ClearanceBrief
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

CodeDeviceRecords
IOQBed, Flotation Therapy, Powered7
INXBed, Air Fluidized5
FNMMattress, Air Flotation, Alternating Pressure4
HGMSystem, Monitoring, Perinatal3
FNLBed, Ac-Powered Adjustable Hospital2
BYIPercussor, Powered-Electric1
CBKVentilator, Continuous, Facility Use1
FMZIncubator, Neonatal1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Apr 9, 2008K080226NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912
Hill-Rom Manufacturing, Inc.
HGM
Oct 8, 2003K032772MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM
Hill-Rom Manufacturing, Inc.
HGM
Aug 1, 2003K031387ISOLETTE INFANT INCUBATOR, MODEL C2000E
Hill-Rom Manufacturing, Inc.
FMZ
Jan 11, 2002K014094MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM
Hill-Rom Manufacturing, Inc.
HGM

Latest recalls

DateFirm and productCodeLinked 510(k)
Nov 12, 2020Hill-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
CBKK170037
Sep 15, 2017HILL-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
BYIK163378
Feb 15, 2011Hill-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
IOQK863047
Feb 15, 2011Hill-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
IOQK863047
Aug 25, 2009Hill-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
INXK920112
Aug 25, 2009Hill-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
INXK813584
Aug 3, 2009Hill-Rom Manufacturing, Inc.
Flexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores.
Terminated
IOQK863047
Aug 3, 2009Hill-Rom Manufacturing, Inc.
Flexicair II (model 13000) Low Airloss Therapy Units, for the prevention of pressure sores.
Terminated
IOQK863047
Jan 7, 2009Hill-Rom Manufacturing, Inc.
Pro 2000, Alternating Pressure Air Flotation Mattress, Model number 5613 Designed to provide enhanced static and pulsation pressure relieving therapies.
Terminated
FNMNone listed
Jan 7, 2009Hill-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
FNMNone listed
Jan 7, 2009Hill-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
FNMNone listed
Jan 7, 2009Hill-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
FNMNone listed
Oct 7, 2008Hill-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
IOQNone listed
Sep 21, 2005Hill-Rom Manufacturing, Inc.
Clinitron At Home Air Fluidized Therapy Bed
Terminated
FNLK942184
Jul 20, 2004Hill-Rom Manufacturing, Inc.
Magnum II Bariatric Patient Care System
Terminated
FNLNone listed
Oct 24, 2003Hill-Rom Manufacturing, Inc.
FLEXICAIR MC3 Low Airloss Therapy unit
Terminated
IOQNone listed
Oct 24, 2003Hill-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
IOQK863047
Oct 24, 2003Hill-Rom Manufacturing, Inc.
Clinitron At Home Air Fluidized Therapy Unit
Terminated
INXK942184
Jul 10, 2003Hill-Rom Manufacturing, Inc.
CLINITRON UP-LIFT Air Fluidized Therapy unit.
Terminated
INXK920112
Jul 10, 2003Hill-Rom Manufacturing, Inc.
CLINITRON CII Air Fluidized Therapy unit.
Terminated
INXK813584
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