Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012165496

FEI Number

3012165496

Entity Name

S.I.M.E.O.N. MEDICAL USA, LLC

City/State/Country

Greenville, SC, US

Establishment Address

33 Market Point Drive, Greenville, SC 29607, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

S.I.M.E.O.N. MEDICAL GmbH & Co. KG (Owner Number: 9093739)

Owner / Operator Contact Address

In Grubenacker 18, --, TUTTLINGEN, DE-BW 78532, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sim.MOVE 800 Sim.LED 7000 MC Sim.LED 7000 SC Sim.LED 4500 Sim.LED 5000 MC Sim.LED 5000 SC Sim.LED 500 MC Sim.LED 500 SC Sim.LED 700 SC Sim.LED 700 MC Sim.LED 450 SC Sim.LED 450 MC Sim.LED 8000 SC Sim.LED 8000 MC Light, Surgical_Wall Mounted Sim.LED 3500+ Sim.LED 350 Sim. LED 5000 MC Sim. LED 7000 MC Sim. LED 5000 SC Sim.LED 4500 Sim.LED 450 MC Sim. LED 7000 SC Sim.LED 700 MC Sim.LED 500 MC Sim.LED 450 SC Sim.LED 500 SC Sim.LED 700 SC Sim.LED 8000 MC Sim.LED 8000 SC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDC	Table, Operating-Room, Electrical	General, Plastic Surgery	Class 1	878.4960	2021-02-17
FSS	Light, Surgical, Floor Standing	General, Plastic Surgery	Class 2	878.4580	2014-09-08
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2025-02-10
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2021-11-25
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2014-09-08

Official Correspondent

Andreas Muehlenbeck

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

S.I.M.E.O.N. MEDICAL GmbH & Co. KG

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006223081	S.I.M.E.O.N. MEDICAL GMBH & Co.KG	TUTTLINGEN Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K780666	Castle Co.	DAYSTAR SELECTRA & SELECTRA/ORBITER	1978-04-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0029-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0030-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0031-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0032-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

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3003900596	SCHAERER MEDICAL AG	Muensingen Bern, CH
3008388379	Mizuho (Thailand) Co., Ltd.	Bang Pa-In Phra Nakhon Si Ayutthaya, TH
3011547624	MIZUHO CORPORATION	BUNKYO-KU Tokyo, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012165496. Last updated year: 2026. Please use registration number 3012165496 when referencing this establishment in official correspondence.