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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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Lilly Together - 00300021175559

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
MA9140 IOS (Version 12)
In Commercial Distribution

  • 00300021175559 ()
MA9140001AM

  • Medication reminder application software
  • Patient subjective symptom recorder

Lilly Together - 00300021107550

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

DIGITIVA Mobile Application - 00304692416089

Software as a Medical Device (SaMD) which operates as a medication reminder and support services; Operates on Apple iOS devices.
Astellas Pharma Us, Inc.
iOS (Version 1)
In Commercial Distribution

  • 00304692416089 ()
DIGI-001

  • Medication reminder application software

JO H2O Flavored Green Apple 4oz/120ml - B362403850

Water-based Personal Lubricant
CC Wellness LLC
40385
In Commercial Distribution

  • B362403851 ()
  • B362403850 ()


  • Sexual lubricant

JO H2O Flavored Green Apple 1oz/30ml - B362103850

Water-based Personal Lubricant
CC Wellness LLC
10385
In Commercial Distribution

  • B362103851 ()
  • B362103850 ()


  • Sexual lubricant

BP100 & Baha 4 Battery door Apple Green - 09321502021012

No Description
Cochlear Bone Anchored Solutions AB
92575
In Commercial Distribution

  • 09321502021012 ()
  • 09321502039109 ()
92575

  • Bone-conduction hearing implant system sound processor/vibrator

bebird - 00850030574060

Ear Wax Removal System. View and safely clean your ear canal. The bebird cleaning rod wireless connects to your apple or android phone or tablet allowing the user to see high resolution images of their outer ear canal.
Be Bird Usa, Inc
W3-WM-BK
In Commercial Distribution

  • 00850030574060 ()
HVRS

  • Otoscope, endoscopic

Console iOptima - J00716009260011

iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1600926-001
In Commercial Distribution

  • J00716009260011 ()
1600926-001

  • Surgical power tool system control unit, line-powered

Console Optima MX2 INT - J00716007150011

iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1600715-001
In Commercial Distribution

  • J00716007150011 ()
1600715-001

  • Surgical power tool system control unit, line-powered

CONSOLE OPTIMA MX INT - J00716005340011

iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1600534-001
In Commercial Distribution

  • J00716005340011 ()
1600534-001

  • Surgical power tool system control unit, line-powered

iOptima APP - J00714000630631

iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400063
In Commercial Distribution

  • J00714000630631 ()
1400063

  • Dental treatment application software

Console iOptima INT MX2 MX-i - J00716010760011

iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1601076-001
In Commercial Distribution

  • J00716010760011 ()
1601076-001

  • Surgical power tool system control unit, line-powered

Console iOptima INT 2x MX2 - J00716010750011

iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1601075-001
In Commercial Distribution

  • J00716010750011 ()
1601075-001

  • Surgical power tool system control unit, line-powered

Console iOptima INT 1x MX2 - J00716010740011

iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1601074-001
In Commercial Distribution

  • J00716010740011 ()
1601074-001

  • Surgical power tool system control unit, line-powered

KONMED /Pelvifine - 06970935830543

This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.
Shenzhen Konmed Technology Co., Ltd.
KM531
In Commercial Distribution

  • 06970935830543 ()


  • Pelvic floor exercise biofeedback device

KONMED /Pelvifine - 06970935830536

This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.
Shenzhen Konmed Technology Co., Ltd.
KM530
In Commercial Distribution

  • 06970935830536 ()


  • Pelvic floor exercise biofeedback device

Orthodontic Plier - 00810152825662

How chop plier
Ortho Pro Dent LLC
OP-112
In Commercial Distribution

  • 00810152825662 ()


  • Orthodontic pliers

Orthodontic Plier - 00810152825655

How Plier angled
Ortho Pro Dent LLC
OP-111
In Commercial Distribution

  • 00810152825655 ()


  • Orthodontic pliers

Henry Schein - 00304040120392

Maxima How Pliers
HENRY SCHEIN, INC.
9007609
In Commercial Distribution

  • 00304040120392 ()
9007609

  • Orthodontic pliers

Orthopli - D017O11A0

How Plier (ANGULATED)
ORTHOPLI CORP.
O11-A
In Commercial Distribution

  • D017O11A0 ()


  • Orthodontic pliers

American Eagle Instruments - 00841013101755

HOW PLIERS STRAIGHT
AMERICAN EAGLE INSTRUMENTS, INC.
AE201-106
Not in Commercial Distribution

  • 00841013101755 ()
AE201-106

  • Orthodontic pliers

ORTHOSOURCE - D9118711030

Superb How Curved
ORTHOSOURCE
871-103
In Commercial Distribution

  • D9118711030 ()


