Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1066635

FEI Number

3003184737

Entity Name

Hill-Rom Company, Inc.

City/State/Country

Ladson, SC, US

Establishment Address

4279-U Crosspoint Drive, Ladson, SC 29456, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

BAXTER HEALTHCARE CORPORATION (Owner Number: 1417572)

Owner / Operator Contact Address

One Baxter Parkway, Deerfield, IL 60015, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Surgical Light (TruLight 5000/3000) and accessories [Baxter] OR Camera (TruVidia HD, 4K Camera, 4K Refreshing Unit) and accessories [Baxter] Surgical Light System (TruLight 3000, TruLight 5000) and accessories [Baxter] Advance Table [Allen] PST and accessories [Baxter] TruSystem and accessories [Baxter] Surgical Light (TruLight 5000/3000) and accessories [Baxter] Surgical Light (TruLight 5000/3000) and accessories [Baxter] PST and accessories [Baxter] TruSystem and accessories [Baxter] PST and accessories [Baxter] TruSystem and accessories [Baxter] Helion Head Positioning Accessories [Baxter] Surgical Light (TruLight 5000/3000, Helux Pro) and accessories [Baxter]

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSS	Light, Surgical, Floor Standing	General, Plastic Surgery	Class 2	878.4580	2022-01-10
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2022-01-10
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2022-01-10
GDC	Table, Operating-Room, Electrical	General, Plastic Surgery	Class 1	878.4960	2022-01-10
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2022-01-10
FSQ	Light, Surgical, Instrument	General, Plastic Surgery	Class 2	878.4580	2022-01-10
JEA	Table, Surgical With Orthopedic Accessories, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2022-01-10
KXJ	Table, Radiologic	Radiology	Class 2	892.1980	2022-01-10
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2022-01-10
IWY	Holder, Head, Radiographic	Radiology	Class 1	892.1920	2022-01-10
FQP	Lamp, Operating-Room	General, Plastic Surgery	Class 2	878.4580	2022-01-10

Official Correspondent

Maha Nolasco

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BAXTER HEALTHCARE CORPORATION

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014226707	BARDY DIAGNOSTICS, INC.	Bellevue, WA, US
3019257308	VIDEOMED SRL	LIMENA Padova, IT
1314492	Baxter Healthcare Corporation	MEDINA, NY, US
3007143268	Baxter Medical Systems GmbH + Co. KG	SAALFELD Thuringia, DE
8010130	BAXTER SA	LESSINES Hainaut, BE

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-0040-2017	Trumpf Medical Systems, Inc.	1	Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material Number 1607822 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system
Z-0041-2017	Trumpf Medical Systems, Inc.	1	Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.
Z-0042-2017	Trumpf Medical Systems, Inc.	1	Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS, Material Number 1501878 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.
Z-0043-2017	Trumpf Medical Systems, Inc.	1	Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system
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

Similar Registrations

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1836161	ASPEN SURGICAL PRODUCTS, INC.	Caledonia, MI, US
3015131225	COGNATE INDIA	NEW DELHI, IN
3021559257	CAF MEDICAL SOLUTIONS INC	Hockley, TX, US
3007143268	Baxter Medical Systems GmbH + Co. KG	SAALFELD Thuringia, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1066635. Last updated year: 2026. Please use registration number 1066635 when referencing this establishment in official correspondence.