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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Patient Interface Kit for VICTUS™ Femtosecond Laser Platform (software version 2.7 and higher). Kit consists of Patient Interface 125 and Suction Clip 125.
Technolas Perfect Vision GmbH
1
Not in Commercial Distribution

  • 04050555000990 ()
90000115

  • Laser beam delivery unit holder
Canturio® Smart Extension 14mm (D) x 30mm (H) with Canary Health Implanted Reporting Processor (CHIRP®) system is a tibial extension implant containing electronics and software.
Canary Medical USA LLC
43-5570-030-14
In Commercial Distribution

  • 00860003118399 ()


  • Knee femur stem prosthesis
Tandem t:slim TRUSTL PK10 23"
Tandem Diabetes Care, Inc.
1017101
In Commercial Distribution

  • 00389152710174 ()


  • Ambulatory insulin infusion pump reservoir
  • Electric infusion pump administration set, single-use
  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
Tandem t:slim ASFTXC PK10 23"
Tandem Diabetes Care, Inc.
1017095
In Commercial Distribution

  • 00389152709574 ()


  • Ambulatory insulin infusion pump reservoir
  • Electric infusion pump administration set, single-use
  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
Tandem tslim ASFT30 PK10 23"
Tandem Diabetes Care, Inc.
1017089
In Commercial Distribution

  • 00389152708973 ()


  • Ambulatory insulin infusion pump reservoir
  • Electric infusion pump administration set, single-use
  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
Tandem t:slim ASFTXC PK14 23"
Tandem Diabetes Care, Inc.
1017083
In Commercial Distribution

  • 00389152708379 ()


  • Ambulatory insulin infusion pump reservoir
  • Electric infusion pump administration set, single-use
  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
Tandem t:slim ASFT30 PK14 23"
Tandem Diabetes Care, Inc.
1017076
In Commercial Distribution

  • 00389152707679 ()


  • Ambulatory insulin infusion pump reservoir
  • Electric infusion pump administration set, single-use
  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
No Description
CLEAR GUIDE MEDICAL, INC.
CGTT
In Commercial Distribution

  • B201CGTT1 ()
  • B201CGTT0 ()
  • B201CGTT2 ()


  • Imaging lesion localization marker, external, single-use
  • Surgical optical-tracking spatial marker, single-use
Sterile Disposable Endocavity Needle Guide Kit for use with Alpinion E3-10, BK Medical 8819 & E10C4, Carestream E10C4 & E14C4, Hitachi Aloka Medical UST-679, Philips BP10-5ec (Affiniti 50, Affiniti 70, HD11, HD115 & HD7XE systems) & C9-4ec (HD7 XE w/3.0.1, software and above & HD9 systems) and Samsung Medison NEV4-9ES & NER4-9ES Ultrasound Transducers
PROTEK MEDICAL PRODUCTS, INC.
5252
In Commercial Distribution

  • 10841912106070 ()
  • 00841912106073 ()
5252

  • Body-orifice ultrasound imaging transducer cover, basic
  • Needle guide, single-use
Sterile Disposable Endocavity Needle Guide Kit for use with Alpinion E3-10, BK Medical 8819 & E10C4, CareStream E10C4 & E14C4, HItachi Aloka Medical UST-679, Philips BP10-5ec (Affiniti 50, Affiniti 70, HD11, HD115 & HD7XE systems) & C9-4ec (HD7 XE w/3.0.1, software and above & HD9 systems), and Samsung Medison NEV4-9ES & NER4-9ES Ultrasound Transducers
PROTEK MEDICAL PRODUCTS, INC.
5253
In Commercial Distribution

  • 10841912105172 ()
  • 00841912105175 ()
5253

  • Body-orifice ultrasound imaging transducer cover, basic
  • Needle guide, single-use
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