  • Orthodontic pliers

ORTHOSOURCE - D9118711020

Superb How Large
ORTHOSOURCE
871-102
In Commercial Distribution

  • D9118711020 ()


  • Orthodontic pliers

ORTHOSOURCE - D9118711010

Superb How Small
ORTHOSOURCE
871-101
In Commercial Distribution

  • D9118711010 ()


  • Orthodontic pliers

Orthopli - D917O110

How Plier (straight)
ORTHOPLI CORP.
O11
In Commercial Distribution

  • D917O110 ()


  • Orthodontic pliers

HU-FRIEDY - 10889950003340

How Pliers, Offset
HU-FRIEDY MFG. CO., LLC
678-204
In Commercial Distribution

  • 10889950003340 ()
678-204

  • Orthodontic pliers

HU-FRIEDY - 10889950003333

How Pliers, Straight
HU-FRIEDY MFG. CO., LLC
678-203
In Commercial Distribution

  • 10889950003333 ()
678-203

  • Orthodontic pliers

SCHWERT - E8965324F0

HOW pliers cvd.carb.coat
A. Schweickhardt GmbH & Co. KG
5324-F
In Commercial Distribution

  • E8965324F0 ()
5324-F

  • Wire holding/twisting pliers

Darby Dental Supply, LLC - 00889813066607

PLIER HOW STRAIGHT
DARBY DENTAL SUPPLY, LLC
5257309
In Commercial Distribution

  • 00889813066607 ()


  • Surgical flat-nosed pliers

Darby Dental Supply, LLC - 00889813066591

PLIER HOW CURVED
DARBY DENTAL SUPPLY, LLC
5257308
In Commercial Distribution

  • 00889813066591 ()


  • Orthopaedic cerclage applier

Quinelato - 07898506813957

Curved How pliers
Schobell Industrial Ltda
QO.111.00
In Commercial Distribution

  • 07898506813957 ()
QO.111.00

  • Orthodontic pliers

Quinelato - 07898506813940

Straight How pliers
Schobell Industrial Ltda
QO.110.00
In Commercial Distribution

  • 07898506813940 ()
QO.110.00

  • Orthodontic pliers

Pomee - G15771530

How Plier, Curved
POMEE CORPORATION
7153
In Commercial Distribution

  • G15771530 ()
7153

  • Orthodontic pliers

Ormco Premium - 00889989082364

OFFSET HOW PLIERS
ORMCO CORPORATION
866-2017
In Commercial Distribution

  • 00889989082364 ()


  • Orthodontic pliers

Ormco Premium - 00889989082357

STRAIGHT HOW PLIERS
ORMCO CORPORATION
866-2016
In Commercial Distribution

  • 00889989082357 ()


  • Orthodontic pliers

LEONE SPA - 08033707069478

HOW PLIERS CURVED
LEONE SPA
P1909-00
In Commercial Distribution

  • 08033707069478 ()
P1909-00

  • Orthodontic pliers

LEONE SPA - 08033707069461

HOW PLIERS STRAIGHT
LEONE SPA
P1908-00
In Commercial Distribution

  • 08033707069461 ()
P1908-00

  • Orthodontic pliers

LEONE SPA - 08033707069454

HOW PLIERS STRAIGHT
LEONE SPA
P1907-00
In Commercial Distribution

  • 08033707069454 ()
P1907-00

  • Orthodontic pliers

Schweickhardt - 00885797097163

HOW PLIER CURVED
Rmo, Inc.
I00111
In Commercial Distribution

  • 00885797097163 ()


  • Orthodontic pliers

Schweickhardt - 00885797097156

HOW PLIER STRAIGHT
Rmo, Inc.
I00110
In Commercial Distribution

  • 00885797097156 ()


  • Orthodontic pliers

NightWare - 00860005400706

The NightWare device includes a software application and the NightWare server. The device uses an Apple Watch® and an Apple iPhone® for its platform. These components monitor your sleep behavior and, using a proprietary formula, creates a unique sleep profile to help you get a better night’s sleep. NightWare is designed to monitor your heart rate and movement throughout the night and occasionally provide vibrotactile interventions (haptic feedback) through the Apple Watch while you are sleeping. These interventions will occur when NightWare detects that you have exceeded a certain threshold and will disrupt the phenomena consistent with a nightmare at the time that it is occurring. The first night you use NightWare, the watch will not provide any of these interventions because it is gathering enough data to create your unique sleep profile. The data that NightWare collects from the Apple Watch includes: Heart Rate, Body Movement (Acceleration),Body Position (Rotation). This information is securely sent to the NightWare servers and processed to help you improve the quality of your sleep.
Nightware Incorporated
100001
In Commercial Distribution

