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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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
MA9140 IOS (Version 12)
In Commercial Distribution

  • 00300021175559 ()
MA9140001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
Care Assist
Philips Medical Systems Hsg
Care Assist iOS 4.2
In Commercial Distribution

  • 00884838123717 ()
989803221531

  • Centralized patient monitor
No Description
AUGMEDICS LTD
ASP07070
In Commercial Distribution

  • 27290113781195 ()
  • 17290113781181 ()


  • Multi-purpose stereotactic surgery system
No Description
AUGMEDICS LTD
ASP07073
In Commercial Distribution

  • 27290113781164 ()
  • 17290113781150 ()


  • Multi-purpose stereotactic surgery system
No Description
AUGMEDICS LTD
ASP07059
In Commercial Distribution

  • 27290113781041 ()
  • 17290113781044 ()


  • Multi-purpose stereotactic surgery system
No Description
AUGMEDICS LTD
ASP07056
In Commercial Distribution

  • 27290113781034 ()
  • 17290113781037 ()


  • Multi-purpose stereotactic surgery system
The Ballancer Pro Pants-Bot. conn inflatable garment is fills and deflates, applying a directional compress-and-release massage. This soothing massage action temporarily increases circulation in the areas to which the garment is applied, and temporarily relieves muscle aches and pain caused by fatigue or overexertion.
MEGO afek Agricultural Cooperative Society Ltd
Bal Pants Bot conn
In Commercial Distribution

  • 07290105874191 ()
L4MP4120

  • Multi-chamber venous compression system garment, reusable
No Description
Lonza Walkersville, Inc.
04-1149Q
In Commercial Distribution

  • 00840075401100 ()
04-1149Q

  • Ex vivo cell culture medium
VALIDATE THY2 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated instrument systems for the following analytes: Tg Set: Thyroglobulin (Tg) TU Set: T-Uptake (TU)
Lgc Clinical Diagnostics, Inc.
908bc
In Commercial Distribution

  • 00850011135372 ()


  • Thyroglobulin IVD, control
  • Multiple thyroid hormone uptake (T-uptake) IVD, control
Thyroglobulin CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388175
In Commercial Distribution

  • 00630414979472 ()
LTYCVM

  • Thyroglobulin antibody IVD, control
Thyreoglobulin - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381638
In Commercial Distribution

  • 00630414972077 ()
LKTY1(D)

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
Positioning premature infants is a major challenge in intensive care. Newborn babies in general, but especially premature babies, are less active and often lie in one position. As a result, certain body parts are exposed to increased pressure. As the bones of the skull are still very soft in the first months of life, the head is sensitive to permanent pressure. This is particularly critical for premature babies, as the skull is still softer due to the low maturity at birth. Premature babies often have to be monitored in the hospital for several months and also have to stay in an incubator. Head deformations, such as plagiocephaly, brachycephaly and dolichocephaly, are often the result of unilateral positioning of premature and newborn babies on their sides or backs. In studies, the incidence of head deformations in premature babies is reported to be up to 90 %. With the Medibino Neo positioning system, we provide a solution for pressure-relieving positioning and stabilisation of the mid-head position of premature babies and infants during long hospital stays.
Kluba Medical GmbH
1
In Commercial Distribution

  • 04260764840724 ()
  • 04260764840571 ()

  • Fits for premature infants weighting 200-800g
24021703-S

  • Infant recumbent sleep positioner
Positioning premature infants is a major challenge in intensive care. Newborn babies in general, but especially premature babies, are less active and often lie in one position. As a result, certain body parts are exposed to increased pressure. As the bones of the skull are still very soft in the first months of life, the head is sensitive to permanent pressure. This is particularly critical for premature babies, as the skull is still softer due to the low maturity at birth. Premature babies often have to be monitored in the hospital for several months and also have to stay in an incubator. Head deformations, such as plagiocephaly, brachycephaly and dolichocephaly, are often the result of unilateral positioning of premature and newborn babies on their sides or backs. In studies, the incidence of head deformations in premature babies is reported to be up to 90 %. With the Medibino Neo positioning system, we provide a solution for pressure-relieving positioning and stabilisation of the mid-head position of premature babies and infants during long hospital stays.
Kluba Medical GmbH
1
In Commercial Distribution

  • 04260764840564 ()
  • 04260764840717 ()

  • Fits for premature infants weighting 800-2000g
24021703-M

  • Infant recumbent sleep positioner
Compatible with Dentsply Sirona XiVE MP _ TG White Metal Scanmarker consisting of: 1x White Metal Scanmarker L15 1x White Metal Scanmarker Screw
ZIRKONZAHN SRL
ZBED4034L15
In Commercial Distribution

  • D800ZBED4034L15 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG White Metal Scanmarker consisting of: 1x White Metal Scanmarker L12 1x White Metal Scanmarker Screw
ZIRKONZAHN SRL
ZBED4034L12
In Commercial Distribution

  • D800ZBED4034L12 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG White Metal Scanmarker consisting of: 1x White Metal Scanmarker L15 1x White Metal Scanmarker Screw
ZIRKONZAHN SRL
ZBED4033L15
In Commercial Distribution

