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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Smart Spirometer connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
mSpirometer
In Commercial Distribution

  • 08052990321636 ()


  • Expiratory peak flow meter, digital
Smart Spirometer connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
MIR SPIROBANK SMART
In Commercial Distribution

  • 08052990321124 ()
911105

  • Expiratory peak flow meter, digital
Air Innovations Top Fill Bluetooth Speaker with APP & Extension Nozzle - Black
GREAT INNOVATIONS, LLC
MH-906
In Commercial Distribution

  • 00180104000813 ()


  • Room humidifier
Air Innovations Top Fill Bluetooth Speaker with APP & Extension Nozzle - White
GREAT INNOVATIONS, LLC
MH-906
In Commercial Distribution

  • 00180104000806 ()


  • Room humidifier
Air Innovations Top Fill Bluetooth Speaker with APP & Extension Nozzle - Navy
GREAT INNOVATIONS, LLC
MH-906
In Commercial Distribution

  • 00180104000790 ()


  • Room humidifier
Air Innovations Top Fill Bluetooth Speaker with APP & Extension Nozzle - Red
GREAT INNOVATIONS, LLC
MH-906
In Commercial Distribution

  • 00180104000783 ()


  • Room humidifier
DRSHD 1080p System, Rev 7https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Nds Surgical Imaging LLC
DRSHD.7
Not in Commercial Distribution

  • 00817613020000 ()


  • Endoscopic video image processing unit
HD Rapid Simplified / 07 150grhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Vertex-Dental B.V.
HDARSP0700150
Not in Commercial Distribution

  • 08719425505121 ()


  • Dental appliance fabrication material, resin
Hoen Nerve Hook Straight 22cmhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
KOROS U.S.A., INC.
7225-05
In Commercial Distribution

  • 00840199507528 ()
  • 10840199507525 ()

  • 9x12mm
7225-05

  • Soft-tissue surgical hook, reusable
GAS-ASSISTED SPRAY SET ENDOSCOPIC APP. 5MM 30 CM, 1:1 RATIO
Micromedics, Inc.
SA-3654
In Commercial Distribution

  • 10815634020075 ()
  • 00815634020078 ()
  • 20815634020072 ()


  • Open-surgery adhesive/sealant applicator, dual-channel
6mm Kerrison Rongeur, 350mm https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Osseus Fusion Systems, LLC
1760-7070
In Commercial Distribution

  • B06217607070 ()
1760-7070

  • Spinal rongeur
Gastric Bypass Pack _Sterile_3EA/CShttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
GRI Medical & Electronic Technology Co., Ltd.
LGH011
In Commercial Distribution

  • 26931918174539 ()
  • 16931918174532 ()


  • General surgical procedure kit, non-medicated, single-use
No Description
Zhejiang Shuyou Surgical Instrument Co.,Ltd.
VIX-A015腔镜电极
In Commercial Distribution

  • 06924274950608 ()


  • Open-surgery electrosurgical electrode, monopolar, single-use
M300 OvuCore Starter Pack - M026 OvuCore Vaginal Sensor and M032 OvuSense App
VIO HEALTHTECH LIMITED
M300
In Commercial Distribution

  • 05060508530039 ()


  • Thermometric fertility analyser
Pressure PreventionGroup 1 Surfaces Product Description: APP Pad Only, 1/ea, RTL
Drive Devilbiss Healthcare
14003
In Commercial Distribution

  • 50822383103742 ()
  • 00822383103747 ()


  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure bed mattress overlay system
Ear thermometer with bluetooth which transmits data to app on mobile phone
Masena Invest B.V.
ET-624BT
In Commercial Distribution

  • 08719481720193 ()


  • Intermittent electronic patient thermometer
Robot Arm Interface instrument Rosa 3.0 instrument ROSA One spine app 3.1
MEDTECH
ROSA3-048A
Not in Commercial Distribution

  • 03760244030436 ()
ROSAS00126

  • Neurological stereotactic surgery system
  • Multi-purpose stereotactic surgery system
RIGID ENDOSCOPIC AEROSOL APP. 5MM DIA X 40CM (16 IN) 1:1
Micromedics, Inc.
800-0217
In Commercial Distribution

  • 00815634020283 ()
  • 10815634020280 ()
  • 20815634020287 ()


  • Open-surgery adhesive/sealant applicator, dual-channel
The ZEISS® Connect App mobile application will be an optional accessory of ZEISS® UNO 3 microscope product. ZEISS® Connect application SW will be available to the end user as an iOS app and user should be able to download and install the same from Apple App store. ZEISS® Connect App will pair wirelessly to the UNO3 variants of microscope and associated peripheral devices (like monitor etc.). This database entry covers UDI for SW version 2.0 and higher. Version 2.0-> UDI - (01)04049539070135(10)200-> Version 3.0-> UDI - (01)04049539070135(10)301 ->Version 4.2-> UDI - (01)04049539070135(10)420
Carl Zeiss Meditec AG
2.0
In Commercial Distribution

  • 04049539070135 ()


  • Multidisciplinary medical image management software
Curing Light
Guilin Woodpecker Medical Instrument Co., Ltd.
LUX E简约版
In Commercial Distribution

  • 06944843602189 ()


  • Dental/surgical polymerization lamp
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