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Artisan Medical: FDA-registered device maker in Medford, NJ, United States, 2 510(k) clearances

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

Artisan Medical is registered with the FDA (registration 3006591312) in Medford, NJ, United States. It lists 18 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 17, 2014. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006591312
Address: 55 Highbridge Blvd, Medford, NJ, United States, 08055
Owner or operator: Artisan Medical (10029903)
Roles: Repackager or relabeler
First device listed: January 14, 2013
Registered through: 2026
Brand names listed: Adson Brown Forceps; Adson Dressing Forceps; Adson Forceps; Adson Tissue Forceps; Adson-Brown Tissue Forceps; Adson-DeBa, Artisan Suture Passer Joystick Suture Guide, Baby Iris Scissors; Baby Lexer Scissors; Baby Metzenbaum Scissors; Cottle Scissors; Freeman Facelift Scissors; Freeman-K, BiPolar Forceps, Breisky Lighted Retractor, Burke Biopsy Forceps; Eppendorfer Biopsy Forceps; Kevorkian Biopsy Forceps; Schubert Biopsy Forceps; Tischler Biopsy For, Charnely Retractor, Coated LLETZ Forceps and more

Devices it lists

Device	Product code	Class	Role	Source
Dilator, Cervical, Fixed Size	HDQ	1	Repackager or relabeler	accessdata.fda.gov
Forceps	HTD	1	Repackager or relabeler	accessdata.fda.gov
Forceps, Biopsy, Gynecological	HFB	1	Repackager or relabeler	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Repackager or relabeler	accessdata.fda.gov
Holder, Needle, Gastroenterologic	FHQ	1	Repackager or relabeler	accessdata.fda.gov
Hook, Gastro-Urology	FHB	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Ligature Passing And Knot Tying	HCF	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Repackager or relabeler	accessdata.fda.gov
Laparoscopic Accessories, Gynecologic	NWV	1	Repackager or relabeler	accessdata.fda.gov
Light, Surgical, Fiberoptic	FST	2	Repackager or relabeler	accessdata.fda.gov
Retractor	GAD	1	Repackager or relabeler	accessdata.fda.gov
Retractor, Fiberoptic	FDG	1	Repackager or relabeler	accessdata.fda.gov
Scissors, General, Surgical	LRW	1	Repackager or relabeler	accessdata.fda.gov
Speculum, Rectal	FFQ	1	Repackager or relabeler	accessdata.fda.gov
Speculum, Vaginal, Metal	HDF	1	Repackager or relabeler	accessdata.fda.gov
Speculum, Vaginal, Nonmetal	HIB	2	Repackager or relabeler	accessdata.fda.gov
Table, Surgical With Orthopedic Accessories, Manual	JEB	1	Repackager or relabeler	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Repackager or relabeler	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
January 17, 2014	K132668	IOB DISPOSABLE SPECULUM	HIB	Substantially Equivalent	Iob Medical, Inc.	accessdata.fda.gov
September 15, 2006	K061690	SURGICAL HEADLIGHT	FST	Substantially Equivalent	Gulf Medical Fiberoptics	accessdata.fda.gov

Compare with other makers

Updated January 17, 2014. 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.