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FORCEPS MOSQ HARTMAN CRV SEMI-DISP
JEDMED INSTRUMENT COMPANY
54-5752
In Commercial Distribution
- M6335457520 ()
54-5752
- ENT foreign body extraction forceps
FORCEPS MOSQ HARTMANN STR SEMI-DISP
JEDMED INSTRUMENT COMPANY
54-5750
In Commercial Distribution
- M6335457500 ()
54-5750
- ENT foreign body extraction forceps
FORCEPS ADSON SERR 4-3/4" SEMI DISP
JEDMED INSTRUMENT COMPANY
54-5655
In Commercial Distribution
- M6335456550 ()
54-5655
- ENT foreign body extraction forceps
FORCEPS ADSON 1X2 4-3/4" SEMI-DISP
JEDMED INSTRUMENT COMPANY
54-5650
In Commercial Distribution
- M6335456500 ()
54-5650
- ENT foreign body extraction forceps
FORCEPS ALLIS 4X5 TEETH 6 IN REG WT
JEDMED INSTRUMENT COMPANY
54-5600
In Commercial Distribution
- M6335456000 ()
54-5600
- ENT foreign body extraction forceps
FORCEPS COTTLE COLUMELLA 14MM WIDE
JEDMED INSTRUMENT COMPANY
54-5480
In Commercial Distribution
- M6335454800 ()
54-5480
- ENT foreign body extraction forceps
FORCEPS GOITER LAHEY
JEDMED INSTRUMENT COMPANY
54-5779
In Commercial Distribution
- M6335457790 ()
54-5779
- ENT foreign body extraction forceps
FORCEPS BABCOCK
JEDMED INSTRUMENT COMPANY
54-5775
In Commercial Distribution
- M6335457750 ()
54-5775
- ENT foreign body extraction forceps
SWISS Cilia and Suture Forceps, precision fitted diagonal jaws, 3mm wide, 3 3/4"
BR Surgical, LLC
BR43-42710
In Commercial Distribution
- 00840183504847 ()
BR43-42710
- ENT foreign body extraction forceps
FORCEPS ALLIGATOR GREVEN
Bausch & Lomb Incorporated
X0244
In Commercial Distribution
- 00757770433971 ()
X0244
- ENT foreign body extraction forceps
FORCEPS CUSHING BAYONET 8.0IN
Bausch & Lomb Incorporated
P0525
In Commercial Distribution
- 00757770429646 ()
P0525
- ENT foreign body extraction forceps
FORCEPS CRIMPER SCHEER
Bausch & Lomb Incorporated
N1709 25
In Commercial Distribution
- 00757770415526 ()
N1709 25
- ENT foreign body extraction forceps
STORZ MINIATURE EAR FRCP 3.5MM
Bausch & Lomb Incorporated
X0241 A
In Commercial Distribution
- 00757770421480 ()
X0241 A
- ENT foreign body extraction forceps
An application software program intended to extract, process, and store non-clinical processing data (e.g., log of equipment usage, equipment status) from medical equipment to assist process management. It is not intended for control of equipment
NEUROLIEF LTD
RLV-PMI-102
In Commercial Distribution
- 07290018393147 ()
- Configurable electronic form web-based application software
No Description
TYMPA HEALTH TECHNOLOGIES LIMITED
iOS
In Commercial Distribution
- 25060753520070 ()
- Video otoscope/audiometer
The Diary is a mobile app intended for use by people with diabetes, in order to log, track and share blood glucose levels, insulin delivery, physical activity, as well as carbs and meal information as part of the endo.digital Platform used by their healthcare provider. Diary also enables people to communicate with their healthcare provider.
The Diary mobile app also enables the patient to see their insulin treatment recommendations provided by their healthcare provider. The insulin treatment plan is approved by your healthcare provider and he/she may have been assisted by the endo.digital algorithm before approving the plan.
The Diary Mobile app is suited for both iPhone and Android users.
The Bolus Calculator, a component of the DreaMed Diary App, is a diabetes management tool for people with type 1 diabetes above the age of 6 and type 2 diabetes above
the age of 10, who use subcutaneous insulin injections therapy (not for pump use). This tool can help calculate their rapid acting analogs for insulin bolus doses based on user-entered blood glucose and/or meal information.
The initial setup of the user’s treatment plans, and bolus calculator settings must be performed by a healthcare provider.
DREAMED DIABETES LTD
02.XX.YY
In Commercial Distribution
- 07290017735030 ()
N/A
- Clinical management support software
A Windows based desktop widget application that can be connected to the laptop’s webcam, the Orpheus GATE or a USB connected camera.
It is useful also to drag images from a USB connected camera/smartphone or from the PC/Laptop directory and upload to the Orpheus System.
For example: discharge workflow in which clinicians record a video session with the patient explaining their care path and requirements after discharge.
ORPHEUS MEDICAL LTD
01
In Commercial Distribution
- 07290017025094 ()
MAU-EG20004
- Radiology information system application software
Dream Sock Software App.
The Dream Sock is intended for over-the-counter (OTC) use only in a home environment. It is not
intended to provide notification for every episode of the unexpected occurrences of elevated or
depressed PR or a low SpO2 level; rather, the Dream Sock is intended to provide a notification only
when sufficient data are available for analysis. The notifications and associated data can be used to
supplement the decision by caregivers to seek additional guidance for medical care of the infant. The
Dream Sock is not intended to replace traditional methods of monitoring, diagnosis or treatment.
