Data / Medical devices / United States / Tacmed Solutions, LLC

Tacmed Solutions, LLC: FDA-registered device maker in Anderson, SC, United States, 2 510(k) clearances

Name: Tacmed Solutions, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Tacmed Solutions, LLC is registered with the FDA (registration 3005853033) in Anderson, SC, United States. It lists 12 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 13, 2011. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005853033
Address: 1250 Harris Bridge Rd, Anderson, SC, United States, 29621
Owner or operator: TACMED SOLUTIONS, LLC (9090046)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: July 21, 2006
Registered through: 2026
Brand names listed: BLAST BANDAGE, Compact Trauma Bandage (CTB/TR011), Control Wrap, ESMARK, Foxtrot Litter, HEL-BLKT - Helios Blanket, HELIOS-K - Helios System, HELIOS-KW - Helios System with Warming and more

Devices it lists

Device	Product code	Class	Role	Source
Bandage, Elastic	FQM	1	Repackager or relabeler	accessdata.fda.gov
Cricothyrotomy Kit	OGP	2	Specification developer	accessdata.fda.gov
Device, Fixation, Tracheal Tube	CBH	1	Specification developer	accessdata.fda.gov
Dressing, Compression	MHW	1	Specification developer	accessdata.fda.gov
Hemostatic Wound Dressing Without Thrombin Or Other Biologics	QSY	U	Specification developer	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Repackager or relabeler	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Specification developer	accessdata.fda.gov
Retractor	GAD	1	Specification developer	accessdata.fda.gov
Scalpel, One-Piece	GDX	1	Specification developer	accessdata.fda.gov
Stretcher, Hand-Carried	FPP	1	Specification developer	accessdata.fda.gov
Syringe, Piston	FMF	2	Repackager or relabeler	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 13, 2011	K110771	BD SINGLE USE, HYPODERMIC SYRINGE	FMF	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
August 25, 2009	K092357	CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2	QSY	Substantially Equivalent	Hem Con Medical Technologies, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 17, 2018	80157	Class II	Terminated	BLAST Bandage, sterile.	Blast Bandages (part# BLAST) with Lot# 0617 were not terminally sterilized.	accessdata.fda.gov

Compare with other makers

Updated May 13, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.