MICROspecialties LLC
United StatesFDA applicant, unverified FDA FEI 3002616700
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 44 ongoing
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
Catalogue
M2 Compatible Microkeratome Blade Ref K033457
Regimes: 510(k) Registry: 510(k)Keratome Blade, Chirom Model Alk 500500; Keratome Blade, S.C.M.D. Model Turokeratome 400400 Ref K980508
Regimes: 510(k) Registry: 510(k)Keratome Blade (135 Micron, Model 300135), (160 Micron, Model 300160), (200 Micron, Model 30020) Ref K980510
Regimes: 510(k) Registry: 510(k)Keratome Blade 200200 & 600600 Ref K020482
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3002616700
- Address
- 430 Smith St, Middletown, CT, 06457
- Website
- www.microspecialties.com
- [email protected]
- Phone
- +12038741832
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 4
- 2025 0
- 2026 0
2024
- 5 Jun 2024 Z-2333-2024 Class II Ongoing Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
- 5 Jun 2024 Z-2334-2024 Class II Ongoing Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
- 5 Jun 2024 Z-2335-2024 Class II Ongoing Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
- 5 Jun 2024 Z-2336-2024 Class II Ongoing Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
From the company website
MICROspecialties LLC MICROspecialties manufactures single use Ophthalmic blades and specialty ophthalmic products since 1984.
Frequently asked questions
How many devices does MICROspecialties LLC have in the registry?
The registry currently lists 4 devices for MICROspecialties LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list MICROspecialties LLC's devices?
Among its 4 most recently registered devices, MICROspecialties LLC has devices listed in FDA 510(k) (4 devices).
What risk classes do MICROspecialties LLC's devices fall under?
Among its 4 most recently registered devices, the classes recorded for MICROspecialties LLC's devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for MICROspecialties LLC?
FDA recall records list 4 recalls initiated by MICROspecialties LLC, the most recent initiated on 5 Jun 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 MICROspecialties LLC in the registry?
The most recently registered devices listed for MICROspecialties LLC include M2 COMPATIBLE MICROKERATOME BLADE, KERATOME BLADE, CHIROM MODEL ALK 500500; KERATOME BLADE, S.C.M.D. MODEL TUROKERATOME 400400, KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020) and KERATOME BLADE 200200 & 600600.