Data / Medical devices / United States / Integrated Medcraft LLC
Integrated Medcraft LLC: FDA-registered device maker in East Hampton, CT, United States, 4 510(k) clearances
Integrated Medcraft LLC is registered with the FDA (registration 3030078769) in East Hampton, CT, United States. It lists 16 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 3, 2023. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030078769
- Address
- 1 Sinco Pl, Unit A10, East Hampton, CT, United States, 06424
- Owner or operator
- Integrated Medcraft LLC (10089406)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- January 16, 2024
- Registered through
- 2026
- Brand names listed
- APLS Emergency Blanket, APLS Gurney Guard, APLS Life Guard, APLS Litter Guard, APLS Surgical Soaker, APLS Thermal Guard, APLS Thermal Guard Mylar, APLS Thermal Wrap and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 3, 2023 | K221661 | Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) | DXC | Substantially Equivalent | Compression Works, Inc. | accessdata.fda.gov |
| November 21, 2019 | K191488 | SAM IO Intraosseous Access System | FMI | Substantially Equivalent | Sam® Medical Products, Inc. | accessdata.fda.gov |
| February 23, 2007 | K063023 | 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870 | MSH | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| June 27, 1996 | K955495 | RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE | BTR | Substantially Equivalent | Rusch, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 25, 2026 | 99948 | Class II | Ongoing | FORWARD Gunshot Wound Kit; Model: AFT-GSW | Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the sterile pad to degrade over time. The degradation may cause remnants of the nonwoven pad material to dislodge on the wound or in close proximity to the wound. | accessdata.fda.gov |
| July 7, 2026 | 99295 | Class II | Ongoing | 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, lig | Devices could potentially contain an occluded or partially occluded Guedel Airway tip. | accessdata.fda.gov |
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Updated October 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.