Microspecialties LLC
Middletown, CT, US
Microspecialties LLC appears in FDA device records in Middletown, CT. FDA records list no 510(k) clearances, 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
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1226074 | 3002616700 | Microspecialties LLC | 430 Smith St, Middletown, CT 06457 US | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- MOECollagen Corneal Shield
- HMTDrape, Patient, Ophthalmic
- OJKEye Tray
- HNOKeratome, Ac-Powered
- KDDKit, Surgical Instrument, Disposable
- HNNKnife, Ophthalmic
- HMRMarker, Ocular
- JDWPin, Fixation, Threaded
- LZUPlug, Punctum
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- HOZSponge, Ophthalmic
- PZGSurgical Eye Tray
- GAZTubing, Noninvasive
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2336-2024 | Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection Model/Catalog Number: 18069W | Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection. | Class II | Open, Classified | |
| Z-2335-2024 | Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Model/Catalog Number: 18069 Product Description: | Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection. | Class II | Open, Classified | |
| Z-2334-2024 | Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections Model/Catalog Number: 18061 | Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection. | Class II | Open, Classified | |
| Z-2333-2024 | Synergetics I Pack Injection Kit- Tray for use with Ophthalmic injections Model/Catalog Number: 18060 | Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain