Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009154005

FEI Number

3009154005

Entity Name

MEDICAL OUTFITTERS, INC

City/State/Country

Miami, FL, US

Establishment Address

8062 NW 66th St, Miami, FL 33166, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Medical Outfitters, Inc (Owner Number: 10044808)

Owner / Operator Contact Address

8062 NW 66 Street, Miami, FL 33166, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250318

PMA Number

N/A

All Registered Proprietary Names

nasal Biliary drainage tube Hot Forceps Cytology brush Philips Brilliance 64 Planmed XFI

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2025-07-31
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2018-10-23
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2021-03-09
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2021-03-09
SFV	X-Ray, Computed Tomography, Cone-Beam	Radiology	Class 2	892.1750	2026-04-20

Official Correspondent

Miguel Machuca

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medical Outfitters, Inc

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
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
K243523	Siemens Medical Solutions USA, Inc.	NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime	2025-02-12
K781431	General Electric Co.	ELECTRIC CT/T OPERATOR DISPLAY CONSOLE	1978-09-07
K231574	FUJIFILM Healthcare Americas Corporation	Scenaria View 4.2	2023-10-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2011	GE Medical Systems, LLC	2	HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017	Philips Medical Systems	2	Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017	Philips Medical Systems	2	Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0011-2017	Philips Medical Systems	2	Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0012-2017	Philips Medical Systems	2	Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Similar Registrations

Registration Number	Establishment Name	Location
3016544015	ARCULANT, INC.	Santa Clara, CA, US
1055890	PRINCETON MEDICAL GROUP, INC.	Franklin, TN, US
3004371426	Waldemar Link GmbH & Co. KG	Norderstedt Schleswig-Holstein, DE
3010287737	BAECHLER FEINTECH AG	Hoelstein Basel-Landschaft, CH
3003675041	SURGICAL INSTRUMENTS BELGIUM SA	GEMBLOUX Namur, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009154005. Last updated year: 2026. Please use registration number 3009154005 when referencing this establishment in official correspondence.