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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OASIS NXT 2017.2 COSTCO
Bernafon AG
186358
In Commercial Distribution

  • 05711584083215 ()


  • Audiometric/hearing device software
JU7 C, VC PS COBU /MSIL JUNA 7
Bernafon AG
184875
In Commercial Distribution

  • 05711584083031 ()


  • Air-conduction hearing aid, behind-the-ear
JU7 C, VC PS SABE /MSIL JUNA 7
Bernafon AG
184874
In Commercial Distribution

  • 05711584083024 ()


  • Air-conduction hearing aid, behind-the-ear
JU7 C, VC PS MAC /MSIL JUNA 7
Bernafon AG
184873
In Commercial Distribution

  • 05711584083017 ()


  • Air-conduction hearing aid, behind-the-ear
JU7 C, VC PS JEBL /MSIL JUNA 7
Bernafon AG
184872
In Commercial Distribution

  • 05711584083000 ()


  • Air-conduction hearing aid, behind-the-ear
JU7 C, VC PS COBR /MSIL JUNA 7
Bernafon AG
184871
In Commercial Distribution

  • 05711584082997 ()


  • Air-conduction hearing aid, behind-the-ear
JU7 C, VC PS MAC /MAC JUNA 7
Bernafon AG
184870
In Commercial Distribution

  • 05711584082980 ()


  • Air-conduction hearing aid, behind-the-ear
JU7 C, VC PS ANBR /MAC JUNA 7
Bernafon AG
184869
In Commercial Distribution

  • 05711584082973 ()


  • Air-conduction hearing aid, behind-the-ear
The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a solution of up to 1.0% cobalt chloride and up to 2.0% N-Acetyl cysteine, in a ratio of 1:2. Zirconium oxide is sealed within the device. The length of the polymer capsule is between 5.5 mm and 10.0 mm, and the diameter is 1.0 mm. It is loaded in an implant needle and sterilized with Ethylene Oxide.
C4 IMAGING, LLC
F-01-03-0111
In Commercial Distribution

  • 00863593000259 ()


  • Radiological image marker, implantable
JU7 C, VC PS SABE /MAC JUNA 7
Bernafon AG
184867
In Commercial Distribution

  • 05711584082959 ()


  • Air-conduction hearing aid, behind-the-ear
HEARTOO STUDIO
Bernafon AG
185294
In Commercial Distribution

  • 05711584082850 ()


  • Audiometric/hearing device software
The SIRIUS MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy sources containing one of the following isotopes: Iodine 125 (125I), Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy.
C4 IMAGING, LLC
F-01-01-0001
In Commercial Distribution

  • 00863593000211 ()
F-01-01-0001

  • Brachytherapy source spacer
The SIRIUS MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy sources containing one of the following isotopes: Iodine 125 (125I), Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy.
C4 IMAGING, LLC
C-01-99-0014
Not in Commercial Distribution

  • 00863593000204 ()
F-01-01-0001

  • Brachytherapy source spacer
AQ CO7 MNR, 2.4G NFM PB ANBR ACCUQ
Bernafon AG
181970
In Commercial Distribution

  • 05711584080337 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO7 MNR, 2.4G NFM PB COBR ACCUQ
Bernafon AG
181969
In Commercial Distribution

  • 05711584080320 ()


  • Air-conduction hearing aid, receiver-in-the-ear
MEDITECH's Blood Bank application tightly integrates donor, unit, and patient history information with data in the health care information system (HCIS). The application flags abnormal test results, reports test and transfusion results, minimizes product waste, utilizes expert rules when recording, and performs error checks. It also generates turnaround time and workload statistics, compiles statistical reports, and automatically captures charges. Authorized users have the ability to view blood bank results from within the network or remotely. All of these features ensure patient safety and reduce turnaround times.
MEDICAL INFORMATION TECHNOLOGY, INC.
Magic
In Commercial Distribution

  • 00863529000100 ()


  • Blood bank information system application software
AQ CO7 MNR, 2.4G NFM PB MAC ACCUQ
Bernafon AG
181967
In Commercial Distribution

  • 05711584080306 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO7 MNR, 2.4G NFM PB MAC/MSIL ACCUQ
Bernafon AG
181966
In Commercial Distribution

  • 05711584080290 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO7 MNR, 2.4G NFM PB MSIL/MAC ACCUQ
Bernafon AG
181964
In Commercial Distribution

  • 05711584080276 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO7 MNR, 2.4G NFM PB SABE/MSIL ACCUQ
Bernafon AG
181962
In Commercial Distribution

  • 05711584080252 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO7 MNR T, 2.4G NFM DPB MAC/MSIL ACCUQ
Bernafon AG
182151
In Commercial Distribution

  • 05711584079782 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO7 MNR T, 2.4G NFM DPB JEBL ACCUQ
Bernafon AG
182149
In Commercial Distribution

  • 05711584079768 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO7 MNR T, 2.4G NFM DPB COBR ACCUQ
Bernafon AG
182147
In Commercial Distribution

  • 05711584079744 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO7 MNR T, 2.4G NFM DPB ANBR ACCUQ
Bernafon AG
182146
In Commercial Distribution

  • 05711584079737 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO7 MNR T, 2.4G NFM DPB SABE/MSIL ACCUQ
Bernafon AG
182136
In Commercial Distribution

  • 05711584079720 ()


  • Air-conduction hearing aid, receiver-in-the-ear
The Compact is intended for breaking apart urinary tract stones, e.g., renal calyceal, renal pelvic, and ureteral stones. The purpose of the Shock Wave Generator is to convert the electric energy stored in a capacitor into mechanical energy. By generating high-energy sparks under water, shock waves are produced. The reflectors then focus these waves to converge at the common therapeutic focal point (F2).
DIREX SYSTEMS CORP.
COMPACT
In Commercial Distribution

