Customed
Medical device makerAI. FDA records under 3 spellings of its name, each linked to the record.
- Device recalls: 682
- 510(k) clearances: 37
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Jun 3, 2026 | CustoMED ViewerK260116 · LLZ | 510(k) clearances |
| Jan 7, 2016 | Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL Used by medical staff to perform surgical procedures and patient care procedures suchClass II · Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for produc | Device recalls |
| Jan 7, 2016 | Catalog Number: 9002615 EXTREMITY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such asClass II · Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for produc | Device recalls |
| Jan 7, 2016 | Catalog Number: 9001482 ENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wounClass II · Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for produc | Device recalls |
| Jan 7, 2016 | Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT Used by medical staff to perform surgical procedures and paClass II · Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for produc | Device recalls |
| Jan 7, 2016 | Catalog Number: 9001408 UMBILICAL VESSEL CATHETER KIT Used by medical staff to perform surgical procedures and patient care procedures Class II · Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for produc | Device recalls |
| Jan 7, 2016 | Catalog Number: 900582 UTILITY DRAPE WITH TAPE, SMS Used by medical staff to perform surgical procedures and patient care procedures sucClass II · Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for produc | Device recalls |
| Jan 7, 2016 | Catalog Number: 900946 STRABISMUS SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such asClass II · Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for produc | Device recalls |
| Jan 7, 2016 | Catalog Number: 9002830 ORTHOPEDIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such aClass II · Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for produc | Device recalls |
| Jan 5, 1998 | FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633K974647 · KKX | 510(k) clearances |
| Dec 4, 1997 | GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)K971920 · FYA | 510(k) clearances |
| Nov 25, 1996 | SUCTION CATHETER TRAY PRODUCT NO. 900277K964011 · LRO | 510(k) clearances |
| Oct 4, 1996 | URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)K962652 · KNX | 510(k) clearances |
| Sep 27, 1996 | CUSTOMED BLOOD EXTRACTION KITK962596 · GJE | 510(k) clearances |
| May 9, 1996 | UNIVERSAL DRAINAGE TRAYK961442 · FCM | 510(k) clearances |
| Oct 2, 1995 | STERIMED STERIZATION WRAPPER (NON-STERILE)K953678 · FRG | 510(k) clearances |
Names and Identifiers
- Appears as
- Website
- customedhealing.com
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built