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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No Description
Stockert GmbH
20078
In Commercial Distribution

  • 04260166373233 ()
M004GEN100200780

  • Electrical-only medical device connection cable, reusable
No Description
Stockert GmbH
20075
In Commercial Distribution

  • 04260166373226 ()
M004GEN100200750

  • Electrical-only medical device connection cable, reusable
No Description
Stockert GmbH
20072
In Commercial Distribution

  • 04260166373219 ()
M004GEN100200720

  • Electrical-only medical device connection cable, reusable
No Description
Stockert GmbH
19951
In Commercial Distribution

  • 04260166373158 ()
M004GEN100199510

  • Electrical-only medical device connection cable, reusable
No Description
Stockert GmbH
19944
In Commercial Distribution

  • 04260166373127 ()
M004GEN100199440

  • Electrical-only medical device connection cable, reusable
No Description
Stockert GmbH
19948
In Commercial Distribution

  • 04260166373110 ()
M004GEN100199480

  • Electrical-only medical device connection cable, reusable
No Description
Stockert GmbH
19949
In Commercial Distribution

  • 04260166373103 ()
M004GEN100199490

  • Electrical-only medical device connection cable, reusable
No Description
Stockert GmbH
19947
In Commercial Distribution

  • 04260166373097 ()
M004GEN100199470

  • Electrical-only medical device connection cable, reusable
No Description
Stockert GmbH
20010
In Commercial Distribution

  • 04260166373066 ()
M004GEN100200100

  • Foot-switch, electrical
CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F
MEDTRONIC, INC.
239F3
Not in Commercial Distribution

  • 00613994804273 ()

  • Catheter tip length 8 mm
  • Length: 90.0 Centimeter
  • Catheter curve length 55 mm
  • Catheter shaft size 9 Fr


  • Cardiac cryosurgical system catheter
Generator Accessories
ST. JUDE MEDICAL, INC.
H700504
In Commercial Distribution

  • 05415067005045 ()
H700504

  • Electrical-only medical device connection cable, reusable
Footswitch
ST. JUDE MEDICAL, INC.
H700501
In Commercial Distribution

  • 05415067005014 ()

  • Length: 15 Meter
H700501

  • Foot-switch, electrical
Footswitch
ST. JUDE MEDICAL, INC.
H700500
In Commercial Distribution

  • 05415067005007 ()

  • Length: 10 Meter
H700500

  • Foot-switch, electrical
Footswitch
ST. JUDE MEDICAL, INC.
H700499
In Commercial Distribution

  • 05415067004994 ()

  • Length: 5 Meter
H700499

  • Foot-switch, electrical
Footswitch
ST. JUDE MEDICAL, INC.
H700498
In Commercial Distribution

  • 05415067004987 ()

  • Length: 2.5 Meter
H700498

  • Foot-switch, electrical
CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F
MEDTRONIC, INC.
239F3
Not in Commercial Distribution

  • 00643169023482 ()

  • Catheter shaft size 9 Fr
  • Catheter tip length 8 mm
  • Catheter shaft length 90 cm
  • Catheter curve size 55 mm


  • Cardiac cryosurgical system catheter
CATHETER 239F5 FREEZOR MAX5 LG ORANGE9F
MEDTRONIC, INC.
239F5
Not in Commercial Distribution

  • 00643169023475 ()

  • Catheter curve size 66 mm
  • Catheter shaft length 90 cm
  • Catheter shaft size 9 Fr
  • Catheter tip length 8 mm


  • Cardiac cryosurgical system catheter
CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F
MEDTRONIC, INC.
239F3
In Commercial Distribution

  • 00643169504905 ()

  • Catheter shaft size 9 Fr
  • Length: 90.0 Centimeter
  • Catheter tip length 8 mm
  • Catheter curve length 55 mm


  • Cardiac cryosurgical system catheter
CATHETER 239F5 FREEZOR MAX5 LG ORANGE9F
MEDTRONIC, INC.
239F5
In Commercial Distribution

  • 00643169504899 ()

  • Catheter shaft size 9 Fr
  • Catheter tip length 8 mm
  • Catheter curve length 66 mm
  • Length: 90.0 Centimeter


