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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Healing cap D4.5 H5 Conical 11deg RP
UNIQA DENTAL LTD
UOHR-4505
In Commercial Distribution

  • 07290112852137 ()
UOHR-4505

  • Dental implant suprastructure, permanent, preformed
Healing cap D4 H5 Conical 11deg RP
UNIQA DENTAL LTD
UOHR-4005
In Commercial Distribution

  • 07290112852090 ()
UOHR-4005

  • Dental implant suprastructure, permanent, preformed
Healing cap D4.5 H5 Conical 11deg MP
UNIQA DENTAL LTD
UOHM-4505
In Commercial Distribution

  • 07290112852069 ()
UOHM-4505

  • Dental implant suprastructure, permanent, preformed
Healing cap D4 H5 Conical 11deg MP
UNIQA DENTAL LTD
UOHM-4005
In Commercial Distribution

  • 07290112852045 ()
UOHM-4005

  • Dental implant suprastructure, permanent, preformed
Healing cap D5.5 H5 Internal Hex RP
UNIQA DENTAL LTD
UHCW-5505
In Commercial Distribution

  • 07290112851994 ()
UHCW-5505

  • Dental implant suprastructure, permanent, preformed
Healing cap D4.5 H5 Internal Hex RP
UNIQA DENTAL LTD
UHCR-4605
In Commercial Distribution

  • 07290112851932 ()
UHCR-4605

  • Dental implant suprastructure, permanent, preformed
Healing cap D4 H5 Internal Hex RP
UNIQA DENTAL LTD
UHCN-3505
In Commercial Distribution

  • 07290112851888 ()
UHCN-3505

  • Dental implant suprastructure, permanent, preformed
ACIF DISTRACTOR L14 x W16 x H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809489295400 ()
AC.0517

  • Bone-screw internal spinal fixation system, non-sterile
ACIF DISTRACTOR L12 x W14 x H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809489295325 ()
AC.0509

  • Bone-screw internal spinal fixation system, non-sterile
All-Poly Tibial Implant, PS, Size H5, 20mm
MAXX ORTHOPEDICS, INC.
ATPSLH520-AK
In Commercial Distribution

  • 00840333919392 ()


  • Uncoated knee tibia prosthesis, polyethylene
All-Poly Tibial Implant, PS, Size H5, 17mm
MAXX ORTHOPEDICS, INC.
ATPSLH517-AK
In Commercial Distribution

  • 00840333919385 ()


  • Uncoated knee tibia prosthesis, polyethylene
All-Poly Tibial Implant, PS, Size H5, 14mm
MAXX ORTHOPEDICS, INC.
ATPSLH514-AK
In Commercial Distribution

  • 00840333919378 ()


  • Uncoated knee tibia prosthesis, polyethylene
All-Poly Tibial Implant, PS, Size H5, 12mm
MAXX ORTHOPEDICS, INC.
ATPSLH512-AK
In Commercial Distribution

  • 00840333919361 ()


  • Uncoated knee tibia prosthesis, polyethylene
All-Poly Tibial Implant, PS, Size H5, 11mm
MAXX ORTHOPEDICS, INC.
ATPSLH511-AK
In Commercial Distribution

  • 00840333919354 ()


  • Uncoated knee tibia prosthesis, polyethylene
All-Poly Tibial Implant, PS, Size H5, 10mm
MAXX ORTHOPEDICS, INC.
ATPSLH510-AK
In Commercial Distribution

  • 00840333919347 ()


  • Uncoated knee tibia prosthesis, polyethylene
All-Poly Tibial Implant, PS, Size H5, 9mm
MAXX ORTHOPEDICS, INC.
ATPSLH509-AK
In Commercial Distribution

  • 00840333919330 ()


  • Uncoated knee tibia prosthesis, polyethylene
All-Poly Tibial Implant, UC, Size H5, 20mm
MAXX ORTHOPEDICS, INC.
ATUCLH520-AK
In Commercial Distribution

  • 00840333921630 ()


  • Uncoated knee tibia prosthesis, polyethylene
All-Poly Tibial Implant, UC, Size H5, 17mm
MAXX ORTHOPEDICS, INC.
ATUCLH517-AK
In Commercial Distribution

  • 00840333921623 ()


  • Uncoated knee tibia prosthesis, polyethylene
All-Poly Tibial Implant, UC, Size H5, 14mm
MAXX ORTHOPEDICS, INC.
ATUCLH514-AK
In Commercial Distribution

