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
AUGMEDICS LTD
AHMD601CLT
In Commercial Distribution

  • 17290113781327 ()
  • 07290113781313 ()


  • Multi-purpose stereotactic surgery system
No Description
AUGMEDICS LTD
AHMD681CLD
In Commercial Distribution

  • 17290113781303 ()
  • 07290113781290 ()


  • Multi-purpose stereotactic surgery system
No Description
AUGMEDICS LTD
AHMD641CLD
In Commercial Distribution

  • 17290113781280 ()
  • 07290113781276 ()


  • Multi-purpose stereotactic surgery system
No Description
AUGMEDICS LTD
AHMD601CLD
In Commercial Distribution

  • 07290113781252 ()
  • 17290113781266 ()


  • Multi-purpose stereotactic surgery system
No Description
AUGMEDICS LTD
ASP00027
In Commercial Distribution

  • 07290113780293 ()


  • Multi-purpose stereotactic surgery system
No Description
AUGMEDICS LTD
ASP00011
In Commercial Distribution

  • 07290113780286 ()


  • Multi-purpose stereotactic surgery system
Compatible with Dentsply Sirona XiVE MP _ TG Consisting of: 1x Screw for impression copings
ZIRKONZAHN SRL
BSFE4004
In Commercial Distribution

  • D800BSFE4004 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG Consisting of: 1x Screw for impression copings
ZIRKONZAHN SRL
BSFE4003
In Commercial Distribution

  • D800BSFE4003 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG Consisting of: 1x Screw for impression copings
ZIRKONZAHN SRL
BSFE4002
In Commercial Distribution

  • D800BSFE4002 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG Consisting of: 1x Screw for impression copings
ZIRKONZAHN SRL
BSFE4001
In Commercial Distribution

  • D800BSFE4001 ()


  • Dental implant suprastructure, temporary, preformed, reusable
No Description
Lonza Verviers
BESP1649Q
In Commercial Distribution

  • 05407010123968 ()
BESP1649Q

  • Ex vivo cell culture medium
No Description
Lonza Walkersville, Inc.
04-1167Q
In Commercial Distribution

  • 00840075402626 ()
04-1167Q

  • Ex vivo cell culture medium
No Description
Lonza Walkersville, Inc.
04-1150Q
In Commercial Distribution

  • 00840075401230 ()
04-1150Q

  • Ex vivo cell culture medium
Thyreoglobulin - IMMULITE - CONS - 3x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385247
In Commercial Distribution

  • 00630414978345 ()
LTYCM(D)

  • Thyroglobulin IVD, control
Thyreoglobulin - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381647
In Commercial Distribution

  • 00630414972084 ()
L2KTY2(D)

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality worklist • Capture videos, images and audio files to be included in the study case. • Add notes and tags to each file (asset). • Upload any file to the Orpheus System • Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025100 ()
MLL-EG30001

  • Radiology information system application software
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
In Commercial Distribution

75750

  • Rectal irrigation system application software
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
Not in Commercial Distribution

  • 07392532242373 ()
75750

  • Rectal irrigation system application software
No Description
Thought Technology Ltd.
SA4515
In Commercial Distribution

  • 07540191000630 ()


  • Psychophysiological biofeedback system
Eversense NOW Remote Monitoring mobile application (iOS) is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information.
SENSEONICS, INCORPORATED
FG-5901-01-300
In Commercial Distribution

  • 00817491021267 ()
FG-5901-01-300

  • Implantable glucose monitoring system
Accessories
CeramTec Schweiz GmbH
301291
In Commercial Distribution

  • 07640161395015 ()
301291

  • Dental implant suprastructure, temporary, preformed, single-use
No Description
Philips Ultrasound LLC
795160
In Commercial Distribution

  • 00884838103399 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
Curing Light
Guilin Woodpecker Medical Instrument Co., Ltd.
LUX E简约版
In Commercial Distribution

  • 06944843602189 ()


  • Dental/surgical polymerization lamp
A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroglobulin(Tg) in human serum.
KRONUS, INC.
KR6275
In Commercial Distribution

  • B126KR62750 ()
KR6275

  • Thyroglobulin antibody IVD, kit, radioimmunoassay
A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroglobulin(Tg) in human serum.
KRONUS, INC.
KR6270
In Commercial Distribution

  • B126KR62700 ()
KR6270

  • Thyroglobulin antibody IVD, kit, radioimmunoassay
No Description
AUGMEDICS LTD
ASP00046
In Commercial Distribution

  • 27290113780976 ()
  • 17290113780979 ()
  • 07290113780972 ()


  • Multi-purpose stereotactic surgery system
No Description
CENTER HEALTH INCORPORATED
TD-4140
In Commercial Distribution

  • 00860003222317 ()


  • Glucose IVD, kit, electrometry
No Description
Lonza Walkersville, Inc.
04-1055F
In Commercial Distribution

