Data / Medical devices / United States / Medical Outfitters, Inc

Medical Outfitters, Inc: FDA-registered device maker in Miami, FL, United States, 4 510(k) clearances

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

Medical Outfitters, Inc is registered with the FDA (registration 3009154005) in Miami, FL, United States. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 26, 2025. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Medical Outfitters, Inc

FDA registration number: 3009154005
Address: 8062 NW 66th St, Miami, FL, United States, 33166
Owner or operator: Medical Outfitters, Inc (10044808)
Roles: Repackager or relabeler, Reprocessor
First device listed: October 23, 2018
Registered through: 2026
Brand names listed: Cytology brush, GE Signa Excite HDxt HD 23 1.5T, Hot Forceps, Philips Brilliance 64, Planmed XFI, nasal Biliary drainage tube

Devices it lists

Device	Product code	Class	Role	Source
Forceps	HTD	1	Repackager or relabeler	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Repackager or relabeler, Reprocessor	accessdata.fda.gov
System, Nuclear Magnetic Resonance Spectroscopic	LNI	2	Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Repackager or relabeler	accessdata.fda.gov
X-Ray, Computed Tomography, Cone-Beam	SFV	2	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
September 26, 2025	K250318	Planmed XFI	SFV	Substantially Equivalent	Planmed OY	accessdata.fda.gov
August 8, 2016	K160743	Philips Ingenuity CT	JAK	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.	accessdata.fda.gov
September 21, 2005	K052293	GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
July 21, 2004	K041112	MAGNETOM ESPREE SYSTEM	LNH	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov

Compare with other makers

Updated September 26, 2025. 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.