Integrated Medcraft LLC
East Hampton, CT, US
INTEGRATED MEDCRAFT LLC appears in FDA device records in East Hampton, CT. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 2 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 |
|---|---|---|---|---|---|
| 3030078769 | 3030078769 | INTEGRATED MEDCRAFT LLC | 1 Sinco Pl, Unit A10, East Hampton, CT 06424 US | 2026 | and 6 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CAEAirway, Oropharyngeal, Anesthesiology
- KMEBedding, Disposable, Medical
- OFBCatheter Guide Wire Kit
- GBXCatheter, Irrigation
- DXCClamp, Vascular
- FMWCover, Mattress (Medical Purposes)
- FMRDevice, Transfer, Patient, Manual
- LRRFirst Aid Kit With Drug
- OHOFirst Aid Kit Without Drug
- LROGeneral Surgery Tray
- GAANeedle, Aspiration And Injection, Disposable
- FMINeedle, Hypodermic, Single Lumen
- IMDPack, Hot Or Cold, Disposable
- MSHRespirator, Surgical
- PYIThoracic Catheter Insertion Tray
- BTRTube, Tracheal (W/Wo Connector)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2837-2026 | Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035. | Devices could potentially contain an occluded or partially occluded Guedel Airway tip. | Class II | Open, Classified | |
| Z-2836-2026 | FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035. | Devices could potentially contain an occluded or partially occluded Guedel Airway tip. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain