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
EMPATICA SRL
Care App iOS
In Commercial Distribution

  • 00853858006249 ()


  • Multiple vital physiological parameter monitoring system, home-use
No Description
Ouraring Inc.
Fertile Window iOS
In Commercial Distribution

  • 06430060159990 ()


  • Menstrual cycle self-monitoring software
No Description
Phillips-Medisize A/S
iOS (Mobile App)
Not in Commercial Distribution

  • 05713495000053 ()
84601063

  • Medication reminder application software
Care Assist
Philips Medizin Systeme Böblingen GmbH
Care Assist iOS
In Commercial Distribution

  • 00884838127432 ()
989803221531

  • Centralized patient monitor
Software as a Medical Device (SaMD) which operates as a medication reminder and support services; Operates on Apple iOS devices.
Astellas Pharma Us, Inc.
iOS (Version 1)
In Commercial Distribution

  • 00304692416089 ()
DIGI-001

  • Medication reminder application software
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals. It is available for prescription only.
SUBLIMED
actiTENS iOS app
In Commercial Distribution

  • B786SBM2AA2100 ()
SBM2AA210

  • Analgesic transcutaneous electrical nerve stimulation system
myDigitalKnee mobile app is used with a Digital Knee sensor attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition.
OPUM TECHNOLOGIES SERVICES LIMITED
Mobile App iOS
In Commercial Distribution

  • 09413000126259 ()


  • Electronic goniometer/kinesiology sensor
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
No Description
Philips Ultrasound LLC
795160
In Commercial Distribution

  • 00884838103399 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
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
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
In Commercial Distribution

75750

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

  • 00630414954523 ()
LTYRM

  • Thyroglobulin IVD, reagent
No Description
MONOBIND, INC.
2225-300
In Commercial Distribution

  • 00816870021775 ()

  • Width: 7.75 Inch
2225-300B

  • Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)
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