Data / Medical devices / Italy / Omnia SRL

Omnia SRL: FDA-registered device maker in FIDENZA Parma, Italy, 4 510(k) clearances

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

Omnia SRL is registered with the FDA (registration 3004361903) in FIDENZA Parma, Italy. It lists 24 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 6, 2018. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3004361903
Address: Via F.delnevo 190, FIDENZA Parma, Italy, 43036
Owner or operator: Omnia SRL (9059817)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: November 24, 2003
Registered through: 2027
Brand names listed: Hu-Friedy, IRRIGATION LINE, LIGHT BARRIER, MAXIL, NON STERILE OPERATOR PROTECTION, OMNICAPS, OMNITEX C, OMNITEX U and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Retractor, Dental	EIF	1	Repackager or relabeler	accessdata.fda.gov
Accessory, Surgical Apparel	LYU	1	Manufacturer	accessdata.fda.gov
Cap, Surgical	FYF	1	Repackager or relabeler	accessdata.fda.gov
Catheter, Irrigation	GBX	1	Contract manufacturer	accessdata.fda.gov
Chair, Dental, Without Operative Unit	NRU	1	Manufacturer	accessdata.fda.gov
Drape, Adhesive, Aerosol	KGT	1	Manufacturer	accessdata.fda.gov
Drape, Surgical, Antimicrobial	KKX	2	Manufacturer	accessdata.fda.gov
Film, Camera, Surgical	FXT	1	Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Specification developer	accessdata.fda.gov
General Surgery Tray	LRO	2	Manufacturer	accessdata.fda.gov
Gown, Surgical	FYA	2	Manufacturer	accessdata.fda.gov
Holder, Film, X-Ray	EGZ	1	Specification developer	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Repackager or relabeler	accessdata.fda.gov
Mask, Surgical	FXX	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Mouthpiece, Saliva Ejector	DYN	1	Repackager or relabeler	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Manufacturer	accessdata.fda.gov
Operating Room Accessories Table Tray	FWZ	1	Manufacturer	accessdata.fda.gov
Punch, Biopsy, Surgical	EME	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Suit, Surgical	FXO	1	Repackager or relabeler	accessdata.fda.gov
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	NBY	2	Specification developer	accessdata.fda.gov
Table And Attachments, Operating-Room	BWN	1	Specification developer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Manufacturer	accessdata.fda.gov
Unit, Operative Dental, Accessories	NRD	1	Manufacturer	accessdata.fda.gov
Unit, Oral Irrigation	EFS	1	Contract 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 6, 2018	K180630	PTFE SURGICAL SUTURE	NBY	Substantially Equivalent	Omnia Spa	accessdata.fda.gov
February 12, 2014	K132464	PTFE SURGICAL SUTURE	NBY	Substantially Equivalent	Omnia Spa	accessdata.fda.gov
June 23, 2011	K110724	SURGICAL PROCEDURE PACKS	FYA	Substantially Equivalent	Omnia Spa	accessdata.fda.gov
August 29, 1991	K911334	MASK, SURGICAL APPAREL	FXX	Substantially Equivalent	Thai Hospital Products Co., Ltd.	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
March 30, 2021	87680	Class II	Terminated	Omnia Soft Tissue Punch is a dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling	Omnia SRL received a notification from the contract manufacturer informing them of inadequate sterilization processes which have been taking place at their contracted sterilizing facility since 2016.	accessdata.fda.gov

Compare with other makers

Updated April 29, 2021. 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.