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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TULSA-PRO® MAGNET KIT – SIEMENS BED 515.7mm PITCH (SOLA)
Profound Medical Inc
109312
In Commercial Distribution

  • 07540281001288 ()


  • Therapeutic oncological/gynaecological ultrasound system
TULSA-PRO® MAGNET KIT – SIEMENS BED 511.5mm PITCH
Profound Medical Inc
108053
In Commercial Distribution

  • 07540281001240 ()


  • Therapeutic oncological/gynaecological ultrasound system
TULSA-PRO® MAGNET KIT – SIEMENS BED 518.5mm PITCH
Profound Medical Inc
107861
In Commercial Distribution

  • 07540281001233 ()


  • Therapeutic oncological/gynaecological ultrasound system
TULSA-PRO® MAGNET KIT – SKYRA
Profound Medical Inc
104843
In Commercial Distribution

  • 07540281001196 ()


  • Therapeutic oncological/gynaecological ultrasound system
Cable - UA to PSIB 3T Siemens
Profound Medical Inc
106955
In Commercial Distribution

  • 07540281000922 ()


  • Therapeutic oncological/gynaecological ultrasound system
Cable – UA to PSIB, 1.5T Siemens
Profound Medical Inc
107189
In Commercial Distribution

  • 07540281000915 ()


  • Therapeutic oncological/gynaecological ultrasound system
Cable- UA to PSIB 1.5T Philips 63.87 MHZ
Profound Medical Inc
106647
In Commercial Distribution

  • 07540281000908 ()


  • Therapeutic oncological/gynaecological ultrasound system
Cable – PS to PSIB,1.5T
Profound Medical Inc
106583
In Commercial Distribution

  • 07540281000892 ()


  • Therapeutic oncological/gynaecological ultrasound system
CABLE – PS to PSIB, 3.0T
Profound Medical Inc
106582
In Commercial Distribution

  • 07540281000885 ()


  • Therapeutic oncological/gynaecological ultrasound system
Cable - FB to PSIB, 40 FT
Profound Medical Inc
106475
In Commercial Distribution

  • 07540281000878 ()


  • Therapeutic oncological/gynaecological ultrasound system
Cable - UA to PSIB, 3T Philips
Profound Medical Inc
106708
In Commercial Distribution

  • 07540281000861 ()


  • Therapeutic oncological/gynaecological ultrasound system
TULSA-PRO® MAGNET KIT – INGENUITY
Profound Medical Inc
106095
In Commercial Distribution

  • 07540281000847 ()


  • Therapeutic oncological/gynaecological ultrasound system
TULSA-PRO® MAGNET KIT – INGENIA
Profound Medical Inc
105392
In Commercial Distribution

  • 07540281000830 ()


  • Therapeutic oncological/gynaecological ultrasound system
TULSA-PRO® MAGNET KIT – PRISMA
Profound Medical Inc
105391
In Commercial Distribution

  • 07540281000823 ()


  • Therapeutic oncological/gynaecological ultrasound system
TULSA-PRO® MAGNET KIT – ACHIEVA
Profound Medical Inc
104969
In Commercial Distribution

  • 07540281000816 ()


  • Therapeutic oncological/gynaecological ultrasound system
TULSA-PRO Disposable Kit
Profound Medical Inc
104558
In Commercial Distribution

  • 07540281000212 ()


  • Therapeutic oncological/gynaecological ultrasound system
TULSA-PRO Tube-set - Endorectal Cooling Device
Profound Medical Inc
104011
In Commercial Distribution

  • 07540281000182 ()


  • Therapeutic oncological/gynaecological ultrasound system
TULSA-PRO Tube-set Ultrasound Applicator
Profound Medical Inc
104010
In Commercial Distribution

  • 07540281000175 ()


  • Therapeutic oncological/gynaecological ultrasound system
TULSA-PRO Endorectal Cooling Device
Profound Medical Inc
104009
In Commercial Distribution

  • 07540281000168 ()


  • Therapeutic oncological/gynaecological ultrasound system
TULSA-PRO Ultrasound Applicator
Profound Medical Inc
104008
In Commercial Distribution

  • 07540281000151 ()


  • Therapeutic oncological/gynaecological ultrasound system
TULSA-PRO Positioning System Interface Box
Profound Medical Inc
106515
In Commercial Distribution

  • 07540281000144 ()


  • Therapeutic oncological/gynaecological ultrasound system
TULSA-PRO Filter Box
Profound Medical Inc
106604
In Commercial Distribution

  • 07540281000137 ()


  • Therapeutic oncological/gynaecological ultrasound system
TULSA-PRO Positioning System
Profound Medical Inc
106585
In Commercial Distribution

  • 07540281000120 ()


  • Therapeutic oncological/gynaecological ultrasound system
Cable - UA to PSIB, 128MHz
Profound Medical Inc
105486
In Commercial Distribution

  • 07540281000113 ()


  • Therapeutic oncological/gynaecological ultrasound system
Cable - UA to PSIB, 123MHz
Profound Medical Inc
105485
In Commercial Distribution

  • 07540281000106 ()


  • Therapeutic oncological/gynaecological ultrasound system
Cable - FB to PSIB, 40 FT
Profound Medical Inc
103708
In Commercial Distribution

  • 07540281000090 ()


  • Therapeutic oncological/gynaecological ultrasound system
Cable - SE to FB, 25FT
Profound Medical Inc
103705
In Commercial Distribution

  • 07540281000083 ()


