Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2183570

FEI Number

2183570

Entity Name

MCLEAN MEDICAL & SCIENTIFIC

City/State/Country

Saint Paul, MN, US

Establishment Address

328 State Street, Saint Paul, MN 55107, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MCLEAN MEDICAL & SCIENTIFIC (Owner Number: 2183570)

Owner / Operator Contact Address

328 State Street, --, Saint Paul, MN 55107, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2013-02-13
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-01-11
EME	Punch, Biopsy, Surgical	Dental	Class 1	872.4565	2012-12-20
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-12-20
FBM	Cannula And Trocar, Suprapubic, Non-Disposable	Gastroenterology, Urology	Class 1	876.5090	2012-12-20
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2012-12-20
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2012-12-20
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1985-02-07
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2013-02-13
KDG	Chisel (Osteotome)	General, Plastic Surgery	Class 1	878.4820	2012-12-20
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-12-20
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2013-02-13
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-01-11
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2013-02-13
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	1985-02-07
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2013-11-07
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-01-11
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2021-02-04
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-01-11
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-01-11
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2012-12-20
GCT	Light Source, Endoscope, Xenon Arc	Gastroenterology, Urology	Class 2	876.1500	2012-12-20
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2012-12-20
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-01-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MCLEAN MEDICAL & SCIENTIFIC

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
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
K894785	Fdt Precision Machine Co., Inc.	SURGICAL CHISEL/OSTEOTOME	1989-08-18
K010427	Walter Lorenz Surgical, Inc.	LORENZ FIDUCAIL SCREW	2001-03-15
K812744	Progress Mankind Technology	LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER	1981-12-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0001-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0002-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0005-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Z-0006-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.

Similar Registrations

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3001084743	Bailey Instruments Ltd	Manchester, GB
3006017180	BBF STERILISATIONSSERVICE GMBH	Kernen Baden-Wurttemberg, DE
2133928	Metal Craft Machine & Engineering, Inc.	Elk River, MN, US
3011024991	Nypro Inc (Maple Grove)	Maple Grove, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2183570. Last updated year: 2026. Please use registration number 2183570 when referencing this establishment in official correspondence.