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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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
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
No Description
Philips Ultrasound LLC
795160
In Commercial Distribution

  • 00884838103399 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
Accessories
CeramTec Schweiz GmbH
301291
In Commercial Distribution

  • 07640161395015 ()
301291

  • Dental implant suprastructure, temporary, preformed, single-use
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
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
Not in Commercial Distribution

  • 07392532242373 ()
75750

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

  • 07540191000630 ()


  • Psychophysiological biofeedback system
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
In Commercial Distribution

75750

  • Rectal irrigation system application software
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
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
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)
Thyreoglobulin Recovery Sample - IMMULITE - CONS - 80 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381639
In Commercial Distribution

  • 00630414954523 ()
LTYRM

  • Thyroglobulin IVD, reagent
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