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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Scanner Sleeves
Align Technology, Inc.
204284
In Commercial Distribution

  • 00816063020615 ()


  • Dental milling system, CAD/CAM, chairside
Scanner Sleeve
Align Technology, Inc.
209174
In Commercial Distribution

  • 00816063020608 ()


  • Dental milling system, CAD/CAM, chairside
Scanner Sleeve
Align Technology, Inc.
109236
In Commercial Distribution

  • 00816063020585 ()


  • Dental milling system, CAD/CAM, chairside
Scanner Upgrade Kit
Align Technology, Inc.
206856
In Commercial Distribution

  • 00816063020578 ()


  • Dental milling system, CAD/CAM, chairside
Scanner Upgrade Kit
Align Technology, Inc.
206855
In Commercial Distribution

  • 00816063020561 ()


  • Dental milling system, CAD/CAM, chairside
Scanner
Align Technology, Inc.
206160
In Commercial Distribution

  • 00816063020509 ()


  • Dental milling system, CAD/CAM, chairside
Scanner
Align Technology, Inc.
205929
In Commercial Distribution

  • 00816063020493 ()


  • Dental milling system, CAD/CAM, chairside
Scanner
Align Technology, Inc.
202964
In Commercial Distribution

  • 00816063020295 ()


  • Dental milling system, CAD/CAM, chairside
No Description
Align Technology, Inc.
202965
In Commercial Distribution

  • 00816063020288 ()


  • Dental milling system, CAD/CAM, chairside
Scanner
Align Technology, Inc.
108064
In Commercial Distribution

  • 00816063020141 ()


  • Dental milling system, CAD/CAM, chairside
Scanner
Align Technology, Inc.
108063
In Commercial Distribution

  • 00816063020134 ()


  • Dental milling system, CAD/CAM, chairside
PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
PERIGEN SOLUTIONS LTD
2024.2.xxx
In Commercial Distribution

  • B087PATT202421 ()


  • Obstetrical monitoring/analysis software
PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
PERIGEN SOLUTIONS LTD
2024.1.xxx
In Commercial Distribution

  • B087PATT202411 ()


  • Obstetrical monitoring/analysis software
PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
PERIGEN SOLUTIONS LTD
2022.2.xxx
In Commercial Distribution

  • B087PATT202221 ()


  • Obstetrical monitoring/analysis software
PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
PERIGEN SOLUTIONS LTD
02.12.xx
In Commercial Distribution

  • B087PATT02121 ()


  • Obstetrical monitoring/analysis software
PeriWatch™ Vigilance™ Cues™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at ≥36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
PERIGEN SOLUTIONS LTD
02.10.xx
In Commercial Distribution

  • B087PATT02101 ()


  • Obstetrical monitoring/analysis software
PeriWatch™ Cues™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
PERIGEN SOLUTIONS LTD
02.08.xx
In Commercial Distribution

  • B087PATT02081 ()


  • Obstetrical monitoring/analysis software
PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
PERIGEN SOLUTIONS LTD
02.06.00
In Commercial Distribution

  • B087PATT02061 ()


  • Obstetrical monitoring/analysis software
PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
PERIGEN SOLUTIONS LTD
02.04.xx
In Commercial Distribution

  • B087PATT02041 ()


  • Obstetrical monitoring/analysis software
PeriCALM® CheckList™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
PERIGEN SOLUTIONS LTD
01.02.00
In Commercial Distribution

  • B087PATCL01021 ()


  • Obstetrical monitoring/analysis software
PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
PERIGEN SOLUTIONS LTD
21.01.xx
In Commercial Distribution

  • B087HUB21011 ()


  • Obstetrical monitoring/analysis software
PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
PERIGEN SOLUTIONS LTD
2024.1.xxx
In Commercial Distribution

  • B087HUB202411 ()


  • Obstetrical monitoring/analysis software
PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
PERIGEN SOLUTIONS LTD
2022.2.xxx
In Commercial Distribution

  • B087HUB202221 ()


  • Obstetrical monitoring/analysis software
PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
PERIGEN SOLUTIONS LTD
01.05.xx
In Commercial Distribution

  • B087HUB01051 ()


  • Obstetrical monitoring/analysis software
PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
PERIGEN SOLUTIONS LTD
01.04.xx
In Commercial Distribution

  • B087HUB01041 ()


  • Obstetrical monitoring/analysis software
PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
PERIGEN SOLUTIONS LTD
01.03.xx
In Commercial Distribution

  • B087HUB01031 ()


  • Obstetrical monitoring/analysis software
PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
PERIGEN SOLUTIONS LTD
01.01.xx
In Commercial Distribution

