510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043322Substantially Equivalent

Miramatic Safe Syringe System

Hager Worldwide, Inc., Andover MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043322 is the FDA 510(k) clearance record for MIRAMATIC SAFE SYRINGE SYSTEM, a class II device, cleared for Hager Worldwide, Inc. on under FDA product code EJI (Syringe, Cartridge). FDA records list 3 510(k) clearances for Hager Worldwide, Inc., from to . As of , FDA records show no recalls naming K043322.

Clearance record

Decision date
Received
(231 days to decision)
Product code
EJI Syringe, Cartridge
Regulation
21 CFR 872.6770
Device class
Class II
Review panel
Dental
Applicant
Hager Worldwide, Inc. 4 Lincoln St., Andover MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EJI

Trailing 12 months

FDA records hold no clearances under product code EJI in the trailing twelve months.

FDA records show no clearances under product code EJI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EJI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260