  • 00860005400706 ()


  • Sleep disorder interpretive software, patient-use

Miracle Ear App - 00860001471731

Also covers the following minor/medium updates: v3.1.0: (01)00860001471731(11)210526(10)310; v3.1.1 (01)00860001471731(11)210604(10)311; v3.1.2 (01)00860001471731(11)210625(10)312; v3.2.0 (01)00860001471731(11)210713(10)320; v3.2.1. (01)00860001471731(11)210804(10)321; v3.2.2 (01)00860001471731(11)210917(10)322; v3.2.3 (01)00860001471731(11)211026(10)323 ;v3.2.4 (01)00860001471731(11)211123(10)324; v3.4.0: (01)00860001471731(11)220609(10)340; v3.5.1 (01)00860001471731(11)220718(10)351; v3.6.0 (01)00860001471731(11)220926(10)360; v3.6.2(01)00860001471731(11)221024(10)362; v3.7.0(01)00860001471731(11)221116(10)370; v3.8.0(01)00860001471731(11)221215(10)380; v3.8.1(01)00860001471731(11)230127(10)381; v3.9.0(01)00860001471731(11)230217(10)390; v3.9.1(01)00860001471731(11)230417(10)391; v3.9.2 (01)00860001471731(11)230609(10)392; v3.9.3 (01)00860001471731(11)230714(10)393; v3.10.0 (01)00860001471731(11)231013(10)3100
AMPLIFON SPA
Android v3
In Commercial Distribution

  • 00860001471731 ()


  • Hearing aid/implant system remote control

Miracle Ear App - 00860001471724

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

Miracle-Ear App - 00860001471717

App Android 2.0.1. This database entry also covers the following minor/medium software updates: v2.0.2: (01)00860001471717(11)190807(10)202; v2.0.3: (01)00860001471717(11)190927(10)203; v2.0.4: (01)00860001471717(11)191014(10)204; v2.0.5: (01)00860001471717(11)191218(10)205; v2.0.6: (01)00860001471717(11)200227(10)206; v2.1.0: (01)00860001471717(11)200420(10)210; v2.2.1: (01)00860001471717(11)200729(10)221; v2.3.0: (01)00860001471717(11)201217(10)230; v2.3.1: (01)00860001471717(11)210205(10)231; v2.3.2: (01)00860001471717(11)210507(10)232
AMPLIFON SPA
2.0.1
In Commercial Distribution

  • 00860001471717 ()


  • Hearing aid/implant system remote control

Miracle-Ear App - 00860001471700

App IOS 2.0.1. This database entry also covers the following minor/medium software updates: v2.0.2: (01)00860001471700(11)190807(10)202; v2.0.3: (01)00860001471700(11)190927(10)203; v2.0.4: (01)00860001471700(11)191014(10)204; v2.0.5: (01)00860001471700(11)191218(10)205; v2.0.6:(01)00860001471700(11)200227(10)206; v2.1.0: (01)00860001471700(11)200528(10)210; v2.2.1: (01)00860001471700(11)200729(10)221; v2.3.0: (01)00860001471700(11)201217(10)230; v2.3.1: (01)00860001471700(11)210205(10)231; v2.3.2: (01)00860001471700(11)210507(10)232
AMPLIFON SPA
2.0.1
In Commercial Distribution

  • 00860001471700 ()


  • Hearing aid/implant system remote control

Surgical Direct - B382SD902972030

How Utility Pliers, Straight
Surgical Direct, Inc.
SD90297203
In Commercial Distribution

  • B382SD902972030 ()
SD90297203

  • Dressing/utility forceps, scissors-like, reusable

Henry Schein - 00304040049327

Plier How 111 Curved
HENRY SCHEIN, INC.
1127204
In Commercial Distribution

  • 00304040049327 ()
1127204

  • Orthodontic pliers

Henry Schein - 00304040049310

Plier How 110 Straight
HENRY SCHEIN, INC.
1127203
In Commercial Distribution

  • 00304040049310 ()
1127203

  • Orthodontic pliers

ELMED - 00842180184114

How Crown Pliers Straight
ELMED INCORPORATED
01-7420
In Commercial Distribution

  • 00842180184114 ()
01-7420

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable

X7 - 00190730083753

Standard How Utility Plier
ORTHO TECHNOLOGY, INC.
400-115
Not in Commercial Distribution

  • 00190730083753 ()


  • Orthodontic pliers
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