Groman Inc.
United Statesfrom the FDA registration address FDA FEI 3004361444
Groman Inc. is a medical device manufacturer, with 22 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) and 1 FDA recall as of 15 Nov 2026.
- Devices
- 22
- Registrations
- FDA
- FDA recalls
- 1
Registry facts
- Registries
- FDA GUDID 21
- FDA 510(k) 1
- Device classes
- FDA Class II 19
- FDA Class I 3
- FDA recalls
- Identifiers
- FDA FEI 3004361444
- DUNS 020124663
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Groman Inc. makes
Groman Inc. manufactures dental abrasive air jet systems, single-use rebreathing aerosol face masks, non-rebreathing oxygen face masks, and particulate respirator filters or cartridges. Specific products include the Etchmaster dental system, the SafetyO2 oxygen mask, the SafetyFilta cartridge, and the SafetyNeb mask.
These products are listed in the FDA 510(k) premarket notification database and the FDA Unique Device Identification (UDI) system.
Catalogue
Search and filter all 22 devicesCompany details
- FDA FEI number
- 3004361444
- DUNS number
- 020124663
- Address
- 2000 Banks Rd Ste G1, Coconut Creek, FL, 33063
- Phone
- 800-906-9298
FDA recalls
FDA recall records list 1 recall initiated by GROMAN INC., initiated on 2010-12-13. By recorded status: 1 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2010
- 13 Dec 2010 Z-0742-2012 Unclassified (pre-2012) Terminated 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 cartridges.
Frequently asked questions
How many devices does GROMAN INC. have in the registry?
The registry currently lists 22 devices for GROMAN INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list GROMAN INC.'s devices?
Among its 22 most recently registered devices, GROMAN INC. has devices listed in FDA 510(k) (1 device) and FDA GUDID (21 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do GROMAN INC.'s devices fall under?
Among its 22 most recently registered devices, the classes recorded for GROMAN INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for GROMAN INC.?
FDA recall records list 1 recall initiated by GROMAN INC., the most recent initiated on 13 Dec 2010. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from GROMAN INC. in the registry?
The most recently registered devices listed for GROMAN INC. include Etchmaster EM-L-N-RB, Etchmaster PM-X-L-RB, Etchmaster EM-S-O-RB and SafetyO2 AM-OXY-FP.