  • 00840075401049 ()


  • Ex vivo cell culture medium
No Description
Lonza Walkersville, Inc.
04-1135Q
In Commercial Distribution

  • 00840075400363 ()
04-1135Q

  • Ex vivo cell culture medium
No Description
MONOBIND, INC.
2275-300
In Commercial Distribution

  • 00816870023212 ()

  • Width: 7.75 Inch
2275-300B

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
No Description
MONOBIND, INC.
2275-300
In Commercial Distribution

  • 00816870023205 ()

  • Width: 7.75 Inch
2275-300A

  • Thyroglobulin IVD, kit, chemiluminescent immunoassay
No Description
MONOBIND, INC.
2225-300
In Commercial Distribution

  • 00816870021768 ()

  • Width: 7.75 Inch
2225-300A

  • Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
2225-300
In Commercial Distribution

  • 00816870021775 ()

  • Width: 7.75 Inch
2225-300B

  • Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)
Thyreoglobulin Recovery Sample - IMMULITE - CONS - 80 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381639
In Commercial Distribution

  • 00630414954523 ()
LTYRM

  • Thyroglobulin IVD, reagent
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.
SM2Z5061G
In Commercial Distribution

  • 00845533001182 ()
SM2Z5061G

  • Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA)
The Quantitative Determination of Thyroglobulin (Tg) Autoantibodies in Human Serum or Plasma by a Microplate Enzyme Immunoassay, Colorimetric.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-4110
In Commercial Distribution

  • 04048474041101 ()
EIA-4110

  • Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA)
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 Demo Version provides demonstration access to various prescription versions of the reSET-O product and is not intended for patients.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008231 ()


  • 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 Demo Version provides demonstration access to various prescription versions of the reSET product and is not intended for patients.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008200 ()


  • Mental health/function therapeutic software, screen-viewed
The Wavely Middle Ear Fluid Scanner utilizes the WavelyDx Middle Ear Fluid CMD iOS Application, the mobile software, used in conjunction with the Wavely Ear Tip. The Wavely Middle Ear Fluid Scanner turns a smartphone into an acoustic reflectometer, which uses sound waves to accurately detect the presence of middle ear fluid that may be associated with acute ear infection.
Wavely Diagnostics, Inc.
SWA-1262
In Commercial Distribution

  • 00860007953712 ()
SWA-1262

  • Impedance audiometer
Accessories
CeramTec Schweiz GmbH
301251
In Commercial Distribution

  • 07640161394780 ()
301251

  • Dental implant suprastructure, temporary, preformed, single-use
Accessories
CeramTec Schweiz GmbH
301250
In Commercial Distribution

  • 07640161394773 ()
301250

  • Dental implant suprastructure, temporary, preformed, single-use
Accessories
CeramTec Schweiz GmbH
301249
In Commercial Distribution

  • 07640161394766 ()
301249

  • Dental implant suprastructure, temporary, preformed, single-use
The Quantitative Determination of Thyroglobulin (Tg) Autoantibodies in Human Serum or Plasma by a Microplate Enzyme Immunoassay, Colorimetric. Measurements of Tg autoantibodies may aid in the diagnosis of certain thyroid diseases such as Hashimoto’s and Grave’s as well as nontoxic goiter.
DRG International Inc
EIA-4110
In Commercial Distribution

  • 00840239041104 ()

  • Total Volume: 20 Milliliter
  • Wash Solution
  • Calibrators
  • Total Volume: 13 Milliliter
  • Stop Solution
  • Total Volume: 1 Milliliter
  • Substrate B
  • Biotin Reagent
  • Substrate A
  • Total Volume: 7 Milliliter
  • Enzyme Reagent
  • Total Volume: 8 Milliliter
  • Serum Diluent
EIA-4110

  • Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA)
The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries. System includes five TST-11 tips.
3shape Trios A/S
L1P-1F
In Commercial Distribution

  • 05902729753722 ()


  • Intraoral optical scanning system
No Description
STARKEY LABORATORIES, INC.
“ProAkustik name” for iOS
In Commercial Distribution

  • 00842318130839 ()


  • Audiometric/hearing device software
No Description
STARKEY LABORATORIES, INC.
“KIND name” for iOS
In Commercial Distribution

  • 00842318130815 ()


  • Audiometric/hearing device software
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
MA9142 IOS (Version 17)
In Commercial Distribution

  • 00300021451554 ()
MA9142001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
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
MA9162 IOS (Version 15)
In Commercial Distribution

  • 00300021286552 ()
MA9162001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
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
MA9160 IOS (Version 14)
In Commercial Distribution

  • 00300021284558 ()
MA9160001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
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
MA9158 IOS (Version 13)
In Commercial Distribution

  • 00300021177553 ()
MA9158001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
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