39 results
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20ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Bari Maxx II, KCI''s BariMaxx II bariatric bed, P/N 310611, November 2001, KCI The Clinical Advantage, P. O. Box 659508, San Antonio, Texas 78265-9508, Call Toll Free 1-800-531-5346, FAX (210) 308-3998, Http://www.kci1.com
FDA Recall
Terminated
·Kinetic Concepts, Inc·Product code FNL·August 16, 2004
Progressa Bed - AC-powered adjustable hospital bed
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code FNL·January 12, 2018
PR1000 Pivot Rehab Bed AC powered adjustable bed.
FDA Recall
Terminated
·Med-Mizer, Inc.·Product code FNL·July 25, 2018
KayserBetten model IDA beds Product Usage: BED, AC-POWERED ADJUSTABLE HOSPITAL
FDA Recall
Terminated
·mobility unlimited inc·Product code FNL·April 11, 2013
Progressa Bed - AC-powered adjustable hospital bed
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·April 18, 2018
3.0mm 45 Degree Beval with cable Product Number AC2430-01 is an ablation wand
FDA Recall
Terminated
·Innovatech Medical Resources L.P.·Product code GEI·August 8, 2011
PR1000 Pivot Rehab Bed AC powered adjustable bed.
FDA Enforcement
Class II
·Terminated·Med-Mizer, Inc.·September 26, 2018
Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndiGo modules (retrofit kits) that can be installed on Citadel (model no. INDIDAA) or Enterprise (model no. INDIJAA) beds manufactured without IndiGo modules assembled at the time of manufacturing and subsequently retrofitted on the beds.
FDA Enforcement
Class II
·Terminated·ARJOHUNTLEIGH POLSKA Sp. z.o.o.·October 6, 2021
Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov, Sweden; Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800 General medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care and oncology. The bed is appropriate for high dependency patients who pose a movement and handling risk and/or whose clinical condition requires that they are positioned with the minimal physical handling.
FDA Enforcement
Class II
·Terminated·Arjo, Inc. dba ArjoHuntleigh·August 14, 2013
Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in electronic weigh scale, patient bed exit alarm, and under bed anti-entrapment system; ArjoHuntleigh AB, Eslov, Sweden; Models 9000, 9600, 9700 and 9800 General medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care and oncology. The bed is appropriate for high dependency patients who pose a movement and handling risk and/or whose clinical condition requires that they are positioned with the minimal physical handling.
FDA Enforcement
Class II
·Terminated·Arjo, Inc. dba ArjoHuntleigh·August 14, 2013
Low-Boy Bed, AC-powered adjustable hospital bed with a low position of 7'' to a high position of 30''. The beds are distributed by SIZEWise Rentals, Ellis, KS.
FDA Recall
Terminated
·Rayes Inc·Product code FNL·November 14, 2005
KayserBetten model IDA beds Product Usage: BED, AC-POWERED ADJUSTABLE HOSPITAL
FDA Enforcement
Class II
·Terminated·mobility unlimited inc·December 25, 2013
TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible mattress The TotalCare Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·July 31, 2013
Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation.
FDA Enforcement
Class II
·Terminated·Aesculap, Inc.·March 6, 2013
Nihon Kohden Electric Stimulator, Model number: MS-210BK (Optional accessories of MEB-2200A -Neuropack Evoked Potential and EMG Measuring System)
FDA Recall
Terminated
·Nihon Kohden America Inc·Product code GWF·August 23, 2006
ANSPACH***eMax2 Lower Profile Foot Pedal***Rx Only*** This device is intended to be used with Anspach Systems
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·July 2, 2014
SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. Product Usage: The use of the SMART ABLATE Generator and all accessories is indicated in combination with compatible therapeutic catheters for use in conventional intracardiac RF ablation procedures. The SMARTABLATE Foot Pedal is designed to initiate or discontinue operation of the SMARTABLATE System. The Foot Pedal can be connected to the SMARTABLATE RF Generator, SMARTABLATE Irrigation Pump; or SMARTABLATE Remote Control.
FDA Enforcement
Class II
·Terminated·Biosense Webster, Inc.·June 3, 2015
Access Point Medical-Heavy Duty Rollator (rolling walker), Product Code RL12010HD, with seat, backrest, 8'' wheels with locks, maximum capacity 400 lbs.,and wire basket. Manufactured for Access Point Medical, St. Louis, MO. Made in China
FDA Recall
Terminated
·Access Point Medical LLC
Three City Place Drive
Suite 750
St. Louis MO 63141·Product code ITJ·June 20, 2006
Access Point Medical-Heavy Duty Rollator with Curved Back (rolling walker), Product Code RL12011, with seat, curved backrest, 8'' wheels with locks, maximum capacity 400 lbs.,and wire basket. Manufactured for Access Point Medical, St. Louis, MO. Made in China
FDA Recall
Terminated
·Access Point Medical LLC
Three City Place Drive
Suite 750
St. Louis MO 63141·Product code ITJ·June 20, 2006
ANSPACH***REF 98-0034***Custom XMax Motor, Pneumatic with Hand Control and Custom Autolube III IRR Foot Pedal***Rx Only*** This device is intended to be used with Anspach Systems
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·July 2, 2014