FDA Registration
Active
🇺🇸 United States
HILL-ROM, INC.
Reg #: 1824206
·
FEI: 1824206
·
Expires 2026
Products
29
Proprietary Names
85
Establishment Types
5
Classifications
29
Registration Details
- Registration Name
- HILL-ROM, INC.
- Registration Number
- 1824206
- FEI Number
- 1824206
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1069 State Route 46 East
- City
- Batesville
- State
- IN
- ZIP
- 47006
- Country
- US
Regulatory Submissions
- 510(k) Number
- K143414
Owner / Operator
- Firm Name
- BAXTER HEALTHCARE CORPORATION
- Operator Number
- 1417572
- Address
- One Baxter Parkway
- City
- Deerfield
- State
- IL
- Postal Code
- 60015
- Country
- US
- Correspondent
- Maha Nolasco
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Chair And Table, Medical | KMN | Class 1 | General Hospital | No | 2022-01-10 |
| Bed, Ac-Powered Adjustable Hospital | FNL | Class 2 | General Hospital | No | 2022-01-10 |
| Bed, Flotation Therapy, Powered | IOQ | Class 2 | Physical Medicine | No | 2022-01-10 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2022-01-10 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 1991-06-21 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2022-01-10 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2023-02-16 |
| Mattress, Flotation Therapy, Non-Powered | IKY | Class 1 | General Hospital | No | 1995-08-01 |
| Table, Obstetric (And Accessories) | KNC | Class 2 | Obstetrics/Gynecology | No | 2022-03-31 |
| Ear, Nose, And Throat Stereotaxic Instrument | PGW | Class 2 | Neurology | No | 2025-04-25 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2022-01-10 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2022-01-10 |
| Lift, Patient, Non-Ac-Powered | FSA | Class 1 | General Hospital | No | 2022-01-10 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 1991-06-21 |
| Bed, Manual | FNJ | Class 1 | General Hospital | No | 2022-01-10 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 1992-09-11 |
| Bed, Air Fluidized | INX | Class 2 | Physical Medicine | No | 2022-01-10 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2025-04-25 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | Class 1 | Gastroenterology, Urology | No | 2022-01-10 |
| Accessories, Traction | ILZ | Class 1 | Physical Medicine | No | 1991-06-21 |
| Bassinet, Hospital | NZG | Class 2 | General Hospital | No | 2022-01-10 |
| Table, Operating-Room, Electrical | GDC | Class 1 | General, Plastic Surgery | No | 2022-01-10 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 1992-06-05 |
| Stretcher, Wheeled, Powered | INK | Class 2 | Physical Medicine | No | 2024-09-30 |
| Bariatric Bed | OSI | Class 2 | General Hospital | No | 2022-01-10 |
| Stretcher, Wheeled | FPO | Class 2 | General Hospital | No | 2022-01-10 |
| Component, Traction, Non-Invasive | KQZ | Class 1 | Orthopedic | No | 2022-01-10 |
| Chair, Adjustable, Mechanical | INN | Class 1 | Physical Medicine | No | 2022-01-10 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2022-01-10 |
Proprietary Names
3 position recliner
Wireless Connectivity Module
Allen
F-YFES Finned Stirrup, Set
ALLEN DISPOSABLES SURG
Affinity Drapes
Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense
Centrella
Accumax
Compella
NP100
Progressa
NP50
Centrella Surface
Progressa+
Dynamo Series Stretchers
Stretcher Mattress
Affinity
StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)
TotalCare Modular Therapy Bed System
HANDYSHEET
HANDYTUBE
HANDYBELT
Hill-Rom Bed Trapeze
Multistrap
Liko Stretchers
Likoguard, FreeSpan
Liko slings, M220, M230, Golvo, Multirall, Sabina, Uno, Liftpants, Liftsheet, Liko straps, Liko vests
Viking
LikoRall
RepoSheet
Yellofins Apex (Allen)
Hillrom patient positioners
ALLEN patient positioners
Progressa head extension
Hill-Rom 305/405 Bed
Advanta
Novum IQ Hub
HR1000
VersaCare
GPAC
CareAssist
Long Term Care (LTC)
Advanta2k
BasicCare
HR 100 Low Bed, Resident LTC Bed, Sentinel Bed
Hill-Rom IV Poles
Hillrom ReadyConnect
Envella
STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM
Uro Catcher
traction, accessories
Hill-Rom bassinet
Advance Table [Allen]
PST and accessories [Baxter]
TruSystem and accessories [Baxter]
Allen Traction Boot
Allen Traction Boot Clamp
ATB Modular Attachment for Steris
HDS, Traction Boot
Hill-Rom Traction Adaptors
Allen Traction Boot for Mizuho OSI Systems
Traction Attachment
ATB - Modular Attachment for Mizuho OSI System
Allen Traction Boot - Modular
Boot Assembly, Traction Device, OT 1000
FRACTURE FRAME ADAPTORS
TRACTION BOOT ASSY MAQUET 10061TB
Hand
Hill-Rom Stretchers (Procedural, Transport, Surgical, Trauma, OB/GYN)
TotalCare, P500, Progressa, VersaCare, Synergy Air Elite
Envision LAL Therapy Surface
Silkair Low Airloss Therapy
pro+
Envision / E700
Compella, Triflex II, Sentinel
ExcelCare ES Bariatric, TotalCare Bariatric
Hill-Rom 1039/1048 Bariatric Bed
Fusion Compact Navigation System
finger trap
CHAIR - ADJUSTABLE MANUAL
ADJUSTABLE
MECHANICAL (MULTIPLE BRANDS)
Barton Chair
bariatric wheelchair
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)