23 results
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21ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Progressa Bed - AC-powered adjustable hospital bed
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·April 18, 2018
PR1000 Pivot Rehab Bed AC powered adjustable bed.
FDA Enforcement
Class II
·Terminated·Med-Mizer, Inc.·September 26, 2018
Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked
FDA Enforcement
Class II
·Ongoing·Convergent Dental·November 29, 2023
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
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
Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty. The S2 Mini Drill System consists of a foot pedal and a drill, with an integrated micromotor, to drive various burs.
FDA Enforcement
Class II
·Ongoing·Bien-Air Surgery Sa·October 28, 2020
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
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
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to HHE for additional details. Component: N/A
FDA Enforcement
Class II
·Ongoing·Intuitive Surgical, Inc.·March 19, 2025
Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and ablation (nitrous oxide release); (2) CryoBalloon Controller contains the cartridge heater and cryogen delivery valve, which is controlled with the foot pedal; (3) Foot Pedal; and (4) CryoBalloon Cartridge containing 36 grams of nitrous oxide.
FDA Enforcement
Class II
·Terminated·PENTAX of America Inc·May 22, 2019
Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and ablation (nitrous oxide release); (2) CryoBalloon Controller contains the cartridge heater and cryogen delivery valve, which is controlled with the foot pedal; (3) Foot Pedal; and (4) CryoBalloon Cartridge containing 36 grams of nitrous oxide.
FDA Enforcement
Class II
·Terminated·PENTAX of America Inc·May 22, 2019
Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and ablation (nitrous oxide release); (2) CryoBalloon Controller contains the cartridge heater and cryogen delivery valve, which is controlled with the foot pedal; (3) Foot Pedal; and (4) CryoBalloon Cartridge containing 36 grams of nitrous oxide.
FDA Enforcement
Class II
·Terminated·PENTAX of America Inc·May 22, 2019
Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical energy to mechanically drive attachment, microsaws, shaver blades and burs, burs and perforator tools for cutting and shaping bone including spine and cranium.
FDA Enforcement
Class II
·Ongoing·Bien-Air Surgery Sa·October 28, 2020
Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology.
FDA Enforcement
Class II
·Ongoing·Bien-Air Surgery Sa·October 28, 2020
NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation of soft tissue. It primarily consists of a reusable console with foot pedal and a disposable handpiece. For the morcellation and removal of tissue during pelviscopic, laparoscopic, percutaneous and open surgical procedures whenever access to the surgical site is limited.
FDA Enforcement
Class II
·Terminated·Nico Corp.·September 23, 2015