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 Silaris™ Influenza A&B Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris™ Influenza A&B Test.
MESA BIOTECH, INC.
1024
In Commercial Distribution

  • B54010240 ()
1024

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
Q Station™ Dx 1000
QUARK BIOSCIENCES TAIWAN, INC. (HSINCHU PLANT)
Q Station
In Commercial Distribution

  • 04719890680020 ()
QST-Dx1000-2

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Q Station™ Dx 1000
QUARK BIOSCIENCES TAIWAN, INC. (HSINCHU PLANT)
Q Station
In Commercial Distribution

  • 04719890680013 ()
QST-Dx1000-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
The GenXplore® system is an automated qPCR-based nucleic acid testing system. It can perform nucleic acid extraction, liquid handling, thermal cycling, and real-time fluorescence detection for testing nucleic acids from human samples, specifically for in vitro diagnostic purposes. The GenXplore® system is intended for professional use only and indoor use only.
CHROMA ATE INC.
GenXplore q4800
In Commercial Distribution

  • 04719889100102 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFEOS GENOMICS CORPORATION
md1000 Dx
In Commercial Distribution

  • 04719880531103 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Xiamen Weiyou Intelligent Technology Co.,Ltd
CX5
In Commercial Distribution

  • 06971234470447 ()


  • Circulating-fluid localized thermal therapy system
HotRock is a self-heated foam roller used to relieve minor ache and pains. It is basically a heating pad built into a foam roller.
MEDROCK, INC
HR-001
In Commercial Distribution

  • 00860000412711 ()


  • External manual massager, clinical
Pain Relief, Multi-function Physiotherapy table, thermal infrared therapeutic heating, Therapeutic manual and electric massage, muscle relaxation, increase circulation.
MIGUN LIFE CO., LTD
HY7000UM
In Commercial Distribution

  • B556HY7000UM0 ()


  • Freestanding electric massager
  • Musculoskeletal infrared phototherapy unit, non-wearable
  • Traction table, line-powered
Low level Light System (red light LED and infrared LED) that applies 635nm light and 880nm light for Aesthtic use and for pain indications.
KBL GmbH
R11-s-2848r1-1188i1 UP 12
In Commercial Distribution

  • 04260489020425 ()


  • Red/infrared light phototherapy unit
No Description
Azure Biosystems Inc.
Azure Cielo 6 Dx
In Commercial Distribution

  • 00860006465612 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
No Description
Azure Biosystems Inc.
Azure Cielo 3 Dx
In Commercial Distribution

  • 00860006465605 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
No Description
Estill Medical Technologies, Inc.
TA-UPC
In Commercial Distribution

  • 00861816000390 ()
  • 00861816000345 ()
  • 10861816000342 ()


  • Convection blood/fluid warmer
The TA-UB1 Thermal Angel Ultra Battery is a rechargeable 12V LifePO4 (LFP) battery designed to power the Thermal Angel TA-200.
Estill Medical Technologies, Inc.
TA-UB1
In Commercial Distribution

  • 00861816000338 ()
  • 00861816000352 ()


  • Convection blood/fluid warmer
A blood warmer and IV fluid warmer, the Thermal Angel is a battery-powered disposable, lightweight easy to use portable blood and IV fluid warming device. The Thermal Angel blood warmer works in your environmen
Estill Medical Technologies, Inc.
TA-200
In Commercial Distribution

  • 00861816000314 ()
  • 00861816000307 ()
  • 00861816000321 ()


  • Convection blood/fluid warmer
A combination kit consisting 1 Water Path Kit and 1 Sonablate Probe Tip Kit
FOCUS SURGERY INC
403-02200-0014
In Commercial Distribution

  • 00868108000267 ()


  • Ultrasonic hyperthermia system
Sonasource is comprised of several integrated programmable hardware and software modules that are used to drive and control SonaCare Medical's probes. The console includes all electronics required for user interaction with all probe imaging and treatment functions.
FOCUS SURGERY INC
102-17000-0009
In Commercial Distribution

  • 00868108000212 ()


  • Ultrasonic hyperthermia system
System used to regulate temperature and oxygen content of sterile water for a procedure.
FOCUS SURGERY INC
102-17000-0007
In Commercial Distribution

  • 00868108000274 ()


  • Ultrasonic hyperthermia system
Sonablate Probe HF 30/40 3G is an image-guided device that allows physicians to ablate tissue using ultrasound energy.
FOCUS SURGERY INC
202-17000-0012
In Commercial Distribution

  • 00868108000229 ()


  • Ultrasonic hyperthermia system
No Description
ICU MEDICAL, INC.
100/199/085
In Commercial Distribution

  • 35019315022351 ()
  • 15019315022357 ()
  • 55019315022355 ()


  • Infant resuscitation cabinet
No Description
BELMONT INSTRUMENT CORPORATION
902-00048
In Commercial Distribution

  • 10896128002579 ()


