Company ยท US
Hill-Rom Manufacturing, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2008. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
20recalls (0 in 12 months)
13recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 9, 2008 | K080226 | NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912 Hill-Rom Manufacturing, Inc. | HGM |
| Oct 8, 2003 | K032772 | MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM Hill-Rom Manufacturing, Inc. | HGM |
| Aug 1, 2003 | K031387 | ISOLETTE INFANT INCUBATOR, MODEL C2000E Hill-Rom Manufacturing, Inc. | FMZ |
| Jan 11, 2002 | K014094 | MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM Hill-Rom Manufacturing, Inc. | HGM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 12, 2020 | Hill-Rom Manufacturing, Inc. Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 - Product Usage: use in home and institutional settings and is not intended for ambulance or air tr Terminated |
CBK | K170037 |
| Sep 15, 2017 | HILL-ROM MANUFACTURING, INC. Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability). The firm name on the label is Hill-Rom Services Pte. Ltd., Terminated |
BYI | K163378 |
| Feb 15, 2011 | Hill-Rom Manufacturing, Inc. Flexicair MC3 (Model number: M4000) Low Airloss Therapy Units
For use to prevent pressure sore development and wound deterioration in patients who have significant risk of developing these problems an Terminated |
IOQ | K863047 |
| Feb 15, 2011 | Hill-Rom Manufacturing, Inc. Flexicair II (Model number 13000) Low Airloss Therapy Units
For use to prevent pressure sore development and wound deterioration in patients who have significant risk of developing these problems and Terminated |
IOQ | K863047 |
| Aug 25, 2009 | Hill-Rom Manufacturing, Inc. CLINITRON UP-LIFT" Air Fluidized Therapy Units.
Intended to prevent and/or treat pressure ulcer development and wound deterioration in patients who have a significant risk of developing these problem Terminated |
INX | K920112 |
| Aug 25, 2009 | Hill-Rom Manufacturing, Inc. CLINITRON CII Air Fluidized Therapy Units.
Intended to prevent and/or treat pressure ulcer development and wound deterioration in patients who have a significant risk of developing these problems and Terminated |
INX | K813584 |
| Aug 3, 2009 | Hill-Rom Manufacturing, Inc. Flexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores. Terminated |
IOQ | K863047 |
| Aug 3, 2009 | Hill-Rom Manufacturing, Inc. Flexicair II (model 13000) Low Airloss Therapy Units, for the prevention of pressure sores. Terminated |
IOQ | K863047 |
| Jan 7, 2009 | Hill-Rom Manufacturing, Inc. Pro 2000, Alternating Pressure Air Flotation Mattress, Model number 5613
Designed to provide enhanced static and pulsation pressure relieving therapies. Terminated |
FNM | None listed |
| Jan 7, 2009 | Hill-Rom Manufacturing, Inc. Synergy Air Squared, Alternating Pressure Air Flotation Mattress, Model number 6361.
Designed to prevent and treat decubitus ulcers. This is accomplished by achieving interface pressures well below Terminated |
FNM | None listed |
| Jan 7, 2009 | Hill-Rom Manufacturing, Inc. Synergy Dynamic, Powered Patient Rotation Bed, Model number 5607.
Designed to provide enhanced static, pulsation and rotational pressure relieving therapies. Provides sixteen pressure zones for cust Terminated |
FNM | None listed |
| Jan 7, 2009 | Hill-Rom Manufacturing, Inc. Synergy Pulse, Powered Flotation Therapy bed, Model number 5609.
Designed to provide enhanced static and pulsation pressure relieving therapies. Provides sixteen pressure zones for customizing the s Terminated |
FNM | None listed |
| Oct 7, 2008 | Hill-Rom Manufacturing, Inc. Envision E700 Low Airloss Therapy Surface, Made By Hill-Rom Manufacturing, Inc., Charleston, SC.
The Envision E700 Low Airloss Therapy Surface helps prevent and treat stage III and stage IV pressure Terminated |
IOQ | None listed |
| Sep 21, 2005 | Hill-Rom Manufacturing, Inc. Clinitron At Home Air Fluidized Therapy Bed Terminated |
FNL | K942184 |
| Jul 20, 2004 | Hill-Rom Manufacturing, Inc. Magnum II Bariatric Patient Care System Terminated |
FNL | None listed |
| Oct 24, 2003 | Hill-Rom Manufacturing, Inc. FLEXICAIR MC3 Low Airloss Therapy unit Terminated |
IOQ | None listed |
| Oct 24, 2003 | Hill-Rom Manufacturing, Inc. FLEXICAIR II, Low Airloss Therapy unit.This unit is similar to MC3 but does not have the utility shelf above the foodboard, patient scale or alternate CPR function actuators. Terminated |
IOQ | K863047 |
| Oct 24, 2003 | Hill-Rom Manufacturing, Inc. Clinitron At Home Air Fluidized Therapy Unit Terminated |
INX | K942184 |
| Jul 10, 2003 | Hill-Rom Manufacturing, Inc. CLINITRON UP-LIFT Air Fluidized Therapy unit. Terminated |
INX | K920112 |
| Jul 10, 2003 | Hill-Rom Manufacturing, Inc. CLINITRON CII Air Fluidized Therapy unit. Terminated |
INX | K813584 |