Customed, Inc.
Customed, Inc. holds FDA 510(k) medical device clearances, first cleared 1990, most recent 1998, with 682 FDA device recalls on record.
Top product codes for Customed, Inc.
FDA recalls by Customed, Inc.
10 most recent of 682- Z-1475-2016 — Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Z-1488-2016 — Catalog Number: 900782 SKIN STAPLE REMOVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Z-1443-2016 — Catalog Number: 9002167 LITHOTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Z-1397-2016 — Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Z-1417-2016 — Catalog Number: 9001294 PREMIUM CESAREAN PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Z-1446-2016 — Catalog Number: 9002256 NEUROSURGERY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Z-1436-2016 — Catalog Number: 9001765 MINOR LACERATION TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Z-1441-2016 — Catalog Number: 9002123 KNEE ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Z-1407-2016 — Catalog Number: 900080 CYSTOSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Z-1457-2016 — Catalog Number: 9002766 SHOULDER PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Customed, Inc.
- K974647 — FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633
- K971920 — GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)
- K964011 — SUCTION CATHETER TRAY PRODUCT NO. 900277
- K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)
- K962596 — CUSTOMED BLOOD EXTRACTION KIT
- K961442 — UNIVERSAL DRAINAGE TRAY
- K953678 — STERIMED STERIZATION WRAPPER (NON-STERILE)
- K950295 — WOUND CLOSURE/LACERATION TRAY
- K942177 — FOLEY CATHETERIZATION TRAY
- K925017 — IV PREP KIT (NON-STERILE)
- K925018 — IV PREP KIT W/O DRESSING (NON-STERILE)
- K930986 — BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560
- K925020 — TRACHEOSTOMY CARE KIT (STERILE)
- K924809 — IRRIGATION TRAY W/ BULB SYRINGE
- K925015 — STERILE SUTURE REMOVAL KIT
- K925021 — TPN TRAY (STERILE)
- K925016 — PREP SHAVE KIT (NON-STERILE)
- K925022 — SURGICAL TRAY (STERILE)
- K904693 — CUSTOMED CARDIOVASCULAR PACK
- K904694 — CUSTOMED ANGIODRAPE PACK FEMORAL
- K901705 — CUSTOMED CYSTO PACK II
- K902191 — CUSTOMED LAP PACK II
- K902032 — O. B. PACK IV
- K902274 — CUSTOMED CYSTO PACK I
- K902884 — CUSTOMED BASIC PACK I
- K902885 — CUSTOMED BASIC PACK II
- K902886 — CUSTOMED BASIC PACK III
- K902887 — CUSTOMED ARTHROSCOPY PACK
- K902888 — CUSTOMED ORTHOPEDIC II
- K903336 — CUSTOMED HIP PACT
- K902273 — O. B. PACK III
- K902271 — O. B. PACK I
- K902272 — O. B. PACK II
- K902029 — CUSTOMED LAP PACK I
- K902030 — CUSTOMED LAP PACK III
- K902031 — CUSTOMED LAP PACK IV
Data sourced from openFDA. This site is unofficial and independent of the FDA.