Data / Medical devices / United States / Wolf X-Ray Corp

Wolf X-Ray Corp: FDA-registered device maker in Battleboro, NC, United States, 1 510(k) clearance

Name: Wolf X-Ray Corp FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Wolf X-Ray Corp is registered with the FDA (registration 2431224) in Battleboro, NC, United States. It lists 29 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 27, 2009. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 2431224
Address: 133 Wolf Road, Battleboro, NC, United States, 27809
Owner or operator: Wolf X-Ray Corp (2431224)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed: November 7, 1977
Registered through: 2027
Brand names listed: APRON (LEAD), APRON PROTECTIVE, All-Bite, Digi Loops, BARRIER, Barium Cup, Bite Block Baggies, Bullseye Alignment Device, Butterfly Safety Shield and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Manufacturer	accessdata.fda.gov
Aligner, Beam, X-Ray	EHA	1	Repackager or relabeler	accessdata.fda.gov
Apron, Leaded	EAJ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Apron, Protective	IWO	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Barrier, Control Panel, X-Ray, Movable	IWX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Camera, Surgical And Accessories	KQM	1	Manufacturer, Specification developer	accessdata.fda.gov
Cassette, Radiographic Film	IXA	2	Repackager or relabeler	accessdata.fda.gov
Container, Liquid Medication, Graduated	KYW	1	Repackager or relabeler	accessdata.fda.gov
Curtain, Protective, Radiographic	IWQ	1	Manufacturer	accessdata.fda.gov
Film, Radiographic	IWZ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Grid, Radiographic	IXJ	1	Repackager or relabeler	accessdata.fda.gov
Holder, Film, X-Ray	EGZ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Holder, Radiographic Cassette, Wall-Mounted	IXY	1	Repackager or relabeler	accessdata.fda.gov
Illuminator, Radiographic-Film	IXC	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Instrument, Compression	HWN	1	Manufacturer	accessdata.fda.gov
Magnifier, Hand-Held, Low-Vision	HJF	1	Repackager or relabeler	accessdata.fda.gov
Marker, Skin	FZZ	1	Manufacturer	accessdata.fda.gov
Mask, Surgical	FXX	2	Repackager or relabeler	accessdata.fda.gov
Paper, Articulation	EFH	1	Manufacturer	accessdata.fda.gov
Radiographic Protective Glove	IWP	1	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Respirator, Surgical	MSH	2	Repackager or relabeler	accessdata.fda.gov
Screen, Intensifying, Radiographic	EAM	1	Repackager or relabeler	accessdata.fda.gov
Shield, Eye, Radiological	IWS	1	Repackager or relabeler	accessdata.fda.gov
Shield, Gonadal	IWT	1	Manufacturer	accessdata.fda.gov
Shield, Protective, Personnel	KPY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Support, Patient Position	CCX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Surgical Table Cushion	LWG	1	Manufacturer	accessdata.fda.gov
System, X-Ray, Film Marking, Radiographic	JAC	1	Repackager or relabeler	accessdata.fda.gov
Unit, Operative Dental, Accessories	NRD	1	Specification developer	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 27, 2009	K090131	DS N95 SURGICAL MASKS AND FLAT SURGICAL	MSH	Substantially Equivalent	Shanghai Dasheng Health Products	accessdata.fda.gov

Compare with other makers

Updated April 27, 2009. 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.