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 Class Implantable

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On1 IOS Healing Cap 6 mm NP
Nobel Biocare AB
38734
In Commercial Distribution

  • 07332747113693 ()

  • Height: 6.000 Millimeter
38734

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 4 mm WP
Nobel Biocare AB
38739
In Commercial Distribution

  • 07332747191875 ()

  • Height: 4.000 Millimeter
38739

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 5 mm WP
Nobel Biocare AB
38738
In Commercial Distribution

  • 07332747191868 ()

  • Height: 5.000 Millimeter
38738

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 4.5 mm RP
Nobel Biocare AB
38737
In Commercial Distribution

  • 07332747191851 ()

  • Height: 4.500 Millimeter
38737

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 6 mm RP
Nobel Biocare AB
38736
In Commercial Distribution

  • 07332747191844 ()

  • Height: 6.000 Millimeter
38736

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 4.5 mm NP
Nobel Biocare AB
38735
In Commercial Distribution

  • 07332747191837 ()

  • Height: 4.500 Millimeter
38735

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 6 mm NP
Nobel Biocare AB
38734
In Commercial Distribution

  • 07332747191820 ()

  • Height: 6.000 Millimeter
38734

  • Dental implant suprastructure, temporary, preformed, single-use
NP IOS Model Implant Replica CC WP
Nobel Biocare AB
38191
Not in Commercial Distribution

  • 07332747175967 ()
38191

  • Dental implant suprastructure, temporary, preformed, single-use
NP IOS Model Implant Replica CC RP
Nobel Biocare AB
38190
Not in Commercial Distribution

  • 07332747175950 ()
38190

  • Dental implant suprastructure, temporary, preformed, single-use
NP IOS Model Implant Replica CC NP
Nobel Biocare AB
38189
Not in Commercial Distribution

  • 07332747175943 ()
38189

  • Dental implant suprastructure, temporary, preformed, single-use
SFTWR MMT-8100 IOS WATSON APP V2.1 UDI
MEDTRONIC MINIMED, INC.
MMT-8100
In Commercial Distribution

  • 00763000086619 ()


  • Self-care monitoring/reporting software
SFTWR CSS7200 GRDN MBL APP IOS V3.2.3
MEDTRONIC MINIMED, INC.
CSS7200
In Commercial Distribution

  • 00763000186333 ()


  • Patient health record information system application software
SFTWR MMT-8100 IOS WATSON APP V3.0 UDI
MEDTRONIC MINIMED, INC.
MMT-8100
In Commercial Distribution

  • 00763000168643 ()


  • Self-care monitoring/reporting software
NP IOS Model Implant Replica CC 3.0
Nobel Biocare AB
38188
Not in Commercial Distribution

  • 07332747175936 ()

  • Outer Diameter: 3.000 Millimeter
38188

  • Dental implant suprastructure, temporary, preformed, single-use
Lumify Diagnostic Ultrasound System iOS Release 5.1
Philips Ultrasound LLC
795161
In Commercial Distribution

  • 00884838124141 ()


  • General-purpose ultrasound imaging system
SFTWR MMT-6104 MM MBL CLIN IOS 1.0.0
MEDTRONIC MINIMED, INC.
MMT-6104
Not in Commercial Distribution

  • 00763000480677 ()


  • Self-care monitoring/reporting software
SW MMT-8060 INPEN 2.0 IOS APP US
MEDTRONIC MINIMED, INC.
MMT-8060
In Commercial Distribution

  • 00763000974589 ()


  • Empty self-injector, mechanical
G5 Mobile IOS App Stand Alone Software
Dexcom, Inc.
SW10611
In Commercial Distribution

  • 00386270000002 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
SFTWR MMT-8400 1.1 CGM MODULE IOS US
MEDTRONIC MINIMED, INC.
MMT-8400
In Commercial Distribution

  • 00763000721350 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
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
Sleep Apnea Notification Feature iOS (version 1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949116209 ()


  • Self-care monitoring/reporting software
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 Model Implant Replica CC WP
Nobel Biocare AB
38191
In Commercial Distribution

  • 07332747212570 ()
38191

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

  • 07332747212563 ()
38190

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

  • 07332747212556 ()
38189

  • Dental implant suprastructure, temporary, preformed, single-use
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 3.0
Nobel Biocare AB
38188
In Commercial Distribution

  • 07332747212549 ()

  • Outer Diameter: 3.000 Millimeter
38188

  • Dental implant suprastructure, temporary, preformed, single-use
Transducer C9-4ec as part of Lumify 5.1 iOS
Philips Ultrasound LLC
300013145921
In Commercial Distribution

  • 00884838123762 ()


  • Rectal/vaginal ultrasound imaging transducer
Also covers the following minor/medium updates: v3.1.0 (01)00860001471724(11)210526(10)310; v3.1.1 (01)00860001471724(11)210604(10)311; v3.1.2 (01)00860001471724(11)210625(10)312; v3.2.0 (01)00860001471724(11)210713(10)320; v3.2.1. (01)00860001471724(11)210804(10)321; v3.2.2 (01)00860001471724(11)210917(10)322; v3.2.3 (01)00860001471724(11)211026(10)323 ;v3.2.4 (01)00860001471724(11)211123(10)324; v3.7.0 (01)00860001471724(11) 221116(10)370; v3.6.2 (01)00860001471724(11) 221024(10)362; v3.4.0:(01)00860001471724(11)220609(10)350; v3.5.1(01)00860001471724(11)220718(10)351; v3.6.0 (01)00860001471724(11) 220926(10)360; v3.8.0 (01)00860001471724(11) 221215(10)380; v3.8.1 (01)00860001471724(11) 230127(10)381; v3.9.0 (01)00860001471724(11) 230217(10)390; v3.9.1 (01)00860001471724(11) 230417(10)391; v3.9.2 (01)00860001471724(11) 230609(10)392; v3.9.3 (01)00860001471724(11) 230714(10)393; v3.10.0 (01)00860001471724(11) 231013(10)3100
AMPLIFON SPA
iOS v3
In Commercial Distribution

  • 00860001471724 ()


  • Hearing aid/implant system remote control
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
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
No Description
Clarius Mobile Health Corp
App - iOS
In Commercial Distribution

  • 07540205000397 ()
12-01-00003

  • Ultrasound imaging system application software
  • Radiological PACS software
APP, Bluetooth, otoTune iOS for self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990019-SWH
In Commercial Distribution

  • 00850016231383 ()


  • Audiometric/hearing device software
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