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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The X-VS sensor is intended to capture intraoral digital images when exposed to X-Rays.
CEFLA SOCIETA' COOPERATIVA
X-VS
In Commercial Distribution

  • 08033837931850 ()
XSENSONEWTOM

  • Dental digital imaging sensor, intraoral
BOT TRAY TIB/PAT CASE
Exactech, Inc.
201-55-34
In Commercial Distribution

  • 10885862043795 ()
201-55-34

  • Instrument tray, reusable
HYH SHOULDER BOT. W/CON
O&M HALYARD, INC.
05018
In Commercial Distribution

  • 30680651050183 ()
  • 10680651050189 ()
76094-ACM5018

  • Patient surgical drape, single-use
CURRETTE #6, -5DEGREE BOT BEND
Orthofix US LLC
46-1001
In Commercial Distribution

  • 18257200040094 ()


  • Metallic spinal interbody fusion cage
Salvin TG Driver
SALVIN DENTAL SPECIALTIES, LLC
TG
In Commercial Distribution

  • 00841336111530 ()
TG

  • Dental torque wrench
TG RATCHET ADAPTER
BIOMET 3I, LLC
MDR10H
Not in Commercial Distribution

  • 00844868010098 ()


  • Surgical screwdriver, reusable
IOS external fixator system (short)
METAPHYSIS LLP
2-0-0S
In Commercial Distribution

  • 05060309872017 ()


  • External orthopaedic fixation system, single-use
IOS external fixator system (Long)
METAPHYSIS LLP
2-0-0L
In Commercial Distribution

  • 05060309872000 ()


  • External orthopaedic fixation system, single-use
LOW VOL, PRE-PUMP BOT CHAMBER 6.35MM
B. BRAUN MEDICAL INC.
B3-6605M6792
Not in Commercial Distribution

  • 04046955348879 ()
  • 04046955348886 ()
B3-6605M6792

  • Haemodialysis blood tubing set, single-use
BOT TRAY FEM 2 INST CASE
Exactech, Inc.
201-55-23
In Commercial Distribution

  • 10885862238849 ()
201-55-23

  • Instrument tray, reusable
ASICO ANGLED DIAMOND CRESENT BEVEL BOT
KATENA PRODUCTS, INC.
AE-8152
In Commercial Distribution

  • 00841668141564 ()
AE-8152

  • Ophthalmic knife, reusable
INSTRUMENT 8981400 2PRNG 15DEG ZERO BOT
MEDTRONIC SOFAMOR DANEK, INC.
8981400
In Commercial Distribution

  • 00721902575570 ()


  • Orthopaedic surgical distractor, internal
CoRoent XL-F Instrument Tray (Bot Tray)
Nuvasive, Inc.
5450063
In Commercial Distribution

  • 00887517247964 ()


  • Device sterilization/disinfection container, reusable
ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted GE Platform
Bot Image, Inc.
ProstatID™
In Commercial Distribution

  • 00860009082625 ()


  • MRI image interpretive software
ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted On-Premise
Bot Image, Inc.
ProstatID™
In Commercial Distribution

  • 00860009082618 ()
580SW.01

  • MRI image interpretive software
ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted Terrarecon Platform
Bot Image, Inc.
ProstatID™
In Commercial Distribution

  • 00860009082601 ()


  • MRI image interpretive software
iOS
RESMED PTY LTD
22243
In Commercial Distribution

  • 00619498222438 ()


  • Ventilator application software
TG
Zoll-Dental
PC-TG
In Commercial Distribution

  • 00840105209829 ()


  • Periodontal hoe
MasterScreen IOS
Jaeger Medical GmbH
V-176420
In Commercial Distribution

  • 04250892905631 ()
V-176420

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176420-13
In Commercial Distribution

  • 04250892905259 ()
V-176420-13

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
176450-13
In Commercial Distribution

  • 04250892905242 ()
176450-13

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
176400
In Commercial Distribution

  • 04250892905235 ()
176400

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
176400
Not in Commercial Distribution

  • 04250892900452 ()
176400

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176400-03
Not in Commercial Distribution

  • 04250892900438 ()
V-176400-03

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-376406
In Commercial Distribution

  • 04250892905808 ()
V-376406

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
176400
Not in Commercial Distribution

  • 04250892902777 ()
176400

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176420-03
Not in Commercial Distribution