  • Therapeutic oncological/gynaecological ultrasound system
TULSA-PRO Treatment Delivery Console
Profound Medical Inc
104495
In Commercial Distribution

  • 07540281000076 ()


  • Therapeutic oncological/gynaecological ultrasound system
TULSA-PRO Positioning System Interface Box
Profound Medical Inc
104494
In Commercial Distribution

  • 07540281000069 ()


  • Therapeutic oncological/gynaecological ultrasound system
TULSA-PRO Filter Box
Profound Medical Inc
104493
In Commercial Distribution

  • 07540281000052 ()


  • Therapeutic oncological/gynaecological ultrasound system
TULSA-PRO System Cart
Profound Medical Inc
104492
In Commercial Distribution

  • 07540281000045 ()


  • Therapeutic oncological/gynaecological ultrasound system
TULSA-PRO Positioning System
Profound Medical Inc
104491
In Commercial Distribution

  • 07540281000038 ()


  • Therapeutic oncological/gynaecological ultrasound system
TULSA-PRO System Electronics
Profound Medical Inc
104470
In Commercial Distribution

  • 07540281000021 ()


  • Therapeutic oncological/gynaecological ultrasound system
TULSA-PRO System
Profound Medical Inc
PAD-105
In Commercial Distribution

  • 07540281000014 ()


  • Therapeutic oncological/gynaecological ultrasound system
Catheter Cable
BOSTON SCIENTIFIC CORPORATION
M004RARC040
In Commercial Distribution

  • 00191506020408 ()

  • Length: 200 Centimeter
M004RARC040

  • Electrical-only medical device connection cable, reusable
Sensor Enabled Ablation Connection Cable 8.2ft 20 Green/10 White/14 Yellow Pins
INNOVATIVE HEALTH LLC
N/A
In Commercial Distribution

  • 10841898130274 ()
A-FASE-CBL4

  • Electrical-only medical device connection cable, reprocessed
RF PROBE ABLATION SCULPTOR-S 60 DEGREE W/INTEGRATED CABLE WITH SUCTION BLACK SHAFT
STERILMED, INC.
SMI7210696
Not in Commercial Distribution

  • 10888551034548 ()
SMI7210696

  • Endoscopic electrosurgical electrode, monopolar, single-use
RF PROBE ABLATION SAPHYRE II BIPOLAR 90° W/INTEGRATED CABLE & SUCTION GRAY SHAFT
STERILMED, INC.
SMI7210111
Not in Commercial Distribution

  • 10888551034517 ()
SMI7210111

  • Endoscopic electrosurgical electrode, bipolar, reprocessed
RF PROBE ABLATION SCULPTOR-S 90 DEG W/INTEGRATED CABLE WITH SUCTION BLACK SHAFT
STERILMED, INC.
SMI7210697
Not in Commercial Distribution

  • 10888551034555 ()
SMI7210697

  • Endoscopic electrosurgical electrode, monopolar, single-use
RF applicator intended for dermatological procedures requiring ablation and resurfacing of the skin.
VENUS CONCEPT LTD
AS120070
In Commercial Distribution

  • 07290016540482 ()
  • 07290016540604 ()


  • Radio-frequency skin contouring system applicator, bipolar
Field generator clamp assembly that connects the Planar Field generator to the hospital bed
ACESSA HEALTH INC.
MS-05-0257
In Commercial Distribution

  • 00854763006249 ()


  • Radio-frequency ablation system
  • Electromagnetic surgical navigation device tracking system
Acessa ProVu Planar Field Generator (PFG), connects to the ProVu Console
ACESSA HEALTH INC.
8100
In Commercial Distribution

  • 00854763006195 ()


  • Radio-frequency ablation system
  • Electromagnetic surgical navigation device tracking system
MTR 2.0 Main Unit
ILOODA.CO.,LTD
MTR 2.0 Main Unit
In Commercial Distribution

  • 08800023200171 ()


  • Radio-frequency skin surface treatment system
  • Electrosurgical system
No Description
CLASSYS Inc.
MOR-C1
In Commercial Distribution

  • 08800016904765 ()


  • Electrosurgical system
  • Intradermal radio-frequency ablation system
No Description
CLASSYS Inc.
MOR-C1
In Commercial Distribution

  • 08800016904758 ()


  • Electrosurgical system
  • Intradermal radio-frequency ablation system
No Description
CLASSYS Inc.
MOR-C1
In Commercial Distribution



  • Electrosurgical system
  • Intradermal radio-frequency ablation system
HALYARD* Multi-COOLED RF Kit
Avanos Medical, Inc.
40608
In Commercial Distribution

  • 10680651406085 ()
MCK2-17-75-4

  • Neurosurgical procedure kit, non-medicated, single-use
  • Radio-frequency ablation system
HALYARD* Multi-COOLED RF Kit
Avanos Medical, Inc.
40589
In Commercial Distribution

  • 10680651405897 ()
MCK3-17-75-4

  • Neurosurgical procedure kit, non-medicated, single-use
  • Radio-frequency ablation system
Cable for neutral electrode
OLYMPUS Winter & Ibe GmbH
WA99510A
In Commercial Distribution

  • 04042761085892 ()
WA99510A

  • Electrosurgical return lead
REUSABLE CABLE, SPLIT PAD, 15 FT
MEDLINE INDUSTRIES, INC.
PAD21174L
In Commercial Distribution

  • 10193489082456 ()
PAD21174L

  • Electrosurgical return lead
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