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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AEON-C Stand Alone; TAV; 15x18; 0deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039836265 ()
CSAT.15180005

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; TAV; 14x16; 7deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039836043 ()
CSAT.14160705

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; TAV; 14x16; 0deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835930 ()
CSAT.14160005

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; TAV; 12x14; 7deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835718 ()
CSAT.12140705

  • Spinal fixation plate, non-bioabsorbable
MOBI-C IMPLANT M « STANDARD » 17x19 H5 US
LDR Spine Usa, Inc.
MB3795
In Commercial Distribution

  • 03662663002042 ()

  • Height: 5 Millimeter
  • Depth: 17 Millimeter
  • Width: 19 Millimeter
MB3795

  • Cervical total intervertebral disc prosthesis, modular
MOBI-C IMPLANT M « STANDARD » 17x17 H5 US
LDR Spine Usa, Inc.
MB3775
In Commercial Distribution

  • 03662663002011 ()

  • Width: 17 Millimeter
  • Depth: 17 Millimeter
  • Height: 5 Millimeter
MB3775

  • Cervical total intervertebral disc prosthesis, modular
MOBI-C IMPLANT M « STANDARD » 19x19 H5 US
LDR Spine Usa, Inc.
MB3995
In Commercial Distribution

  • 03662663002073 ()

  • Width: 19 Millimeter
  • Depth: 19 Millimeter
  • Height: 5 Millimeter
MB3995

  • Cervical total intervertebral disc prosthesis, modular
ROI-C Lordotic Rounded Tooth Trial 12x14 H5
LDR Spine Usa, Inc.
SI-ROIC-0116
In Commercial Distribution

  • 03662663047432 ()

  • Height: 5 Millimeter
  • Width: 14 Millimeter
  • Depth: 12 Millimeter
SI-ROIC-0116

  • Spinal implant trial
SCALER DE #H5/33 QUALA S HND
NORDENT MANUFACTURING INC
SH5-33/SQ
In Commercial Distribution

  • 00840018602311 ()


  • Manual dental scaler, reusable
SCALER DE #H5/33 QUALA 6 HND
NORDENT MANUFACTURING INC
SH5-33/6Q
In Commercial Distribution

  • 00840018602304 ()


  • Manual dental scaler, reusable
SCALER DE #H5/33 QUALA 4 HND
NORDENT MANUFACTURING INC
SH5-33/4Q
In Commercial Distribution

  • 00840018602298 ()


  • Manual dental scaler, reusable
BDS SCALER SICKLE.JACQUETTE #H5/33 #6 HD
NORDENT MANUFACTURING INC
SH5-33/6BH
In Commercial Distribution

  • 00840018604575 ()


  • Manual dental scaler, reusable
Nobel Active RP Multi-Unit Abutment H5 Uniblock
Open Implants, LLC
4933
In Commercial Distribution

  • D86349330 ()


  • Dental implant suprastructure, permanent, preformed
Nobel Active NP Multi-Unit Abutment H5 Uniblock
Open Implants, LLC
4932
In Commercial Distribution

  • D86349320 ()


  • Dental implant suprastructure, permanent, preformed
Healing cap D7 H5 Conical 11deg RP
UNIQA DENTAL LTD
UOHR-7005
In Commercial Distribution

  • 07290112852212 ()
UOHR-7005

  • Dental implant suprastructure, permanent, preformed
Healing cap D6 H5 Conical 11deg RP
UNIQA DENTAL LTD
UOHR-6005
In Commercial Distribution

  • 07290112852182 ()
UOHR-6005

  • Dental implant suprastructure, permanent, preformed
Healing cap D5 H5 Conical 11deg RP
UNIQA DENTAL LTD
UOHR-5005
In Commercial Distribution

  • 07290112852151 ()
UOHR-5005

  • Dental implant suprastructure, permanent, preformed
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 D6.3 H5 Internal Hex RP
UNIQA DENTAL LTD
UHCW-6305
In Commercial Distribution

  • 07290112859327 ()
UHCW-6305

  • Dental implant suprastructure, permanent, preformed
Straight abutment wide H5 Internal Hex RP
UNIQA DENTAL LTD
USBW-5505
In Commercial Distribution

  • 07290112857453 ()
USBW-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
JACQUETTE SCLR RND HD DE H5/33
SKLAR CORPORATION
49-2750
In Commercial Distribution

  • 10649111103247 ()


  • Manual dental scaler, reusable
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
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
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
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
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
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