Carwild Corp.
New London, CT, US
CARWILD CORP. appears in FDA device records in New London, CT. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Carwild Corp. between 1979 and 1992. The busiest year on record is 1979, with 3. The most recent is 1992, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 3 |
| 1984 | 1 |
| 1992 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K913303 | LAP SPONGES, MODIFIED | GDY | Substantially Equivalent | |
| K913302 | DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED | GDY | Substantially Equivalent | |
| K833688 | SUTURE REMOVAL KITS STERILE | KGX | Substantially Equivalent | |
| K791872 | LAP SPONGES | EFQ | Substantially Equivalent | |
| K791871 | NEUROLOGICAL SPONGES (PATTIES) | EFQ | Substantially Equivalent | |
| K791870 | DISPOSABLE SPECIALITY SPONGES | GDI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1219313 | 1219313 | CARWILD CORP. | 3 State Pier Rd, NEW LONDON, CT 06320 US | 2026 | and 22 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- PUKAdministration Set Securement Device
- KXGApplicator, Absorbent Tipped, Sterile
- EMXBalloon, Epistaxis
- EFNCotton, Roll
- FMADepressor, Tongue, Non-Surgical
- CBHDevice, Fixation, Tracheal Tube
- KMKDevice, Intravascular Catheter Securement
- KYGDevice, Irrigation, Ocular Surgery
- GDIDissector, Surgical, General & Plastic Surgery
- MGPDressing, Wound And Burn, Occlusive
- NACDressing, Wound, Hydrophilic
- KCNEar Wick
- FRLFiber, Medical, Absorbent
- JESFloss, Dental
- NABGauze / Sponge,Nonresorbable For External Use
- EFQGauze/Sponge, Internal
- GDYGauze/Sponge, Internal, X-Ray Detectable
- QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics
- EGZHolder, Film, X-Ray
- EYJHolder, Ureteral Catheter
- MDMInstrument, Manual, Surgical, General Use
- EMFKnife, Surgical
- KYBLens, Guide, Intraocular
- HBANeurosurgical Paddie
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- ILISling, Arm
- FYHSplint, Extremity, Noninflatable, External, Sterile
- HOZSponge, Ophthalmic
- MIHSystem, Endovascular Graft, Aortic Aneurysm Treatment
- KGXTape And Bandage, Adhesive
- PODTemporary, Internal Use Hemostatic
- BZDVentilator, Non-Continuous (Respirator)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0800-2025 | Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q770410 | Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product. | Class II | Open, Classified | |
| Z-0799-2025 | Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237 | Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product. | Class II | Open, Classified | |
| Z-0798-2025 | Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site. Model Number: Q604206 | Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product. | Class II | Open, Classified | |
| Z-1747-2022 | FABCO 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: 34911510 | Sterility with new cotton source not validated | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain