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STEM, HIP, LONG REVELATION V2, 8 R POROUS COATED P2
Encore Medical, L.P.
427-40-080
In Commercial Distribution
- 00888912080781 ()
- Coated hip femur prosthesis, modular
STEM, HIP, LONG REVELATION V2, 12 L POROUS COATED P2
Encore Medical, L.P.
427-30-120
In Commercial Distribution
- 00888912080408 ()
- Coated hip femur prosthesis, modular
STEM, HIP, LONG REVELATION V2, 9 L POROUS COATED P2
Encore Medical, L.P.
427-30-090
In Commercial Distribution
- 00888912080385 ()
- Coated hip femur prosthesis, modular
INSERT, FOR 2.0 MINI TRAUMA, MIDFACE, CAPITOL HEALTH SYSTEM, V2
KLS-Martin L.P.
55-964-94-04
In Commercial Distribution
- 00888118088482 ()
- Surgical instrument/implant rack
Dental Ultrasonic Scaler
Guilin Woodpecker Medical Instrument Co., Ltd.
V2 LED
In Commercial Distribution
- 06944843601649 ()
- Ultrasonic dental scaling/debridement system
Ultrasonic Scalers
Guilin Woodpecker Medical Instrument Co., Ltd.
V2 LED
In Commercial Distribution
- 06944843600130 ()
- Ultrasonic dental scaling/debridement system
StrokeSENS LVO is a radiological computer-aided triage and notification (CADt) software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (L VO) in head CTA images.
StrokeSENS LVO uses a software algorithm to identify suspected LVO findings. In the case of a suspected L VO, the system will send a notification to a pre-configured destination(s), notifying the clinicians of the existence of a suspected LVO that requires review. The notification system is intended to be used in parallel to the standard of care workflow to notify clinicians of the existence of the case earlier that they may have been notified as part of the standard of care workflow.
Notifications may include a compressed preview of images. Notifications are meant for informational purposes only and are not intended for diagnostic use beyond notification. The StrokeSENS LVO device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of StrokeSENS LVO are intended to be used in conjunction with other patient information and based on professional judgement, to assist with triage/ prioritization of medical images. Notified clinicians are responsible for viewing full images per standard of care.
Circle Cardiovascular Imaging Inc
v2.x
- CT system application software
ViewBladder 10 SeeMore 4.2.x
INTERSON CORP
ViewBladder10 V2
In Commercial Distribution
- 00850921007240 ()
99-9008
- Extracorporeal ultrasound imaging transducer, hand-held
QAWeb Enterprise Web Client
Barco NV
V2.xx
In Commercial Distribution
- 05415334002449 ()
K5402901
- Radiology workstation display quality assurance software
QAWeb Enterprise Agent
Barco NV
V2.xx
In Commercial Distribution
- 05415334002432 ()
K5402921
- Radiology workstation display quality assurance software
The NObreath® is a portable, non-invasive device for the measurement of Fractional Exhaled Nitric Oxide (FeNO) in human breath. The production of nitric oxide is often found to be increased in inflammatory conditions such as asthma. Measurement of FeNO by NObreath® is a method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy, as an indication of the therapeutic effect in patients with elevated FeNO levels.
The fractional NO concentration in expired breath (FeNO), can be measured by NObreath® according to guidelines for NO measurement established by the American Thoracic Society.
NObreath® is intended for children, 7- 17 years, and adults 18 years and older. NObreath® 12 second test mode is for age 7 and up
NObreath® 10 second test mode is for ages 7-10 only who cannot successfully complete a 12 second test.
FeNO measurements provide the physician with means of evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to the established clinical and laboratory assessments in asthma. The NObreath® cannot be used with infants or by children under the age of 7 as measurement requires patient cooperation.
NObreath® should not be used in critical care, emergency care or in anesthesiology.
BEDFONT SCIENTIFIC LIMITED
NOBreath V2
In Commercial Distribution
- 05060246860177 ()
NOBREATH-V2
- Nitric oxide breath analyser
Forehead and Ear Infrared Thermometer - Upgraded Firmware
KONQUEST GROUP INC
KDT-2106 V2
In Commercial Distribution
- 00869378000421 ()
- Infrared patient thermometer, ear
illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, image manipulation, communication and storage. illumeo is offering a primary interpretation solution for reviewing and analysing a large variety of medical images deriving from various imaging modalities as well as non-imaging information. illumeo integrates with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.
Philips Medical Systems Nederland B.V.
v2.x
In Commercial Distribution
- 00884838087958 ()
45980141116X
- Radiology picture archiving and communication system workstation
Tuning Device
OTTO BOCK HEALTHCARE
560X11=V2
- Portable computer
This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
FUJIFILM CORPORATION
EC-530LS V2
In Commercial Distribution
- 04547410341294 ()
- Flexible video colonoscope, reusable
This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
FUJIFILM CORPORATION
EC-530HL V2
In Commercial Distribution
- 04547410341287 ()
- Flexible video colonoscope, reusable
The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
FUJIFILM CORPORATION
EG-600WR v2
In Commercial Distribution
- 04547410337402 ()
- 14547410337409 ()
- Flexible video gastroduodenoscope
This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
FUJIFILM CORPORATION
EC-600WL v2
In Commercial Distribution
- 04547410337396 ()
- 14547410337393 ()
- Flexible video colonoscope, reusable
Vasculitis Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4 V2
In Commercial Distribution
- 00847865002394 ()
- 1 Each
6651870D
- Multiple vasculitis-associated antibody IVD, kit, multiplex
EBV IgG Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4 V2
In Commercial Distribution
- 00847865002226 ()
- 1 Each
6651270C
- Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
- Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
- Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay