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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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Eversense Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-02-300
In Commercial Distribution

  • 00817491023520 ()
FG-5501-02-300

  • Implantable glucose monitoring system
No Description
Thought Technology Ltd.
SA4520
In Commercial Distribution

  • 07540191000623 ()


  • Psychophysiological biofeedback system
Babysat System Application.
Owlet Baby Care, Inc.
2.23.0
In Commercial Distribution

  • 00810099090079 ()


  • Multiple vital physiological parameter monitoring system, home-use
For Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622929-120
Not in Commercial Distribution

  • 00802526623110 ()
2929

  • Implantable cardiac device management application software
for Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622939-120
Not in Commercial Distribution

  • 00802526623103 ()
2939

  • Implantable cardiac device management application software
for Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
2939
In Commercial Distribution

  • 00802526618215 ()
2939

  • Implantable cardiac device management application software
For Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
2929
In Commercial Distribution

  • 00802526618208 ()
2929

  • Implantable cardiac device management application software
for Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
622925-100
In Commercial Distribution

  • 00802526607608 ()
622925-100

  • Implantable cardiac device management application software
Omnipod 5 Controller APP iOS V1.x
Insulet Corporation
M009-S-AP
In Commercial Distribution

  • 10385083000336 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Controller APP iOS V2.x
Insulet Corporation
M009-2S-AP
In Commercial Distribution

  • 10385083000459 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
WOLF ILLUM TO PILLING CABLE ADAPTER
TELEFLEX INCORPORATED
IPN007858
In Commercial Distribution

  • 14026704658418 ()
50615AC

  • Fibreoptic light cable
ACMI ILLUM TO PILLING CABLE ADAPTER
TELEFLEX INCORPORATED
IPN007853
In Commercial Distribution

  • 14026704658401 ()
50614AC

  • Fibreoptic light cable
Mariner MIS Screw to Screw Distractor
Seaspine Orthopedics Corporation
SR-0493
In Commercial Distribution

  • 10889981220891 ()
SR-0493

  • Orthopaedic surgical distractor, internal
DC TO DC POWER ADAPTER,LP15
PHYSIO-CONTROL, INC.
11140
In Commercial Distribution

  • 00883873940112 ()
11140-000074

  • Basic power supply, reusable
Connector, 15mm O.D to 15mm O.D
WESTMED, INC.
S6261
Not in Commercial Distribution

  • 10709078012546 ()
  • 00709078012532 ()


  • Straight/elbow breathing circuit connector, single-use
Instrument, Handpiece to Wrench Converter, Universal
SOUTHERN IMPLANTS (PTY) LTD
I-WI-H
In Commercial Distribution

  • 06009544014935 ()


  • Dental implant/prosthesis surgical procedure kit
Instrument, Handpiece to Wrench Converter, Short
SOUTHERN IMPLANTS (PTY) LTD
I-WI-C-S
In Commercial Distribution

  • 06009544014850 ()


  • Surgical torque wrench adaptor
Instrument, Handpiece to Wrench Converter, Long
SOUTHERN IMPLANTS (PTY) LTD
I-WI-C-L
In Commercial Distribution

  • 06009544014836 ()


  • Surgical torque wrench adaptor
Instrument, Connector to Handpiece, Universal, Short
SOUTHERN IMPLANTS (PTY) LTD
I-CONU-XS
In Commercial Distribution

  • 06009544010579 ()


  • Dental implant holding endpiece, reusable
Dual Yoke to LCH Conversion Kit
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007336 ()
SL-30M-YK-LCH-RPL-KIT

  • Operating room light
intended to measure human body temperature
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,LTD.
DT-K111I
In Commercial Distribution

  • 06931562702719 ()


  • Infrared patient thermometer, skin
intended to measure human body temperature
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,LTD.
DT-Y111D
In Commercial Distribution

  • 06931562701972 ()


  • Intermittent electronic patient thermometer
intended to measure human body temperature
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,LTD.
DT-111D
In Commercial Distribution

  • 06931562701668 ()


  • Intermittent electronic patient thermometer
intended to measure human body temperature
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,LTD.
DT-01D
In Commercial Distribution

  • 06931562701477 ()


  • Infrared patient thermometer, skin
intended to measure human body temperature
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,LTD.
DT-01D
In Commercial Distribution

  • 06931562701439 ()


  • Intermittent electronic patient thermometer
intended to measure human body temperature
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,LTD.
FT-100D
In Commercial Distribution

  • 06931562700883 ()


  • Infrared patient thermometer, skin
intended to measure human body temperature
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,LTD.
T104
In Commercial Distribution

  • 06931562700746 ()


  • Intermittent electronic patient thermometer
intended to measure human body temperature
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,LTD.
T516
In Commercial Distribution

  • 06931562700739 ()


  • Intermittent electronic patient thermometer
intended to measure human body temperature
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,LTD.
T104
In Commercial Distribution

  • 06931562700722 ()


  • Intermittent electronic patient thermometer
intended to measure human body temperature
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,LTD.
DT-K111J
In Commercial Distribution

  • 06931562702726 ()


  • Infrared patient thermometer, skin
intended to measure human body temperature
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,LTD.
DT-101B
In Commercial Distribution

  • 06931562701989 ()


  • Intermittent electronic patient thermometer
intended to measure human body temperature
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,LTD.
DT-111B
In Commercial Distribution

  • 06931562701712 ()


  • Intermittent electronic patient thermometer
intended to measure human body temperature
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,LTD.
DT-01D
In Commercial Distribution

  • 06931562701637 ()


  • Infrared patient thermometer, skin
intended to measure human body temperature
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,LTD.
DT-101B
In Commercial Distribution

  • 06931562701446 ()


  • Intermittent electronic patient thermometer
intended to measure human body temperature
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,LTD.
T516
In Commercial Distribution

  • 06931562700807 ()


  • Intermittent electronic patient thermometer
intended to measure human body temperature
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,LTD.
T208
In Commercial Distribution

  • 06931562700791 ()


  • Intermittent electronic patient thermometer
Parallel Top Loading to 5.5/6.0mm
Seaspine Orthopedics Corporation
PC1-023560
In Commercial Distribution

  • 10889981196769 ()
PC1-023560

  • Bone-screw internal spinal fixation system connector
CHUCK - Q-SERIES TO ZIMMER/HUDSON OUTPUT
DE SOUTTER MEDICAL LIMITED
15470
In Commercial Distribution

  • 05051471119598 ()
15470

  • Surgical drill chuck
ADAPTOR MA7 MALE TO AO FEMALE
DE SOUTTER MEDICAL LIMITED
12400
In Commercial Distribution

  • 05051471085084 ()
12400

  • Pneumatic surgical power tool hose
CHUCK ADAPTOR - JACOBS TO TRINKLE OUTPUT
DE SOUTTER MEDICAL LIMITED
10240
In Commercial Distribution

  • 05051471044982 ()
10240

  • Surgical drill chuck
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