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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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
Windows PC Application for use with Eko products.
Eko Devices, Inc.
1.2.4
In Commercial Distribution

  • 00863609000358 ()


  • Medical equipment clinical data interfacing software
No Description
Garmin International, Inc.
1.x
In Commercial Distribution

  • 00860009117716 ()


  • Cardiopulmonary physiological parameter analysis software
No Description
Garmin International, Inc.
1.x
In Commercial Distribution

  • 00860009117709 ()


  • Cardiopulmonary physiological parameter analysis software
This is an application intended to be used by neurologists who are monitoring or reviewing EEGs. It is part of a larger system provided by Persyst.
Persyst Development Corp
App for Web
Not in Commercial Distribution

  • 00869732000142 ()


  • Bioelectrical signal analysis software
The Persyst Mobile App is a software application that can be executed on a mobile platform. It is capable of displaying the original EEG data, and quantitative analysis of EEG data generated by the Persyst EEG Review and Analysis Software. This Mobile App is intended to be used by qualified medical practitioners who will exercise professional judgement in using the information.
Persyst Development Corp
Persyst Mobile App
In Commercial Distribution

  • 00869732000135 ()


  • Bioelectrical signal analysis software
No Description
Ventric Health
VA 1.0
In Commercial Distribution

  • 00850044849024 ()


  • Cardiac mapping system application software
No Description
ECENTIAL ROBOTICS
L60018
In Commercial Distribution

  • 03701311501497 ()


  • Robotic surgical navigation system application software
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ. The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing a Windows platform.
SPAULDING MEDICAL
3.0.6.1
In Commercial Distribution

  • B441SMWINCLIENTAPP0 ()
SMWINCLIENTAPP

  • Electrocardiographic long-term ambulatory recording analyser application software
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ. The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing an IOS platform.
SPAULDING MEDICAL
1.3.6.1
In Commercial Distribution

  • B441SMIOSCLIENTAPP0 ()
SMIOSCLIENTAPP

  • Electrocardiographic long-term ambulatory recording analyser application software
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ. The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing an Android platform.
SPAULDING MEDICAL
1.2.6.1
In Commercial Distribution

  • B441SMANDCLIENTAPP0 ()
SMANDCLIENTAPP

  • Electrocardiographic long-term ambulatory recording analyser application software
A mobile companion app for Bose® Hear products
BOSE CORPORATION
865924-0010
Not in Commercial Distribution

  • 00017817831918 ()


  • Air-conduction hearing aid, receiver-in-canal
Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM@Home mobile application, as accessory of the Subject device. It allows to monitor the user and guide rehabilitation and training through specific protocols.
NCS LAB SRL
SPM01A2
In Commercial Distribution

  • 08051122040933 ()
SPM01A2

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
SW, EXE, Lifeline Response Smart Phone Application, Google
Lifeline Systems Company
300000161331
Not in Commercial Distribution

  • 00884838082137 ()
mSafe

  • Vulnerable patient home alert system
No Description
Nox Medical ehf.
NOX-NOXTURNAL_US_APP
In Commercial Distribution

  • 15694311111665 ()


  • Sleep disorder interpretive software, professional-only
HOW Wire Grasping Pliers, 5 1/2", (140 mm), non-sterile, reusable
Aesculap AG
DP393R
In Commercial Distribution

  • 04038653038183 ()
DP393R

  • Orthodontic pliers
HOW Wire Grasping Pliers, 5 3/4", (145 mm), non-sterile, reusable
Aesculap AG
DP390R
In Commercial Distribution

  • 04038653038176 ()
DP390R

  • Orthodontic pliers
3M™ Unitek™ How Utility Offset Pliers, 801-701, 1/Ea
3M UNITEK CORPORATION
801-707
In Commercial Distribution

  • 00652221217820 ()
801-707

  • Orthodontic pliers
Ligature pliers HOW Crovana 14 cm Fig. 111, curved BOX LOCK
A. Schweickhardt GmbH & Co. KG
5305
In Commercial Distribution

  • E89653050 ()
5305

  • Wire holding/twisting pliers
Ligature pliers HOW Crovana 14 cm Fig. 110, straight BOX LOCK
A. Schweickhardt GmbH & Co. KG
5304
In Commercial Distribution

  • E89653040 ()
5304

  • Wire holding/twisting pliers
The Dario LC Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The Dario LC meter is connected to a SMD through an Apple Lightning® connector in order to provide the glucose meter with power. The SMD also provides an external display for the user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario LC glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform. (DI# 00850065006154) The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.(DI#00850065006178)
LABSTYLE INNOVATION LTD
1147-05
In Commercial Distribution

