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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TC Discover App UDID
PRENTKE ROMICH COMPANY
Discover App
In Commercial Distribution

  • 00816486021367 ()
19285-9

  • Voice synthesizer/digitizer
Hearing Remote 5.0 app
Sonova AG
088-5017
In Commercial Distribution

  • 07613389610925 ()
088-5017

  • Audiometric/hearing device software
All-Day Clear 1.0 app
Sonova AG
088-5015
In Commercial Distribution

  • 07613389557930 ()
088-5015

  • Audiometric/hearing device software
Easy Line remote App
Sonova AG
088-0010
In Commercial Distribution

  • 07613389310962 ()
088-0010

  • Audiometric/hearing device software
HANSATON Stream Remote App
Hansaton Akustik GmbH
088-5003
In Commercial Distribution

  • 07613389127225 ()
088-5003

  • Audiometric/hearing device software
Unitron Remote Plus app
Unitron Hearing Division
088-5001
In Commercial Distribution

  • 07613389075823 ()
088-5001

  • Audiometric/hearing device software
BARIATRIC APP PAD ONLY
COMPASS HEALTH BRANDS CORP.
1105
In Commercial Distribution

  • 30815067042563 ()
  • 00815067042562 ()


  • Alternating-pressure bed mattress overlay, reusable
APP SYSTEM AIR ADJUSTABLE
COMPASS HEALTH BRANDS CORP.
1003
In Commercial Distribution

  • 30815067040163 ()
  • 00815067040162 ()


  • Alternating-pressure bed mattress overlay system
CIONIC Android Gateway App
Cionic, Inc.
10
In Commercial Distribution

  • G345620000040 ()
62000004

  • Gait-enhancement electrical stimulation system, external
Biim Android App, P2.0
Biim Ultrasound AS
P001425
In Commercial Distribution

  • 07090045490334 ()
P001425

  • Hand-held ultrasound imaging system, body-surface
  • Extracorporeal ultrasound imaging transducer, hand-held
Biim Android App, P1.3.2
Biim Ultrasound AS
P001418
In Commercial Distribution

  • 07090045490310 ()
P001418

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim Android App, P1.3.1
Biim Ultrasound AS
P001403
In Commercial Distribution

  • 07090045490235 ()
P001403

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim Android App, P1.3
Biim Ultrasound AS
P001228
In Commercial Distribution

  • 07090045490198 ()
P001228

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim Android App, P1.2
Biim Ultrasound AS
P001158
In Commercial Distribution

  • 07090045490150 ()
P001158

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim Android App, P1.1
Biim Ultrasound AS
P001118
In Commercial Distribution

  • 07090045490020 ()
P001118

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Aadva™ IOS 100: IOS cart, IOS Handpiece (via USB connection), CPU (onboard computer), G.U.I. touchscreen, holder inserts bags of 10, plug, IFUs (includes: Quick Start Guide & Owners manual).
Gc America Inc.
940502
In Commercial Distribution

  • J0229405021 ()
940502

  • Dental milling system, CAD/CAM, laboratory
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices.
ELI LILLY AND COMPANY
MA7723 IOS
In Commercial Distribution

  • 00300021107550 ()
MA7723001AM

  • Medication reminder application software
The device is an optical impression system. It is used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer-aided design (CAD) and computer-aided manufacturing (CAM) of dental restorative prosthetic devices.
CEFLA SOCIETA' COOPERATIVA
NewTom IOS
In Commercial Distribution

  • 08033837932970 ()
70960000

  • Intraoral optical scanning system
  • Dental milling system, CAD/CAM, chairside
Sleep Apnea Notification Feature iOS (version 1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949116209 ()


  • Self-care monitoring/reporting software
Transducer C9-4ec as part of Lumify 5.1 iOS
Philips Ultrasound LLC
300013145921
In Commercial Distribution

  • 00884838123762 ()


  • Rectal/vaginal ultrasound imaging transducer
AirStrip Cardiology, Patient Monitoring and OB - Client iOS
Airstrip Technologies, Inc.
2001
In Commercial Distribution

  • B15320010 ()


  • Bedside monitor remote-viewing software, physiological parameter
NobelProcera® IOS Replica Insertion Tool CC WP
Nobel Biocare AB
38204
In Commercial Distribution

  • 07332747096422 ()
38204

  • Dental implant suprastructure, temporary, preformed, reusable
NobelProcera® IOS Replica Insertion Tool CC RP
Nobel Biocare AB
38203
In Commercial Distribution

  • 07332747096415 ()
38203

  • Dental implant suprastructure, temporary, preformed, reusable
NobelProcera® IOS Replica Insertion Tool CC NP
Nobel Biocare AB
38201
In Commercial Distribution

  • 07332747096408 ()
38201

  • Dental implant suprastructure, temporary, preformed, reusable
NobelProcera® IOS Replica Insertion Tool CC 3.0
Nobel Biocare AB
38200
In Commercial Distribution

  • 07332747096392 ()

  • Outer Diameter: 3.000 Millimeter
38200

  • Dental implant suprastructure, temporary, preformed, reusable
NobelProcera® IOS Model Implant Replica CC WP
Nobel Biocare AB
38191
In Commercial Distribution

  • 07332747096316 ()
38191

  • Dental implant suprastructure, temporary, preformed, single-use
NobelProcera® IOS Model Implant Replica CC RP
Nobel Biocare AB
38190
In Commercial Distribution

  • 07332747096309 ()
38190

  • Dental implant suprastructure, temporary, preformed, single-use
NP IOS Model Implant Replica Conical Connection NP
Nobel Biocare AB
38189
In Commercial Distribution

  • 07332747096293 ()
38189

  • Dental implant suprastructure, temporary, preformed, single-use
NobelProcera® IOS Model Implant Replica CC 3.0
Nobel Biocare AB
38188
In Commercial Distribution

  • 07332747096286 ()

  • Outer Diameter: 3.000 Millimeter
38188

  • Dental implant suprastructure, temporary, preformed, single-use
NobelProcera® IOS Model Implant Replica CC WP
Nobel Biocare AB
38191
In Commercial Distribution

  • 07332747212570 ()
38191

  • Dental implant suprastructure, temporary, preformed, single-use
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