Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006591312

FEI Number

3006591312

Entity Name

ARTISAN MEDICAL

City/State/Country

Medford, NJ, US

Establishment Address

55 Highbridge Blvd, Medford, NJ 08055, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Artisan Medical (Owner Number: 10029903)

Owner / Operator Contact Address

55 Highbridge Blvd, Medford, NJ 08055, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IUD INSERTION KIT Rosenblatt Surgical Caddy Fiber Optic Light Cords Rectal Spceulums Hill Ferguson Rectal Retractors LITE SPEC brite spec HALO SPECULUM Laparoscopic Scope Warmer Coated LLETZ Forceps BiPolar Forceps Adson Brown Forceps; Adson Dressing Forceps; Adson Forceps; Adson Tissue Forceps; Adson-Brown Tissue Forceps; Adson-DeBa Lees Knee Holder Rectal Blades, Meyerding Blades, Deaver Blades, Iron Martin Arm Wexler Retractor Fan Retractor Kelly Retractor, Malleable Retractor, Balfour Retractor, Rectal Retractor, Posterior and Anterior Retractor, Snake Retractor Charnely Retractor HALO SPECULUM Lucite Stent Reusable Stainless Steel Pilot Guide Heany Simon Lighted Retractor Breisky Lighted Retractor Miyazaki Lighted Retractor St Marks Lighted Retractor Hand Held Needle Holders

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2017-04-12
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2013-06-26
FFQ	Speculum, Rectal	Gastroenterology, Urology	Class 1	876.4730	2013-06-26
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2014-02-12
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2015-12-28
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2013-06-26
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2013-06-26
JEB	Table, Surgical With Orthopedic Accessories, Manual	General, Plastic Surgery	Class 1	878.4950	2019-06-13
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2013-06-26
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2015-03-11
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-11-13
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	Class 1	876.4530	2013-06-26
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2013-06-26

Official Correspondent

James Lees Jr

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Artisan Medical

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K901491	Cuda Products Co.	CUDA SURGICAL LIGHT	1990-06-18
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

Similar Registrations

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3008886285	Flextronics International Kft	Budapest, HU
3012574325	HAKAMA AG	Baettwil Solothurn, CH
3001397320	ROECHLING MEDICAL ROCHESTER L.P.	Rochester, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006591312. Last updated year: 2026. Please use registration number 3006591312 when referencing this establishment in official correspondence.