  • 00850065006253 ()


  • Glucose IVD, kit, enzyme spectrophotometry, rapid
  • Glucose monitoring system IVD, home-use
To be attached at the tube saw to provide the required torque to saw the bone.
OSTEOTEC LIMITED
OST-CBG-15
In Commercial Distribution

  • 05060183095694 ()
OST-CBG-15

  • Surgical instrument handle, non-torque-limiting
No Description
PARKS MEDICAL ELECTRONICS, INC.
811-BTS 24V (F)
In Commercial Distribution

  • 00816787020342 ()


  • Laser Doppler blood flowmeter
No Description
PARKS MEDICAL ELECTRONICS, INC.
811-BL 24V NV
In Commercial Distribution

  • 00816787020328 ()


  • Laser Doppler blood flowmeter
No Description
PARKS MEDICAL ELECTRONICS, INC.
811-BL 24V 901C
In Commercial Distribution

  • 00816787020311 ()


  • Laser Doppler blood flowmeter
No Description
PARKS MEDICAL ELECTRONICS, INC.
811-BL 24V 800C
In Commercial Distribution

  • 00816787020298 ()


  • Laser Doppler blood flowmeter
No Description
BLINK MEDICAL LIMITED
76-0073
In Commercial Distribution

  • 05060745557127 ()
  • 05060745557110 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
FRANCIS FOREIGN BODY ANGLED FLAG SHAPED TIP
SONTEC INSTRUMENTS, INC.
11-3750
In Commercial Distribution

  • 00192896012608 ()
11-3750

  • Eye spud
Double Ended Foreign Body Spud
AURORA SURGICAL, LLC
AS4-026
In Commercial Distribution

  • 08175700114066 ()
AS4-026

  • Ophthalmic surgical probe, reusable
Smart Spirometer and Oximeter connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Spirobank Oxi
In Commercial Distribution

  • 08052990321711 ()


  • Expiratory peak flow meter, digital
  • Pulse oximeter
Smart Spirometer and Oximeter connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Smart One Oxi
In Commercial Distribution

  • 08052990321704 ()


  • Expiratory peak flow meter, digital
  • Pulse oximeter
3mm 230cm Foreign Body Forcep
Surgical Direct, Inc.
SD60945
In Commercial Distribution

  • B382SD609450 ()

  • Length: 230 Centimeter
  • Outer Diameter: 3 Millimeter
SD60945

  • Endoscope sheath, reusable
Golf Club Foreign Body Spud
KRISHNA IMPORTS INC
S2-1135
In Commercial Distribution

  • 00810799031365 ()
S2-1135

  • Eye spud
Foreign Body Forceps, Pointed Tips
KRISHNA IMPORTS INC
S5-1890
In Commercial Distribution

  • 00810799035301 ()
S5-1890

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Foreign Body Retrieval Hood Protector
Avanos Medical, Inc.
92810
In Commercial Distribution

  • 10350770928101 ()
  • 00350770928104 ()
69392

  • Medical device cleaning sponge/set
MATHIEU FOREIGN BODY FORCEPS, 11"
HNM STAINLESS, LLC.
HNM-1-51-9028
In Commercial Distribution

  • 00842962125892 ()
HNM-1-51-9028

  • Dressing/utility forceps, tweezers-like, reusable
Foreign Body Magnet, Small Handle
SYNERGETICS USA, INC.
12.21S
In Commercial Distribution

  • 10841305103792 ()
12.21S

  • Ophthalmic soft-tissue manipulation forceps, probe-like, reusable
Moldenhauer foreign body lever 16cm
Medicon eG. Chirurgiemechaniker-Genossenschaft
62.14.40
In Commercial Distribution

  • 04046826102814 ()
62.14.40

  • ENT elevator
Schaaf foreign body fcps 9.5cm
Medicon eG. Chirurgiemechaniker-Genossenschaft
60.49.70
In Commercial Distribution

  • 04046826099985 ()
60.49.70

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Kuhnt foreign body gouge 12cm
Medicon eG. Chirurgiemechaniker-Genossenschaft
60.20.53
In Commercial Distribution

  • 04046826097769 ()
60.20.53

  • Eye spud/needle
foreign body needle cvd 12.5cm
Medicon eG. Chirurgiemechaniker-Genossenschaft
60.20.25
In Commercial Distribution

  • 04046826097721 ()
60.20.25

  • Eye spud/needle
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