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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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 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
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
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
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
H5 Scaler/904 Band Push Satin Steel Hdl
HU-FRIEDY MFG. CO., LLC
BP5625
In Commercial Distribution

  • 10889950042639 ()


  • Orthodontic metal band pusher
H5/Nevi #1 Sickle Scaler, EE2 Resin Purp
HU-FRIEDY MFG. CO., LLC
SNEV1/H5C8E2
In Commercial Distribution

  • 10889950030605 ()


  • Manual dental scaler, reusable
H5/Nevi #1 Curette, DE,EE2 #9 Handle
HU-FRIEDY MFG. CO., LLC
SNEV1/H59E2
In Commercial Distribution

  • 10889950030582 ()


  • Periodontal curette
#H5/NEVI #1 SICKLE Scaler DE, #7 HDL
HU-FRIEDY MFG. CO., LLC
SNEV1/H57
In Commercial Distribution

  • 10889950030551 ()


  • Manual dental scaler, reusable
H5/Nevi #1 Sickle, EE2 #9 Knurl Cone
HU-FRIEDY MFG. CO., LLC
SNEV1/H5G9E2
In Commercial Distribution

  • 10889950144623 ()


  • Manual dental scaler, reusable
#H5/33 DE Scaler, EE2 #9 Hdl, Purple
HU-FRIEDY MFG. CO., LLC
SH5/33V9E2
In Commercial Distribution

  • 10889950128241 ()
SH5/33V9E2

  • Dental mirror, reusable
H5/Nevi #1 Sickle, DE, EE2, Ergo Handle
HU-FRIEDY MFG. CO., LLC
SNEV1/H5XE2
In Commercial Distribution

  • 10889950127190 ()
SNEV1/H5XE2

  • Manual dental scaler, reusable
Dull H5/33 DE Scaler, Satin Steel Handle
HU-FRIEDY MFG. CO., LLC
678-910
In Commercial Distribution

  • 10889950004149 ()
678-910

  • Manual dental scaler, reusable
ACIF Depth Stop Trial, LG, Lordotic, H5/H6mm
CTL Medical Corporation
113.7455
In Commercial Distribution

  • 00841732139688 ()


  • General internal orthopaedic fixation system implantation kit
ACIF Depth Stop Trial, LG, Parallel, H5/H6mm
CTL Medical Corporation
113.7445
In Commercial Distribution

  • 00841732139640 ()


  • General internal orthopaedic fixation system implantation kit
SH5/U156 H5/U15 SCAL #6 HDL 1P
Peter Brasseler Holdings, LLC
5023411U0
In Commercial Distribution

  • 00887919682080 ()


  • Manual dental scaler, reusable
SH5/H5S6 H5/H5S SCAL #6 HDL 1P
Peter Brasseler Holdings, LLC
5023410U0
In Commercial Distribution

  • 00887919682073 ()


  • Manual dental scaler, reusable
SH5/486 H5/48 SCAL #6 HDL 1P
Peter Brasseler Holdings, LLC
5023408U0
In Commercial Distribution

  • 00887919682059 ()


  • Manual dental scaler, reusable
SV1/H56 SAVANNAH 1/H5 #6 HDL 1P
Peter Brasseler Holdings, LLC
5023453U0
In Commercial Distribution

  • 00887919682509 ()


  • Manual dental scaler, reusable
SH5/336 H5/33 SCAL #6 HDL 1P
Peter Brasseler Holdings, LLC
5023406U0
In Commercial Distribution

  • 00887919682035 ()


  • Manual dental scaler, reusable
AEON-C Stand Alone; TAV/TAV; 14x16; 7deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039837033 ()
CSAT2.14160705

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

  • 08800039836920 ()
CSAT2.14160005

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; TAV/TAV; 12x14; 15deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039836814 ()
CSAT2.12141505

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 15x18; 15deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835497 ()
CSA.15181505

  • Spinal fixation plate, non-bioabsorbable
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