  • Extravascular-circulation hyperthermia system applicator, intracorporeal
No Description
BELMONT INSTRUMENT CORPORATION
902-00043
Not in Commercial Distribution

  • 10896128002296 ()


  • Extravascular-circulation hyperthermia system applicator, intracorporeal
No Description
BELMONT INSTRUMENT CORPORATION
902-00036
In Commercial Distribution

  • 10896128002289 ()


  • Extravascular-circulation hyperthermia system applicator, intracorporeal
No Description
BELMONT INSTRUMENT CORPORATION
902-00004
Not in Commercial Distribution

  • 10896128002265 ()


  • Extravascular-circulation hyperthermia system applicator, intracorporeal
The AMSCO Pass-Thru OR Consolidated Warming Cabinet with 120V, 24-inch wide, dual compartment, solid doors, 18-inch depth, Standard Control is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable Level.
STERIS CORPORATION
CB4721003001
In Commercial Distribution

  • 00724995154189 ()
CB4721003001

  • Multi-purpose warming cabinet, recessed
The AMSCO Glass Door Mid-Size Compartment Premium Cabinet, Mobile Base with Electronic Door Locks and Electronic Data Recording, 120V, is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable Level.
STERIS CORPORATION
DJ06012412313
In Commercial Distribution

  • 00724995154004 ()
DJ06012412313

  • Multi-purpose warming cabinet, mobile
The AMSCO Warming Cabinet Premium Solid Dual 24-inch 120V Mobile Electronic Door Locks Electronic Data Recording is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable Level.
STERIS CORPORATION
DJ04012433113
In Commercial Distribution

  • 00724995154134 ()
DJ04012433113

  • Multi-purpose warming cabinet, mobile
The AMSCO Warming Cabinet Standard Glass Dual 24-inch 120V Mobile, is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable Level.
STERIS CORPORATION
DJ06012433111
In Commercial Distribution

  • 00724995154042 ()
DJ06012433111

  • Multi-purpose warming cabinet, mobile
The AMSCO Warming Cabinet Premium Glass Dual 24-inch 120V Mobile Electronic Door Locks Electronic Data Recording is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable Level.
STERIS CORPORATION
DJ06012433113
In Commercial Distribution

  • 00724995154028 ()
DJ06012433113

  • Multi-purpose warming cabinet, mobile
The AMSCO Warming Cabinet Standard Solid Dual 24-inch 120V Mobile is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable Level.
STERIS CORPORATION
DJ04012433111
In Commercial Distribution

  • 00724995153960 ()
DJ04012433111

  • Multi-purpose warming cabinet, mobile
Warming Cabinet Standard Glass Dual 24-inch Mobile is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable level.
STERIS CORPORATION
Warming Cabinet
In Commercial Distribution

  • 00724995153816 ()
DJ06014433111

  • Multi-purpose warming cabinet, mobile
6th Generation Mid-size Single Compartment Mobile Warming Cabinet is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable level.
STERIS CORPORATION
Warming Cabinet
In Commercial Distribution

  • 00724995153779 ()
DJ06014412313

  • Multi-purpose warming cabinet, mobile
JBAIDS Instrument
BIOFIRE DEFENSE, LLC
JB01
Not in Commercial Distribution

  • 00851458005006 ()
JRPD-ASY-0001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
LAPAROSCOPIC VESSEL HARVESTING GAS CONDITIONING DEVICE
LEXION MEDICAL, LLC
1117
In Commercial Distribution

  • 00852588007076 ()
1117

  • Insufflation gas conditioning tubing set
LAPAROSCOPIC GAS CONDITIONING DEVICE
LEXION MEDICAL, LLC
6198M
Not in Commercial Distribution

  • 00852588007038 ()
6198M

  • Insufflation gas conditioning tubing set
LAPAROSCOPIC GAS CONDITIONING DEVICE
LEXION MEDICAL, LLC
PP1000NS
Not in Commercial Distribution

  • 00852588007021 ()
PP1000NS

  • Insufflation gas conditioning tubing set
Laparoscopic gas conditioning device
LEXION MEDICAL, LLC
6198NS
Not in Commercial Distribution

  • 00852588007014 ()
6198NS

  • Insufflation gas conditioning tubing set
Laparoscopic gas conditioning device.
LEXION MEDICAL, LLC
6198
In Commercial Distribution

  • 00852588007007 ()
6198

  • Insufflation gas conditioning tubing set
HUMIDIFIED INSUFFLATION KIT
FISHER & PAYKEL HEALTHCARE LIMITED
ST520
In Commercial Distribution

  • 09420012433985 ()
  • 09420012433978 ()
ST520

  • Insufflation gas conditioning tubing set
HUMIDIFIER SH870 115V US
FISHER & PAYKEL HEALTHCARE LIMITED
SH870JHU
In Commercial Distribution

  • 09420012433060 ()
SH870JHU

  • Insufflation gas conditioning system control unit
No Description
Merchsource, LLC
1017475
In Commercial Distribution

  • 00843479186611 ()


  • Foot bath
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