Monoject Prefill 0.9% Sodium Chloride Flush Syringe

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K011283 ↗

FDA Product Code

NGT

Device Class

Class II

Regulation

21 CFR Part 880.5200

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Mahurkar Oplus Catheter, Model 13.5 Fr Open recall

  Class II

  FDA 510(k) K030209 Active Cleared 13 May 2003

• Kendall Model 7325 Scd Response Compression System, Model 7325

  Class II

  FDA 510(k) K992079 Active Cleared 29 Sep 1999

• Kerlix Md Antimicrobial Gauze Dressing

  Class I

  FDA 510(k) K990530 Active Cleared 31 Jan 2000

• Kendall Argyle Neonatal/Pediatric Picc, Model 43311

  Class II

  FDA 510(k) K061936 Active Cleared 9 Aug 2006

• Filac Fas Temp Electronic Thermometer

  Class II

  FDA 510(k) K003313 Active Cleared 11 Jan 2001

• Tandem-Cath 10 Fr. Catheter System, Model Multiple Code Numbers

  Class II

  FDA 510(k) K002902 Active Cleared 9 Apr 2001

See all devices from The Kendall Company →