  • 00863499000346 ()


  • Spark-gap lithotripsy system
AQ CO9 MNR, 2.4G NFM PB SABE/MAC ACCUQ
Bernafon AG
181961
In Commercial Distribution

  • 05711584079256 ()


  • Air-conduction hearing aid, receiver-in-the-ear
3Dscope is intended for acquisition, processing and display of fluoroscopy images. It can be also used together with an extra-corporeal shockwave lithotripsy. 3Dscope enables: • Visualization of various objects on fluoroscopy images (for example, kidney stones). • Generation and storage of patient records. • Comparing images obtained at different times. • Generation and management of patient data files and fluoroscopy images. The device is composed of the following units: • Workstation Console, which contains the application software for the system indicators and image display of the following:  System status  Fluoroscopy images • Gantry unit, which contains he HF X-Ray generator, image intensifier and digital camera. It performs the following:  Generator control  Image initial processing  Data transfer to the Workstation console.
DIREX SYSTEMS CORP.
3DSCOPE
In Commercial Distribution

  • 00863499000322 ()


  • Fluoroscopic x-ray system video image recording unit
AQ CO9 MNR, 2.4G NFM PB COBR ACCUQ
Bernafon AG
181959
In Commercial Distribution

  • 05711584079232 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO9 MNR, 2.4G NFM PB JEBL ACCUQ
Bernafon AG
181958
In Commercial Distribution

  • 05711584079225 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO9 MNR, 2.4G NFM PB MAC ACCUQ
Bernafon AG
181957
In Commercial Distribution

  • 05711584079218 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO9 MNR, 2.4G NFM PB MSIL/MAC ACCUQ
Bernafon AG
181954
In Commercial Distribution

  • 05711584079188 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO9 MNR, 2.4G NFM PB SABE/MSIL ACCUQ
Bernafon AG
181953
In Commercial Distribution

  • 05711584079171 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO9 MNR T, 2.4G NFM DPB ANBR ACCUQ
Bernafon AG
182145
In Commercial Distribution

  • 05711584078716 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO9 MNR T, 2.4G NFM DPB COBR ACCUQ
Bernafon AG
182144
In Commercial Distribution

  • 05711584078709 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO9 MNR T, 2.4G NFM DPB JEBL ACCUQ
Bernafon AG
182142
In Commercial Distribution

  • 05711584078686 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO9 MNR T, 2.4G NFM DPB MAC/MSIL ACCUQ
Bernafon AG
182140
In Commercial Distribution

  • 05711584078662 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO9 MNR T, 2.4G NFM DPB SABE/MSIL ACCUQ
Bernafon AG
182134
In Commercial Distribution

  • 05711584078648 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO7 MNR T, 2.4G NFM DPB SABE/MAC DEMO ACCUQ
Bernafon AG
182161
In Commercial Distribution

  • 05711584078174 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO9 MNR T, 2.4G NFM DPB SABE/MAC DEMO ACCUQ
Bernafon AG
182160
In Commercial Distribution

  • 05711584078167 ()


  • Air-conduction hearing aid, receiver-in-the-ear
AQ CO5 MNR, 2.4G NFM PB SABE/MAC DEMO ACCUQ
Bernafon AG
181982
In Commercial Distribution

  • 05711584078099 ()


  • Air-conduction hearing aid, receiver-in-the-ear
Body composition scale.
LEXINGTON WELLNESS HOLDINGS INC.
S-5
In Commercial Distribution

  • 10863398000277 ()
  • 00863398000270 ()
  • 20863398000274 ()


  • Bioelectrical body composition analyser
Body composition scale.
LEXINGTON WELLNESS HOLDINGS INC.
S-4
In Commercial Distribution

  • 10863398000260 ()
  • 00863398000263 ()


  • Bioelectrical body composition analyser
AQ CO5 B 105, 2.4G NFM DPB ANBR ACCUQ
Bernafon AG
182070
In Commercial Distribution

  • 05711584077825 ()


  • Air-conduction hearing aid, behind-the-ear
AQ CO5 B 105, 2.4G NFM DPB MAC/MSIL ACCUQ
Bernafon AG
182068
In Commercial Distribution

  • 05711584077801 ()


  • Air-conduction hearing aid, behind-the-ear
AQ CO5 B 105, 2.4G NFM DPB COBR ACCUQ
Bernafon AG
182066
In Commercial Distribution

  • 05711584077788 ()


  • Air-conduction hearing aid, behind-the-ear
AQ CO5 B 105, 2.4G NFM DPB SABE/MSIL ACCUQ
Bernafon AG
182064
In Commercial Distribution

  • 05711584077764 ()


  • Air-conduction hearing aid, behind-the-ear
AQ CO5 B 105, 2.4G NFM DPB MSIL/MAC ACCUQ
Bernafon AG
182062
In Commercial Distribution

  • 05711584077740 ()


  • Air-conduction hearing aid, behind-the-ear
ZR7 MNR T, 2.4G NFM DPB MAC ZERENA 7
Bernafon AG
176908
In Commercial Distribution

  • 05711584072882 ()


  • Air-conduction hearing aid, receiver-in-the-ear
ZR7 MNR T, 2.4G NFM DPB JEBL ZERENA 7
Bernafon AG
176907
In Commercial Distribution

  • 05711584072875 ()


  • Air-conduction hearing aid, receiver-in-the-ear
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