  • Cardiac cryosurgical system catheter
CATHETER 239F5 FREEZOR MAX5 LG ORANGE9F
MEDTRONIC, INC.
239F5
Not in Commercial Distribution

  • 00643169450387 ()

  • Shaft size 9 Fr
  • Curve length 66 mm
  • Length: 90.0 Centimeter
  • Tip length 8 mm


  • Cardiac cryosurgical system catheter
CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F
MEDTRONIC, INC.
239F3
Not in Commercial Distribution

  • 00643169450370 ()

  • Length: 90.0 Centimeter
  • Shaft size 9 Fr
  • Curve length 55 mm
  • Tip length 8 mm


  • Cardiac cryosurgical system catheter
Remote Control Panel Refurbished
BOSTON SCIENTIFIC CORPORATION
M00421880R0
Not in Commercial Distribution

  • 08714729790006 ()
M00421880R0

  • Percutaneous radio-frequency ablation system generator
Remote Control Cable
BOSTON SCIENTIFIC CORPORATION
M004SVGA500
Not in Commercial Distribution

  • 08714729774440 ()
M004SVGA500

  • Electrical-only medical device connection cable, reusable
Remote Control Cable
BOSTON SCIENTIFIC CORPORATION
M004SVGA250
Not in Commercial Distribution

  • 08714729756811 ()
M004SVGA250

  • Electrical-only medical device connection cable, reusable
CATHETER 239F5 FREEZOR MAX5 LG ORANGE9F
MEDTRONIC, INC.
239F5
In Commercial Distribution

  • 00763000245481 ()

  • Catheter tip length 8mm
  • Length: 90.0 Centimeter
  • Catheter curve length 66mm
  • Catheter shaft size 9 Fr


  • Cardiac cryosurgical system catheter
CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F
MEDTRONIC, INC.
239F3
In Commercial Distribution

  • 00763000245474 ()

  • Length: 90.0 Centimeter
  • Catheter shaft size 9 Fr
  • Catheter curve length 55mm
  • Catheter tip length 8mm


  • Cardiac cryosurgical system catheter
The CROMA Electrosurgical Generator is a tabletop, non-network connected, mains powered Electrosurgical Unit (ESU). The CROMA Electrosurgical Generator is intended to provide Radiofrequency (RF) and microwave (MW) energy for cutting, coagulation, and ablation of soft tissue, when used in conjunction with compatible electrosurgical instruments and accessories. The Creo Medical Electrosurgical System is not intended for use in cardiac procedures.
CREO MEDICAL LIMITED
PRD-EMR-050
In Commercial Distribution

  • 05060359561213 ()
  • 05060359561206 ()
PRD-EMR-050

  • Microwave/electrosurgical system generator
A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.
CREO MEDICAL LIMITED
7-EMR-050 V6.001
In Commercial Distribution

  • 05060359560919 ()
  • 05060359560926 ()
  • 05060359560513 ()
7-EMR-050

  • Microwave/electrosurgical system generator
A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.
CREO MEDICAL LIMITED
7-EMR-050 V6.01
In Commercial Distribution

  • 05060359560513 ()
7-EMR-050

  • Microwave/electrosurgical system generator
A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.
CREO MEDICAL LIMITED
Croma Generator V4.0
In Commercial Distribution

7-EMR-050

  • Microwave/electrosurgical system generator
A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.
CREO MEDICAL LIMITED
Generator 7-EMR-050 with Footswitch 2-EMR-050
Not in Commercial Distribution

  • 05060359560124 ()


  • Microwave/electrosurgical system generator
A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.
CREO MEDICAL LIMITED
Generator 7-EMR-050
Not in Commercial Distribution

  • 05060359560087 ()


  • Microwave/electrosurgical system generator
TAC-S E-FLEX VULCAN
Smith & Nephew, Inc.
7209637
In Commercial Distribution

  • 03596010470683 ()
7209637

  • Radio-frequency ablation system probe, reusable
ABLATOR E-FLEX VULCAN INTEGRATED
Smith & Nephew, Inc.
7209666
In Commercial Distribution

