Data / Medical devices / United States / Groman Inc.

Groman Inc.: FDA-registered device maker in Coconut Creek, FL, United States, 1 510(k) clearance

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

Groman Inc. is registered with the FDA (registration 3004361444) in Coconut Creek, FL, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 15, 2003. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Groman Inc.

FDA registration number: 3004361444
Address: 2000 Banks Rd Ste G1, Coconut Creek, FL, United States, 33063
Owner or operator: GROMAN INC. (9054890)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: December 4, 2007
Registered through: 2026
Brand names listed: CircuitGlow, EtchMaster, PowderMaster, PrepMaster, ProphyMaster, SafetyFilta, SafetyNeb, SafetyO2 and more

Devices it lists

Device	Product code	Class	Role	Source
Airbrush	KOJ	2	Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Lamp, Surgical	FTD	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Mask, Oxygen, Low Concentration, Venturi	BYF	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Mask, Oxygen, Non-Rebreathing	KGB	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	CCQ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Tubing, Pressure And Accessories	BYX	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
April 15, 2003	K030292	GROMAN PREPMASTER	KOJ	Substantially Equivalent	Groman, 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
December 13, 2010	58889	Not yet classified	Terminated	New Label: EtchMaster *Cordless Handpiece*P/N 797 www.GromanDental.com 1800-906-9298 HAZARD WARNING: Using CO2 cartridges from other suppliers may cause an operational hazard and will void the warrantee. Old Label: E	Groman Inc. of Margate, FL recalled their product Cordless Etcher Air Brush. When non-conforming cartridges are inserted into the Cordless Etcher they can induce excessive stresses on the device causing cracks in the plastic housing of the device. These crack can lead to a hazardous situation due to the high pressure of the gas contained in the CO2 cartridge	accessdata.fda.gov

Compare with other makers

Updated January 13, 2012. 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.