  • D800ZBED4033L15 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG White Metal Scanmarker consisting of: 1x White Metal Scanmarker L12 1x White Metal Scanmarker Screw
ZIRKONZAHN SRL
ZBED4033L12
In Commercial Distribution

  • D800ZBED4033L12 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG White Metal Scanmarker consisting of: 1x White Metal Scanmarker L15 1x White Metal Scanmarker Screw
ZIRKONZAHN SRL
ZBED4032L15
In Commercial Distribution

  • D800ZBED4032L15 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG White Metal Scanmarker consisting of: 1x White Metal Scanmarker L12 1x White Metal Scanmarker Screw
ZIRKONZAHN SRL
ZBED4032L12
In Commercial Distribution

  • D800ZBED4032L12 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG White Metal Scanmarker consisting of: 1x White Metal Scanmarker L15 1x White Metal Scanmarker Screw
ZIRKONZAHN SRL
ZBED4031L15
In Commercial Distribution

  • D800ZBED4031L15 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG White Metal Scanmarker consisting of: 1x White Metal Scanmarker L12 1x White Metal Scanmarker Screw
ZIRKONZAHN SRL
ZBED4031L12
In Commercial Distribution

  • D800ZBED4031L12 ()


  • Dental implant suprastructure, temporary, preformed, reusable
The Glooko Mobile application for iOS and Android displays retrospective data that is captured from BG meters, insulin pumps and continuous glucose monitors (CGM)
GLOOKO, INC.
5.xx
In Commercial Distribution

  • 00855093008033 ()


  • Clinical management support software
The ZEUS AtheNA Multi-Lyte® TPO/Tg Plus Test System is intended for the quantitative detection of IgG class antibody to 2 separate Thyroid Antigens; Thyroid Peroxidase (TPO) and Thyroglobulin (Tg), in human serum. The test system is intended to be used as an aid in the diagnosis of various autoimmune thyroid diseases. This test is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
A51101
In Commercial Distribution

  • 00845533000109 ()
A51101

  • Multiple thyroid antibody IVD, kit, fluorescent immunoassay
Positioning premature infants is a major challenge in intensive care. Newborn babies in general, but especially premature babies, are less active and often lie in one position. As a result, certain body parts are exposed to increased pressure. As the bones of the skull are still very soft in the first months of life, the head is sensitive to permanent pressure. This is particularly critical for premature babies, as the skull is still softer due to the low maturity at birth. Premature babies often have to be monitored in the hospital for several months and also have to stay in an incubator. Head deformations, such as plagiocephaly, brachycephaly and dolichocephaly, are often the result of unilateral positioning of premature and newborn babies on their sides or backs. In studies, the incidence of head deformations in premature babies is reported to be up to 90 %. With the Medibino Neo positioning system, we provide a solution for pressure-relieving positioning and stabilisation of the mid-head position of premature babies and infants during long hospital stays.
Kluba Medical GmbH
1
In Commercial Distribution

  • 04260764840700 ()
  • 04260764840557 ()

  • Fits for premature infants weighting more than 2000g
24021703-L

  • Infant recumbent sleep positioner
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 Introductory Access Limited Version provides limited access to the reSET-O product.
PEAR THERAPEUTICS, INC.
1
Not in Commercial Distribution

  • 10851580008170 ()


  • 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 Introductory Access Limited Version provides limited access to the reSET product.
PEAR THERAPEUTICS, INC.
1
Not in Commercial Distribution

  • 10851580008149 ()


  • Mental health/function therapeutic software, screen-viewed
No Description
STARKEY LABORATORIES, INC.
Thrive Hearing Control for iOS
In Commercial Distribution

  • 00842318130792 ()


  • Audiometric/hearing device software
Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Apple iOS operating system.
RM SPEECH
RMNXS
In Commercial Distribution

  • B660RMNXS0 ()


  • Voice synthesizer/digitizer
Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Apple iOS operating system.
RM SPEECH
RMNXL
In Commercial Distribution

  • B660RMNXL0 ()


  • Voice synthesizer/digitizer
Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Apple iOS operating system.
RM SPEECH
RMNS
In Commercial Distribution

  • B660RMNS0 ()


  • Voice synthesizer/digitizer
Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Apple iOS operating system.
RM SPEECH
RMN
In Commercial Distribution

  • B660RMN0 ()


  • Voice synthesizer/digitizer
The Bal. Pro Pants-Bot. conn w/o print inflatable garment is fills and deflates, applying a directional compress-and-release massage. This soothing massage action temporarily increases circulation in the areas to which the garment is applied, and temporarily relieves muscle aches and pain caused by fatigue or overexertion.
MEGO afek Agricultural Cooperative Society Ltd
Bal Pants Bot conn NP
In Commercial Distribution

  • 07290105875051 ()
L4MP4122

  • Multi-chamber venous compression system garment, reusable
Sterlization Container, 1/1 bottom perforated 585x274x116 mm
SBH Surgical
SB 106.135E - Non Perforated Bot.
In Commercial Distribution