  • 03596010470669 ()
7209666

  • Radio-frequency ablation system probe, reusable
The Acessa ProVu Console Dual Foot Pedal
Hologic, Inc.
MS-06-0171
In Commercial Distribution

  • 15420045515314 ()
MS-06-0171

  • Electromagnetic device tracking/ultrasound guided radio-frequency ablation system console/generator
The Acessa ProVu Console
Hologic, Inc.
7100
In Commercial Distribution

  • 15420045515307 ()
7100

  • Electromagnetic device tracking/ultrasound guided radio-frequency ablation system console/generator
No Description
Gynesonics, Inc.
SW-002
In Commercial Distribution

  • 10817929020340 ()
SW-002

  • Ultrasound-guided radio-frequency ablation system software
C2 CryoBalloon Focal Controller for C2 CryoBalloon Ablation System
C2 THERAPEUTICS, INC.
FG-1012
In Commercial Distribution

  • 00854924006125 ()
FG-1012

  • High-pressure medical gas hose
  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
C2 CryoBalloon Cartridge, Regular, for C2 CryoBalloon Ablation System
C2 THERAPEUTICS, INC.
FG-1010
In Commercial Distribution

  • 00854924006101 ()
FG-1010

  • High-pressure medical gas hose
RF ARTHROSCOPY PROBE ABLATOR MONOPOLAR ABLATION 30DEG BLACK SHAFT
STERILMED, INC.
SMI7209658
Not in Commercial Distribution

  • 10888551034470 ()
SMI7209658

  • Endoscopic electrosurgical electrode, monopolar, single-use
RF ARTHROSCOPY PROBE SAPHYRE BIPOLAR ABLATION 90DEG GRAY SHAFT
STERILMED, INC.
SMI7209686
Not in Commercial Distribution

  • 10888551034500 ()
SMI7209686

  • Endoscopic electrosurgical electrode, bipolar, reprocessed
RF ARTHROSCOPY PROBE ABLATOR MONOPOLAR ABLATION 90DEG BLACK SHAFT
STERILMED, INC.
SMI7209659
Not in Commercial Distribution

  • 10888551034487 ()
SMI7209659

  • Endoscopic electrosurgical electrode, monopolar, single-use
X EP System TactiFlex Ablation Cath, SE Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-03
In Commercial Distribution

  • 05415067047861 ()
ENSITE-TFM-03

  • Cardiac mapping system application software
X EP System TactiFlex Ablation Catheter, SE Software License
ST. JUDE MEDICAL, INC.
ENSITE-TF-02
In Commercial Distribution

  • 05415067046659 ()
ENSITE-TF-02

  • Cardiac mapping system application software
VenaCure 400 Micron Perforator and Accessory Vein Ablation Kit
ANGIODYNAMICS, INC.
EVLTPVAKUS
In Commercial Distribution

  • H787EVLTPVAKUS0 ()
  • H787EVLTPVAKUS5 ()

  • Outer Diameter: 1.5 Millimeter
  • Needle Gauge: 21 Gauge


  • Varicose vein lasing procedure kit
Ablation Connection Box - IntellaNav StablePoint™ (for INTELLAGEN™)
BOSTON SCIENTIFIC CORPORATION
M004RA63020
In Commercial Distribution

  • 00191506020798 ()
M004RA63020

  • Cardiac mapping system
Pack Vein Ablation F/ AZ Vein and Laser Institute
HENRY SCHEIN, INC.
5704224
In Commercial Distribution

  • 00304040188279 ()
  • 10304040188276 ()
5704224

  • General surgical procedure kit, non-medicated, single-use
Pack Vein Ablation F/ AZ Vein and Laser Institute
HENRY SCHEIN, INC.
5703711
In Commercial Distribution

  • 00304040180143 ()
  • 10304040180140 ()
5703711

  • General surgical procedure kit, non-medicated, single-use
Fiber Cord Assembly Remote
ST. JUDE MEDICAL, INC.
H701339
In Commercial Distribution

  • 05415067013392 ()
H701339

  • Electrical-only medical device connection cable, reusable
Fiber Cord Assembly Remote
ST. JUDE MEDICAL, INC.
H701338
In Commercial Distribution

  • 05415067013385 ()
H701338

  • Electrical-only medical device connection cable, reusable
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