  • 00840333921616 ()


  • Uncoated knee tibia prosthesis, polyethylene
All-Poly Tibial Implant, UC, Size H5, 12mm
MAXX ORTHOPEDICS, INC.
ATUCLH512-AK
In Commercial Distribution

  • 00840333921609 ()


  • Uncoated knee tibia prosthesis, polyethylene
All-Poly Tibial Implant, UC, Size H5, 11mm
MAXX ORTHOPEDICS, INC.
ATUCLH511-AK
In Commercial Distribution

  • 00840333921593 ()


  • Uncoated knee tibia prosthesis, polyethylene
All-Poly Tibial Implant, UC, Size H5, 10mm
MAXX ORTHOPEDICS, INC.
ATUCLH510-AK
In Commercial Distribution

  • 00840333921586 ()


  • Uncoated knee tibia prosthesis, polyethylene
All-Poly Tibial Implant, UC, Size H5, 9mm
MAXX ORTHOPEDICS, INC.
ATUCLH509-AK
In Commercial Distribution

  • 00840333921579 ()


  • Uncoated knee tibia prosthesis, polyethylene
Periodontal Instrument, Scaler, Double Ended, HY-LITE Handle
A. TITAN INSTRUMENTS, INC.
H5 UL
In Commercial Distribution

  • 00841685107390 ()


  • Manual dental scaler, reusable
Perio Instrument, D-Lite Handle, Black
A. TITAN INSTRUMENTS, INC.
H5 DL
In Commercial Distribution

  • 00841685107383 ()


  • Manual dental scaler, reusable
Stand alone software used to collect, store and print patient data on various iOS devices
Zoll Medical Corporation
ZEPCRU
In Commercial Distribution

  • 00847946021924 ()


  • Medical equipment clinical data interfacing software
Kosmos Application loaded on an iPad.
ECHONOUS, INC.
iOS 4.X
Not in Commercial Distribution

  • 09353278000823 ()


  • Ultrasound imaging system application software
KOSMOS OTS iOS SOFTWARE PACKAGE [2.X]
ECHONOUS, INC.
P007944
In Commercial Distribution

  • 09353278000762 ()


  • Ultrasound imaging system application software
reSET-O® Mobile Application running on iOS. reSET-O is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Introductory Access Limited Version provides limited access to the reSET-O product.
PEAR THERAPEUTICS, INC.
1
Not in Commercial Distribution

  • 10851580008170 ()


  • Mental health/function therapeutic software, screen-viewed
reSET® Mobile Application running on iOS. reSET is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Introductory Access Limited Version provides limited access to the reSET product.
PEAR THERAPEUTICS, INC.
1
Not in Commercial Distribution

  • 10851580008149 ()


  • Mental health/function therapeutic software, screen-viewed
STRPR 1.2 APP, DEMO BL STREAMER PRO 1.2 APP CL
Oticon A/S
139340
In Commercial Distribution

  • 05707131268600 ()


  • Hearing aid neck induction loop, wireless input
STRPR 1.2 APP, LINKED WH STREAMER PRO 1.2 APP CL
Oticon A/S
139350
In Commercial Distribution

  • 05707131268587 ()


  • Hearing aid neck induction loop, wireless input
STRPR 1.2 APP, LINKED BL STREAMER PRO 1.2 APP CL
Oticon A/S
138119
In Commercial Distribution

  • 05707131268518 ()


  • Hearing aid neck induction loop, wireless input
Mobile application compatible to iOS operating system
ST. JUDE MEDICAL, INC.
APP1005
In Commercial Distribution

  • 05415067032829 ()
APP1005

  • Implantable cardiac device management application software
SW 31302 CARELINK EXPRESS MOBILE IOS USA
MEDTRONIC, INC.
31302
In Commercial Distribution

  • 00643169636668 ()


  • Implantable cardiac device management application software
SFTWR MMT-6104 MM MBL CLIN IOS 2.0.2
MEDTRONIC MINIMED, INC.
MMT-6104
Not in Commercial Distribution

  • 00763000521301 ()


  • Self-care monitoring/reporting software
Tandem t:slim Mobile Application, iOS version 2.9
Tandem Diabetes Care, Inc.
1014707
In Commercial Distribution

  • 00389152470740 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
DreamMapper iOS, North American Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054264 ()
1101478

  • Self-care monitoring/reporting software
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
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