  • 00850068304219 ()
SB 106.135E

  • Device sterilization/disinfection container, reusable
No Description
NT-Trading GmbH & Co. KG
UTG 605000
Not in Commercial Distribution

  • ENTTUTG6050001 ()

  • Diameter: Ø 5,0 mm Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG 605000

  • Dental implant suprastructure, permanent, preformed
  • Dental prosthesis/implant abutment screw
No Description
NT-Trading GmbH & Co. KG
UTG 80500000
Not in Commercial Distribution

  • ENTTUTG805000001 ()

  • Diameter: Ø 5,0 mm Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG 80500000

  • Dental implant suprastructure, permanent, preformed
  • Dental prosthesis/implant abutment screw
Thyroglobulin Sample Diluent - IMMULITE -- 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387046
In Commercial Distribution

  • 00630414954301 ()
LTYZ

  • Buffered sample diluent IVD
Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Glooko MIDS Mobile Application is only available to patients who have been prescribed MIDS by their heath care provider. The mobile application can be downloaded by patients from the Google Play Store for Android and from the Apple App Store for iOS operating systems.
GLOOKO, INC.
5.x
In Commercial Distribution

  • 00855093008002 ()


  • Clinical management support software
Reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoantibodies: anti-thyroperoxidase TPO , anti-thyroglobulin TG , anti- TSH receptor R-TSH .
THERADIAG SA
THYRO
In Commercial Distribution

  • 03760170782072 ()
HM 065US-2X05

  • Multiple thyroid antibody IVD, control
Compatible with Dentsply Sirona XiVE MP _ TG Set consisting of: 1x Impression coping NON HEX 1x Screw for Impression coping 1x Cap for Impression coping closed tray
ZIRKONZAHN SRL
BSAQ4074
In Commercial Distribution

  • D800BSAQ4074 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG Set consisting of: 1x Impression coping NON HEX 1x Screw for Impression coping 1x Cap for Impression coping closed tray
ZIRKONZAHN SRL
BSAQ4073
In Commercial Distribution

  • D800BSAQ4073 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG Set consisting of: 1x Impression coping NON HEX 1x Screw for Impression coping 1x Cap for Impression coping closed tray
ZIRKONZAHN SRL
BSAQ4072
In Commercial Distribution

  • D800BSAQ4072 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG Set consisting of: 1x Impression coping NON HEX 1x Screw for Impression coping 1x Cap for Impression coping closed tray
ZIRKONZAHN SRL
BSAQ4071
In Commercial Distribution

  • D800BSAQ4071 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG Set consisting of: 1x Impression coping NON HEX 1x Screw for Impression coping 1x Driver for Impression coping open tray
ZIRKONZAHN SRL
BSAQ4064
In Commercial Distribution

  • D800BSAQ4064 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG Set consisting of: 1x Impression coping NON HEX 1x Screw for Impression coping 1x Driver for Impression coping open tray
ZIRKONZAHN SRL
BSAQ4063
In Commercial Distribution

  • D800BSAQ4063 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG Set consisting of: 1x Impression coping NON HEX 1x Screw for Impression coping 1x Driver for Impression coping open tray
ZIRKONZAHN SRL
BSAQ4062
In Commercial Distribution

  • D800BSAQ4062 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Dentsply Sirona XiVE MP _ TG Set consisting of: 1x Impression coping NON HEX 1x Screw for Impression coping 1x Driver for Impression coping open tray
ZIRKONZAHN SRL
BSAQ4061
In Commercial Distribution

  • D800BSAQ4061 ()


  • Dental implant suprastructure, temporary, preformed, reusable
The Access Thyroglobulin Sample Diluent is intended for use with the Access Thyroglobulin Assay to dilute patient samples containing thyroglobulin (Tg) concentrations greater than the S5 calibrator.
Beckman Coulter, Inc.
33866
In Commercial Distribution

  • 15099590225858 ()
33866

  • Thyroglobulin IVD, kit, chemiluminescent immunoassay
No Description
NT-Trading GmbH & Co. KG
UTG 80334200
Not in Commercial Distribution

  • ENTTUTG803342001 ()

  • Diameter: Ø 3,3 - 4,25 mm Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG 80334200

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
No Description
NT-Trading GmbH & Co. KG
UTG 603342
Not in Commercial Distribution

  • ENTTUTG6033421 ()

  • Diameter: Ø 3,3 - 4,25 mm Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG 603342

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
TraumaGuard Intra-abdominal Pressure-Sensing Catheter (“TG”). TG is a urine drainage catheter that provides continuous biometric monitoring of Intra-abdominal Pressure (“IAP”) and Core Body Temperature (CBT). TG is a silicone catheter with polyurethane sensing balloons. IAP UO Temp is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The TraumaGuard Intra-abdominal Pressure-Sensing System Catheter is a single-use device intended for short-term use (less than 30 days).
SENTINEL MEDICAL TECHNOLOGIES
TraumaGuard Intra-abdominal Pressure-Sensing System Single Catheter
In Commercial Distribution

  • 00860003478707 ()
000-0219

  • Multi-parameter urinary monitoring system catheter set
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