Owlet Baby Care, Inc.
3.0
In Commercial Distribution
- 00810099090819 ()
- Multiple vital physiological parameter monitoring system, home-use
The Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist-wearable devices to create, record, store, transfer, and display a single channel electrocardiogram (ECG) qualitatively similar to a Lead I ECG. The Fitbit ECG App determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The AF detection function is not recommended for users with other known arrhythmias.
The Fitbit ECG App is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG Spot Check is
intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment. The Fitbit ECG App is not intended for use by people under 22 years old
FITBIT, INC.
FB603
In Commercial Distribution
- 00810038851983 ()
- Cardiopulmonary physiological parameter analysis software
No Description
Thought Technology Ltd.
SA9030
In Commercial Distribution
- 07540191000586 ()
- Psychophysiological biofeedback system
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Perineal orifice incontinence-control electrical stimulation system probe, reusable
No Description
Thought Technology Ltd.
SA9013
In Commercial Distribution
- 07540191000548 ()
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Psychophysiological biofeedback system
- Perineal orifice incontinence-control electrical stimulation system, professional
No Description
Thought Technology Ltd.
SA4502
In Commercial Distribution
- 07540191000487 ()
- Psychophysiological biofeedback system
No Description
Sonova AG
088-0021
In Commercial Distribution
- 07613389543254 ()
- Audiometric/hearing device software
The Progressive Orthodontics App is an orthodontic appliance design and treatment simulation software. This software is
for use by dental professionals in a healthcare facility to assist in diagnosis and design solutions for patients. Digital scans
(3D) of a patient’s dentition can be loaded into the software and the dental professional can then review different treatment
plans and simulations for each individual patient and decide on the most appropriate treatment.
PROGRESSIVE AMERICA, INC.
2.0
In Commercial Distribution
- D16420251 ()
- CAD/CAM software
The Progressive Orthodontics App is an orthodontic appliance design and treatment simulation software. This software is
for use by dental professionals in a healthcare facility to assist in diagnosis and design solutions for patients. Digital scans
(3D) of a patient’s dentition can be loaded into the software and the dental professional can then review different treatment
plans and simulations for each individual patient and decide on the most appropriate treatment.
PROGRESSIVE AMERICA, INC.
0.9.6
In Commercial Distribution
- D16409625 ()
- CAD/CAM software
No Description
Get-Grin Inc.
Initial Release
In Commercial Distribution
- D962GGAR0003 ()
- Radiological PACS software
No Description
Get-Grin Inc.
W Version
In Commercial Distribution
- D962GGAW0002 ()
- Radiological PACS software
myCordella Patient App is a component of the myCordella Patient Kit.
myCordella Patient App is an intuitive, user-friendly software that assists patients with obtaining vital sign measurements.
• Collects & securely transmits daily health information to clinicians
• Facilitates review of past measurements
• Allows secure communication between patient and clinician
Endotronix, Inc.
100256-02
In Commercial Distribution
- 00850008997037 ()
- Bedside monitor remote-viewing software, physiological parameter
Jacoti Listen App 2.X
Jacoti
Jacoti Listen App 2.X
In Commercial Distribution
- 05407004250014 ()
- Air-conduction hearing aid, wearable case
MapRT is used to assist treatment planning whereby the patient surface and positioning devices captured at simulation can be modelled against the treatment devices, such that any potential collisions can be predicted.
VISION RT LIMITED
MapRT Web app 1.1
In Commercial Distribution
- 05056190500887 ()
MapRT Web app
- Radiation therapy software
MapRT is used to assist treatment planning whereby the patient surface and positioning devices captured at simulation can be modelled against the treatment devices, such that any potential collisions can be predicted.
VISION RT LIMITED
MapRT Web app
In Commercial Distribution
- 05056190500771 ()
MapRT Web app
- Radiation therapy software
No Description
Cochlear Bone Anchored Solutions AB
P1646035
In Commercial Distribution
- 09321502053006 ()
P1646035
- Audiometric/hearing device software
No Description
Cochlear Bone Anchored Solutions AB
P1646054
In Commercial Distribution
- 09321502052993 ()
P1646054
- Audiometric/hearing device software
No Description
Brainlab AG
1.2
In Commercial Distribution
- 04056481145385 ()
- Multidisciplinary medical image management software
No Description
Carl Zeiss Meditec AG
FORUM Viewer App
In Commercial Distribution
- 04049471100020 ()
- Patient health record information system application software
DreamMapper iOS NA Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution
- 00606959051331 ()
1101478
- Self-care monitoring/reporting software
DreamMapper iOS NA Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution
- 00606959049932 ()
1101478
- Self-care monitoring/reporting software
DreamMapper iOS NA Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution
- 00606959049086 ()
1101478
- Self-care monitoring/reporting software
No Description
Brainlab AG
1.1
Not in Commercial Distribution
- 04056481144265 ()
- Multidisciplinary medical image management software
physIQ Medical Device Data System Android App
PHYSIQ, INC
3.4 (Edison)
In Commercial Distribution
- 00860004366218 ()
- Electrocardiography telemetric monitoring system