  • 04250892902760 ()
V-176420-03

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176400-03
Not in Commercial Distribution

  • 04250892902746 ()
V-176400-03

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176420-13
Not in Commercial Distribution

  • 04250892900513 ()
V-176420-13

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
176450-13
Not in Commercial Distribution

  • 04250892900476 ()
176450-13

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176420
Not in Commercial Distribution

  • 04250892900469 ()
V-176420

  • Pulmonary function analysis system, adult
MasterScreen IOS
Jaeger Medical GmbH
V-176420-03
Not in Commercial Distribution

  • 04250892900445 ()
V-176420-03

  • Pulmonary function analysis system, adult
G6 iOS
Dexcom, Inc.
SW11677
In Commercial Distribution

  • 00386270000804 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
for iOS
COCHLEAR LIMITED
NSA-1 / v4
In Commercial Distribution

  • 09321502060486 ()
P1787372

  • Audiometric/hearing device software
for iOS
COCHLEAR LIMITED
6.0
In Commercial Distribution

  • 09321502065764 ()
P1861019

  • Audiometric/hearing device software
for iOS
COCHLEAR LIMITED
NSA-1 / v5
In Commercial Distribution

  • 09321502062206 ()
P1834114

  • Audiometric/hearing device software
iOS App
INTRICON CORPORATION
HHE Hearing
In Commercial Distribution

  • 00858177007113 ()
23150

  • Audiometric/hearing device software
myAir (iOS)
RESMED CORP.
22245
In Commercial Distribution

  • 00840193400115 ()
22245

  • Self-care monitoring/reporting software
RMDpulse (iOS)
RESMED CORP.
22253
In Commercial Distribution

  • 00840193400030 ()


  • Ventilator application software
No Description
AUGMEDICS LTD
AMCH00030
In Commercial Distribution

  • 07290113780514 ()


  • Multi-purpose stereotactic surgery system
No Description
TYMPA HEALTH TECHNOLOGIES LIMITED
iOS
In Commercial Distribution

  • 25060753520070 ()


  • Video otoscope/audiometer
Axon Neurofeedback software Application for iOS
EXSURGO LIMITED
iOS
In Commercial Distribution

  • 09413000107500 ()
100318

  • Psychophysiological biofeedback system
Clue is a digital smartphone application helping people with cycles better understand their menstrual and reproductive health. There are three different modes for users to pick from, depending on what suits their current goal best Clue Period Tracking, Clue Conceive, and Clue Pregnancy. Across all modes there are different features that allow users to track their health experiences, access current scientific literature, and learn more about what’s happening to their body. Both a free version and a paid premium version of the app, called Clue Plus, are available to users. Clue Conceive is a mode of the Clue app. Clue Conceive's proprietary algorithm uses period start date information entered by the user to provide predictions on the best days to try and conceive.
BioWink GmbH
iOS
In Commercial Distribution

  • 04260749840039 ()


  • Self-care monitoring/reporting software
Clue Conceive is a mode of the Clue app. Clue Conceive's proprietary algorithm uses period start date information entered by the user to provide predictions on the best days to try and conceive. Identification of high chance days allows the user to determine the days on which their chance of conception is highest, and then make choices about when to have sex to increase chance of pregnancy.
BioWink GmbH
iOS
In Commercial Distribution

  • 04260749840015 ()


  • Self-care monitoring/reporting software
Eloquence iOS App
PRENTKE ROMICH COMPANY
Eloquence App
In Commercial Distribution

  • 00816486021237 ()
19683

  • Voice synthesizer/digitizer
DreamMapper App iOS
Respironics, Inc.
DreamMapper iOS, North American Instance - 2
In Commercial Distribution

  • 00606959057692 ()
1101478

  • Self-care monitoring/reporting software
G7 iOS App
Dexcom, Inc.
SW12300
In Commercial Distribution

  • 00386270001863 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
DreamMapper Application iOS
Respironics, Inc.
2.6
In Commercial Distribution

  • 00606959044340 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper Application iOS
Respironics, Inc.
2.5
In Commercial Distribution

  • 00606959041943 ()
1101478

  • Self-care monitoring/reporting software
Mobile application (iOS)
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
43307
In Commercial Distribution

  • 09008737433079 ()


  • Audiometric/hearing device software
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