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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No Description
CURBELL MEDICAL PRODUCTS, INC.
Rego Safe Mobility App
In Commercial Distribution

  • 00840828192095 ()


  • Inpatient motion surveillance software
Eversense CGM Mobile Application (Android) is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5502-02-300
In Commercial Distribution

  • 00817491023537 ()
FG-5502-02-300

  • Implantable glucose monitoring system
Mobile App utilized in the PDM (Personal Device Manager) for Dash. Insulin pump secondary display. PDM Device 18239; app 41253
Insulet Corporation
1.3.1
In Commercial Distribution

  • 10385081120272 ()
18239

  • Ambulatory insulin infusion pump software, data-display
Mobile App utilized in the PDM (Personal Device Manager) for Dash Insulin pump secondary display. PDM Device 18239; app 41252
Insulet Corporation
1.3.1
In Commercial Distribution

  • 10385081120265 ()
18239

  • Ambulatory insulin infusion pump software, data-display
Babysat System Application.
Owlet Baby Care, Inc.
2.23.0
In Commercial Distribution

  • 00810099090079 ()


  • Multiple vital physiological parameter monitoring system, home-use
for Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622925-100
In Commercial Distribution

  • 00802526607608 ()
622925-100

  • Implantable cardiac device management application software
For Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622929-120
Not in Commercial Distribution

  • 00802526623110 ()
2929

  • Implantable cardiac device management application software
for Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622939-120
Not in Commercial Distribution

  • 00802526623103 ()
2939

  • Implantable cardiac device management application software
for Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
2939
In Commercial Distribution

  • 00802526618215 ()
2939

  • Implantable cardiac device management application software
For Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
2929
In Commercial Distribution

  • 00802526618208 ()
2929

  • Implantable cardiac device management application software
The ZEUS ELISA Thyroglobulin (Tg) IgG Test System is intended for the qualitative and semi-quantitative detection of IgG-class antibody to thyroglobulin in human serum. The test system is intended to be used as an aid in the diagnosis of thyroid diseases. This test is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
2Z5061G
In Commercial Distribution

  • 00845533001175 ()
2Z5061G

  • Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA)
No Description
OSANG HEALTHCARE Co., Ltd.
ILM-0001A
In Commercial Distribution

  • 08809115905444 ()


  • Total cholesterol lipid IVD, kit, chemiluminescent immunoassay, rapid
No Description
Berman Instruments LLC
CKP13
Not in Commercial Distribution

  • 00810060722206 ()


  • Periodontal hoe
No Description
MONOBIND, INC.
TG-300
In Commercial Distribution

  • 00816870020198 ()

  • Width: 2 Inch
TG-300

  • Thyroglobulin antibody IVD, control
Scan Body with Screw Compatible with Astra Tech OsseoSpeed 3.5/4.0 IOS
Biodenta Swiss AG
CAD-SBATOS3545
In Commercial Distribution

  • 07640169736346 ()
CAD-SBATOS3545

  • Dental implant abutment analog, intraoral-scanning, single-use
4.8mm Diameter, 6.5mm Platform TG Implant Length 14mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/6TG14S2
In Commercial Distribution

  • 00842448114457 ()


  • Dental implant system
4.8mm Diameter, 6.5mm Platform TG Implant Length 14mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/6TG14R1
In Commercial Distribution

  • 00842448114365 ()


  • Dental implant system
4.8mm Diameter, 4.8mm Platform TG Implant Length 12mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/4TG12S2
In Commercial Distribution

  • 00842448114297 ()


  • Dental implant system
4.8mm Diameter, 6.5mm Platform TG Implant Length 12mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/6TG12S2
In Commercial Distribution

  • 00842448114433 ()


  • Dental implant system
4.8mm Diameter, 6.5mm Platform TG Implant Length 10mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/6TG10S2
In Commercial Distribution

  • 00842448114419 ()


  • Dental implant system
4.8mm Diameter, 4.8mm Platform TG Implant Length 14mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/4TG14S2
In Commercial Distribution

  • 00842448114310 ()


  • Dental implant system
4.8mm Diameter, 4.8mm Platform TG Implant Length 10mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/4TG10S2
In Commercial Distribution

  • 00842448114273 ()


  • Dental implant system
4.8mm Diameter, 4.8mm Platform TG Implant Length 8mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/4TG8S2
In Commercial Distribution

  • 00842448114259 ()


  • Dental implant system
4.8mm Diameter, 4.8mm Platform TG Implant Length 14.0mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/4TG14R1
In Commercial Distribution

  • 00842448114228 ()


  • Dental implant system
4.8mm Diameter, 4.8mm Platform TG Implant Length 10.0mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/4TG10S1
In Commercial Distribution

  • 00842448114198 ()


  • Dental implant system
4.8mm Diameter, 4.8mm Platform TG Implant Length 10.0mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/4TG10R1
In Commercial Distribution

  • 00842448114181 ()


  • Dental implant system
4.8mm Diameter, 4.8mm Platform TG Implant Length 8mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/4TG8R1
In Commercial Distribution

  • 00842448114167 ()


  • Dental implant system
4.1mm Diameter, 4.8mm Platform TG Implant Length 14mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-41/4TG14S2
In Commercial Distribution

  • 00842448114150 ()


  • Dental implant system
4.1mm Diameter, 4.8mm Platform TG Implant Length 12mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-41/4TG12S2
In Commercial Distribution

  • 00842448114136 ()


  • Dental implant system
4.1mm Diameter, 4.8mm Platform TG Implant Length 10mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-41/4TG10S2
In Commercial Distribution

  • 00842448114112 ()


  • Dental implant system
4.1mm Diameter, 4.8mm Platform TG Implant Length 14mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-41/4TG14R1
In Commercial Distribution

  • 00842448114068 ()


  • Dental implant system
4.1mm Diameter, 4.8mm Platform TG Implant Length 12mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-41/4TG12S1
In Commercial Distribution

  • 00842448114051 ()


  • Dental implant system
4.1mm Diameter, 4.8mm Platform TG Implant Length 12mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-41/4TG12R1
In Commercial Distribution

  • 00842448114044 ()


  • Dental implant system
4.1mm Diameter, 4.8mm Platform TG Implant Length 10mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-41/4TG10S1
In Commercial Distribution

  • 00842448114037 ()


  • Dental implant system
4.1mm Diameter, 4.8mm Platform TG Implant Length 8mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-41/4TG8R1
In Commercial Distribution

  • 00842448114006 ()


  • Dental implant system
3.3mm Diameter, 4.8mm Platform TG Implant Length 14mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG14S1
In Commercial Distribution

  • 00842448113993 ()


  • Dental implant system
3.3mm Diameter, 4.8mm Platform TG Implant Length 14mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG14R1
In Commercial Distribution

  • 00842448113986 ()


  • Dental implant system
3.3mm Diameter, 4.8mm Platform TG Implant Length 12mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG12S1
In Commercial Distribution

  • 00842448113979 ()


  • Dental implant system
3.3mm Diameter, 4.8mm Platform TG Implant Length 12mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG12R1
In Commercial Distribution

  • 00842448113962 ()


  • Dental implant system
3.3mm Diameter, 4.8mm Platform TG Implant Length 10mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG10S1
In Commercial Distribution

  • 00842448113955 ()


  • Dental implant system
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