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The Wi-3 Arm is used to fix the outer (white) HAL-RAR sleeve in place to enhance gradual opening of the RAR window when mucopexy is performed, allowing the surgeon, the nurse or any assistant to comfortably hold the system in position.
The Wi-3 HAL-RAR System (HAL - Hemorrhoidal Artery Ligation, RAR - Recto Anal Repair) is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, to manually ligate these arteries (HAL), and subsequently carry out a mucopexy of hemorrhoidal tissue prolapse (RAR) if necessary.
AMI Agency for Medical Innovations GmbH
TRI2070
In Commercial Distribution
- EAMITRI20700 ()
TRI2070
- Noninvasive vascular ultrasound system
Electronic unit for identifying the localised haemorrhoidal arteries by means of acoustic signals. Part of the Wi-3 HAL-RAR System.
The Wi-3 HAL-RAR System (HAL - Hemorrhoidal Artery Ligation, RAR - Recto Anal Repair) is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, to manually ligate these arteries (HAL), and subsequently carry out a mucopexy of hemorrhoidal tissue prolapse (RAR) if necessary.
AMI Agency for Medical Innovations GmbH
TRI2010
Not in Commercial Distribution
- EAMITRI20100 ()
- Height: 7 Centimeter
- Outer Diameter: 23 Centimeter
TRI2010
- Noninvasive vascular ultrasound system
Needle holder for use during haemorrhoidal artery ligation.
AMI Agency for Medical Innovations GmbH
AHN 006
In Commercial Distribution
- EAMIAHN0060 ()
AHN 006
- Suturing needle holder, reusable
Codman® CereLink® ICP Monitor
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
826820
In Commercial Distribution
- 10381780533788 ()
826820
- Intracranial pressure monitor
Codman® CereLink® Replacement Battery
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
826824
In Commercial Distribution
- 10381780533771 ()
82-6824
- Intracranial pressure monitor
Codman® CereLink® Replacement Power Supply
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
826822
In Commercial Distribution
- 10381780533764 ()
826822
- Intracranial pressure monitor
CODMAN® VPV System
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
823192R
In Commercial Distribution
- 10381780519348 ()
82-3192R
- Cerebrospinal fluid shunt valve programmer
CODMAN® HAKIM® Valve Programmer
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
823190R
In Commercial Distribution
- 10381780519317 ()
82-3190R
- Cerebrospinal fluid shunt valve programmer
Upper arm blood pressure monitor.
BODYTRACE, INC
BT104O
In Commercial Distribution
- B726BT104O2 ()
- B726BT104O1 ()
- B726BT104O0 ()
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Upper arm blood pressure monitor.
BODYTRACE, INC
BT104
In Commercial Distribution
- B726BT1042 ()
- B726BT1041 ()
- B726BT1040 ()
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
The Powered Breast Pump is intended to express and collect the breast milk of a nursing woman for the purpose of feeding the collected milk to a baby.
LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SANAYI TICARET LTD STI
Smartpump 3.0 Double Electric Breast Pump
In Commercial Distribution
- 60044677533517 ()
- 00044677533515 ()
53351
- Breast pump, electric
The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.
The non-invasive blood pressure tracking is based on Pulse Arrival Time (PAT) which is obtained utilizing ECG and PPG signals, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment.
VMS can also generate alerts when cardiac arrhythmias (Tachycardia, Bradycardia, Asystole, Ventricular Tachycardia/Ventricular Fibrillation and Atrial Fibrillation/Atrial Flutter) are detected.
The ECG rhythm analysis is intended for use by medically qualified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmia and medical interventions.
The VMS Adapter and Chest Sensor are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
L2050G Adapter
In Commercial Distribution
- B595L2050G0 ()
L2050G
- Cardiac arrhythmia monitoring system
- Wearable multiple vital physiological parameter monitoring system
The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.
The non-invasive blood pressure tracking is based on Pulse Arrival Time (PAT) which is obtained utilizing ECG and PPG signals, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment.
VMS can also generate alerts when cardiac arrhythmias (Tachycardia, Bradycardia, Asystole, Ventricular Tachycardia/Ventricular Fibrillation and Atrial Fibrillation/Atrial Flutter) are detected.
The ECG rhythm analysis is intended for use by medically qualified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmia and medical interventions.
The VMS Adapter and Chest Sensor are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
CS2050 Chest Sensor
In Commercial Distribution
- B595CS20500 ()
- B595L2050G1 ()
CS2050
- Cardiac arrhythmia monitoring system
- Wearable multiple vital physiological parameter monitoring system
Cutter Driver for Plaque Excision Systems
Covidien LP
FG02550
In Commercial Distribution
- 00821684043318 ()
- Mechanical atherectomy system catheter, peripheral
The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.
The non-invasive blood pressure tracking is based on Pulse Arrival Time (PAT) which is obtained utilizing ECG and PPG signals, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment.
VMS can also generate alerts when cardiac arrhythmias (Tachycardia, Bradycardia, Asystole, Ventricular Tachycardia/Ventricular Fibrillation and Atrial Fibrillation/Atrial Flutter) are detected.
The ECG rhythm analysis is intended for use by medically qualified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmia and medical interventions.
The VMS Adapter and Chest Sensor are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
L2050R Pulse Oximetry Sensor
In Commercial Distribution
- B595L2050R0 ()
- B595L2050R1 ()
- B595L2050R2 ()
L2050R
- Pulse oximeter probe, reusable
- Pulse Co-oximeter probe, reusable
Ultrasonic Generator replacement for Generator BoneWelder 150-W1
Surgical Fusion Technologies GmbH
SupraFuser B Generator
Not in Commercial Distribution
- 07649990202204 ()
SF04-005-B
- Ultrasonic surgical system generator
No Description
Surgical Fusion Technologies GmbH
BoneWelder 150-W1
Not in Commercial Distribution
- 07649990202150 ()
BW04-001
- Ultrasonic surgical system generator
No Description
Surgical Fusion Technologies GmbH
SupraFuser Generator
In Commercial Distribution
- 07649990202075 ()
SF04-005
- Ultrasonic surgical system generator
No Description
SurgicEye GmbH
declipseSPECT Viewer
In Commercial Distribution
- ESURSE13010002 ()
SE 1301-0002
- Scintillation radiation measuring probe
The Digital Intra-Oral X-Ray Imaging System is used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination and the diagnosis of structural diseases. The product is expected to be used in hospitals and clinics, operated and used by trained professionals under the guidance of doctors.
CEFLA SOCIETA' COOPERATIVA
X-VS E
In Commercial Distribution
- 08033837936855 ()
- Dental digital imaging sensor, intraoral