510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DEN160012Unknown

D2 Dressing

Z-Medica, LLC, Wallingford CT / Direct, Unknown
FDA source (opens on fda.gov)

DEN160012 is the FDA 510(k) clearance record for D2 Dressing, a class II device, cleared for Z-Medica, LLC on under FDA product code POD (Temporary, Internal Use Hemostatic). FDA's definition for product code POD reads: "Intended to control severely bleeding wounds". FDA records list 14 510(k) clearances for Z-Medica, LLC, from to . As of , FDA records show no recalls naming DEN160012.

Clearance record

Decision date
Received
(471 days to decision)
Product code
POD Temporary, Internal Use Hemostatic
Regulation
21 CFR 878.4454
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Z-Medica, LLC 4 Fairfield Blvd., Wallingford CT
Third party review
No

Clearances, product code POD

Trailing 12 months

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

FDA records show no clearances under product code POD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code POD, 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