Carwild Corp.
United StatesFDA applicant, unverified FDA FEI 1219313
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 44 ongoing
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
Catalogue
Suture Removal Kits Sterile Ref K833688
Regimes: 510(k) Registry: 510(k)Lap Sponges Ref K791872
Regimes: 510(k) Registry: 510(k)Neurological Sponges (Patties) Ref K791871
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Disposable Speciality Sponges Ref K791870
Regimes: 510(k) Registry: 510(k)Lap Sponges, Modified Ref K913303
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 1219313
- Address
- 3 State Pier Rd, NEW LONDON, CT, 06320
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 1
- 2023 0
- 2024 3
- 2025 0
- 2026 0
2024
- 22 Oct 2024 Z-0798-2025 Class II Ongoing Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
- 22 Oct 2024 Z-0799-2025 Class II Ongoing Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
- 22 Oct 2024 Z-0800-2025 Class II Ongoing Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
2022
- 2 Aug 2022 Z-1747-2022 Class II Ongoing Sterility with new cotton source not validated
Frequently asked questions
How many devices does Carwild Corp. have in the registry?
The registry currently lists 6 devices for Carwild Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Carwild Corp.'s devices?
Among its 6 most recently registered devices, Carwild Corp. has devices listed in FDA 510(k) (6 devices).
What risk classes do Carwild Corp.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Carwild Corp.'s devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Carwild Corp.?
FDA recall records list 4 recalls initiated by Carwild Corp., the most recent initiated on 22 Oct 2024. 4 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Carwild Corp. in the registry?
The most recently registered devices listed for Carwild Corp. include SUTURE REMOVAL KITS STERILE, LAP SPONGES, NEUROLOGICAL SPONGES (PATTIES) and DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED.