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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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EQTXHS010 SAT13
MAQUET SAS
ARDSAT239018A
Not in Commercial Distribution

  • 03700712416119 ()


  • Medical monitor/light mount
EQTXHS021 SAT13
MAQUET SAS
ARDSAT239020A
Not in Commercial Distribution

  • 03700712416102 ()


  • Medical monitor/light mount
EQTXHS021 SAT12
MAQUET SAS
ARDSAT239019A
Not in Commercial Distribution

  • 03700712416096 ()


  • Medical monitor/light mount
EQTXHS010 11
MAQUET SAS
ARDEQT239017A
Not in Commercial Distribution

  • 03700712416072 ()


  • Medical monitor/light mount
EQTXHS021 11
MAQUET SAS
ARDEQT239018A
Not in Commercial Distribution

  • 03700712416065 ()


  • Medical monitor/light mount
PWDII70DF AIM CL K3 11
MAQUET SAS
ARDPWT209151A
Not in Commercial Distribution

  • 03700712416034 ()


  • Operating room light
PWDII50DF AIM CL K3 11
MAQUET SAS
ARDPWT209152A
Not in Commercial Distribution

  • 03700712416027 ()


  • Operating room light
PWDII50DF AIM XHS010 K4 1011
MAQUET SAS
ARDPWT239282A
Not in Commercial Distribution

  • 03700712416010 ()


  • Operating room light
OHDII FHD QL AIR03 U
MAQUET SAS
ARD568803952
In Commercial Distribution

  • 03700712415976 ()


  • Surgical video camera
OHDII AIR03 QL FHD E
MAQUET SAS
ARD568803951
In Commercial Distribution

  • 03700712415969 ()


  • Surgical video camera
LCA 40 MOBILE
MAQUET SAS
ARDLCA309009A
In Commercial Distribution

  • 03700712415938 ()


  • Mobile examination/treatment room light
LCA 10 MOBILE
MAQUET SAS
ARDLCA309008A
In Commercial Distribution

  • 03700712415921 ()


  • Mobile examination/treatment room light
LCA 40
MAQUET SAS
ARDLCA209021A
In Commercial Distribution

  • 03700712415877 ()


  • Fixed examination/treatment room light
LCA 40 WALL
MAQUET SAS
ARDLCA109001A
In Commercial Distribution

  • 03700712415860 ()


  • Fixed examination/treatment room light
A mobile workstation composed by a central unit with ultrasound beamformer, a tactile screen, a mouse, a touch pen and a footswitch. All these components are assembled on a mobile cart, Optionally a keyboard can be delivered and a trackball mouse can be delivered instead of the mouse.
KOELIS
KURO3000-2
Not in Commercial Distribution

  • 03665134000547 ()
  • 03665134000035 ()
  • 03665134000554 ()


  • General-purpose ultrasound imaging system
Nasal Wash. Nose drug administration device intended specifically to administer medicinal substances or saline solutions to treat nose
FLAEM NUOVA SPA
P0709EM
In Commercial Distribution

  • 08018294012793 ()
DR12P00

  • Nasal irrigation set, home-use
Non Contact Infrared Body Thermometer
Hetaida Technology Co., Ltd
HTD8813C
Not in Commercial Distribution

  • 17958909771661 ()
  • 07958909771664 ()


  • Infrared patient thermometer, skin
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution

  • 00935712300004 ()
MXU-RV01

  • Mobile basic diagnostic x-ray system, digital
The g.Estim FES is a programmable constant-current stimulator that can deliver electrical pulses with alternating polarities, lengths, amplitudes as well as trains of such pulses. The applied part is galvanic isolated. The stimulator is powered by a combination of USB bus-power and battery power. The host computer must use Microsoft Windows. The stimulator is controlled via a software API that uses a USB connection. A host application can be situated on top of the API and can control the stimulator.
g.tec medical engineering GmbH
TD 1.x
In Commercial Distribution

  • EBCI11700 ()
1170

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
g.Estim PRO is a constant current, biphasic electrical stimulator intended for stimulation of neural tissue. g.Estim PRO has an applied part of type BF with connectors for bipolar stimulation electrodes (anode and cathode). The device is controlled by a computer via USB connection. It also has digital outputs for synchronization with other devices. A hand-switch allows you to perform stimulation manually. Alternatively, a foot-switch can be used to explicitly enable/disable stimulation.
g.tec medical engineering GmbH
1
In Commercial Distribution

  • EBCI11500 ()
1150

  • Cortical electrode
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
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