  • B087HUB01011 ()


  • Obstetrical monitoring/analysis software
PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is >= 35 weeks.
PERIGEN SOLUTIONS LTD
2024.1.xxx
In Commercial Distribution

  • B087CURV202411 ()


  • Obstetrical monitoring/analysis software
PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is >= 35 weeks.
PERIGEN SOLUTIONS LTD
2022.2.xxx
In Commercial Distribution

  • B087CURV202221 ()


  • Obstetrical monitoring/analysis software
PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is >= 35 weeks.
PERIGEN SOLUTIONS LTD
02.12.xx
In Commercial Distribution

  • B087CURV02121 ()


  • Obstetrical monitoring/analysis software
PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks.
PERIGEN SOLUTIONS LTD
02.10.xx
In Commercial Distribution

  • B087CURV02101 ()


  • Obstetrical monitoring/analysis software
PeriWatch Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks.
PERIGEN SOLUTIONS LTD
02.08.xx
In Commercial Distribution

  • B087CURV02081 ()


  • Obstetrical monitoring/analysis software
PeriCALM Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks.
PERIGEN SOLUTIONS LTD
02.06.00
In Commercial Distribution

  • B087CURV02061 ()


  • Obstetrical monitoring/analysis software
PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
PERIGEN SOLUTIONS LTD
01.00.xx
In Commercial Distribution

  • B087VIGILANCE01001 ()


  • Obstetrical monitoring/analysis software
PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
PERIGEN SOLUTIONS LTD
03.18.04
In Commercial Distribution

  • B087TRAC03181 ()


  • Obstetrical monitoring/analysis software
PeriWatch Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks.
PERIGEN SOLUTIONS LTD
02.10.xx
In Commercial Distribution

  • B087PWCURV02101 ()


  • Obstetrical monitoring/analysis software
PeriWatch® Cues™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at ≥36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
PERIGEN SOLUTIONS LTD
02.10.xx
In Commercial Distribution

  • B087PWCUES02101 ()


  • Obstetrical monitoring/analysis software
PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
PERIGEN SOLUTIONS LTD
02.08.xx
In Commercial Distribution

  • B087PATTERNS02081 ()


  • Obstetrical monitoring/analysis software
PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
PERIGEN SOLUTIONS LTD
22.01.xx
In Commercial Distribution

  • B087PATT22011 ()


  • Obstetrical monitoring/analysis software
PeriWatch Vigilance Cues is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >=36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
PERIGEN SOLUTIONS LTD
21.01.xx
In Commercial Distribution

  • B087PATT21011 ()


  • Obstetrical monitoring/analysis software
PeriCALM® Patterns™ is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at >36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
PERIGEN SOLUTIONS LTD
02.02.10
In Commercial Distribution

  • B087PATT02021 ()


  • Obstetrical monitoring/analysis software
PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
PERIGEN SOLUTIONS LTD
22.01.xx
In Commercial Distribution

  • B087HUB22011 ()


  • Obstetrical monitoring/analysis software
PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
PERIGEN SOLUTIONS LTD
2024.2.xxx
In Commercial Distribution

  • B087HUB202421 ()


  • Obstetrical monitoring/analysis software
PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
PERIGEN SOLUTIONS LTD
01.02.xx
In Commercial Distribution

  • B087HUB01021 ()


  • Obstetrical monitoring/analysis software
PeriCALM® Tracings™ is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
PERIGEN SOLUTIONS LTD
01.00.xx
In Commercial Distribution

  • B087HUB01001 ()


  • Obstetrical monitoring/analysis software
PeriCALM Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks.
PERIGEN SOLUTIONS LTD
02.08.xx
In Commercial Distribution

  • B087CURVE02081 ()


  • Obstetrical monitoring/analysis software
PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is >= 35 weeks.
PERIGEN SOLUTIONS LTD
22.01.xx
In Commercial Distribution

  • B087CURV22011 ()


  • Obstetrical monitoring/analysis software
PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is >= 35 weeks.
PERIGEN SOLUTIONS LTD
21.01.xx
In Commercial Distribution

  • B087CURV21011 ()


  • Obstetrical monitoring/analysis software
PeriWatch Vigilance Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is >= 35 weeks.
PERIGEN SOLUTIONS LTD
2024.2.xxx
In Commercial Distribution

  • B087CURV202421 ()


  • Obstetrical monitoring/analysis software
fastscan.io Intraoral Scanner
Prismatik Dentalcraft, Inc
70-1181-MIL0152
Not in Commercial Distribution

  • D745701181MIL01520 ()
70-1181-MIL0152

  • Dental milling system, CAD/CAM, chairside
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