical PaddieHBA2Contract manufactureraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Contract manufactureraccessdata.fda.gov
Sling, ArmILI1Specification developeraccessdata.fda.gov
Splint, Extremity, Noninflatable, External, SterileFYH1Contract manufactureraccessdata.fda.gov
Sponge, OphthalmicHOZ2Contract manufacturer, Specification developeraccessdata.fda.gov
System, Endovascular Graft, Aortic Aneurysm TreatmentMIH3Contract manufactureraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Contract manufactureraccessdata.fda.gov
Temporary, Internal Use HemostaticPOD2Contract manufactureraccessdata.fda.gov
Ventilator, Non-Continuous (Respirator)BZD2Contract manufactureraccessdata.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
December 21, 1999K993883M-PACT CORNEAL LIGHT SHIELDHOZSubstantially EquivalentM-Pact Corp.accessdata.fda.gov
October 21, 1997K973260HYDRASORB STERILE DRESSINGMGPSubstantially EquivalentAvitar, Inc.accessdata.fda.gov
July 31, 1997K971832IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICKHOZSubstantially EquivalentM-Pact Worldwide Management Corp.accessdata.fda.gov
November 5, 1979K791871NEUROLOGICAL SPONGES (PATTIES)EFQSubstantially EquivalentCarwild Corp.accessdata.fda.gov

Recalls

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

InitiatedEventClassStatusProductReasonSource
October 22, 202495909Class IIOngoingIvalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site. Model Number: Q604206Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.accessdata.fda.gov
August 2, 202290808Class IIOngoingFABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50 Pouches/Box Reorder Number: 34911510Sterility with new cotton source not validatedaccessdata.fda.gov

Compare with other makers

Updated January 2, 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.