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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20-23 GA Tapered Blunt Tip
Beaver-Visitec International, Inc.
221266
In Commercial Distribution

  • 30886158010532 ()
  • 00886158010531 ()


  • Electrosurgical system
20-23 GA Tapered Fine Tip
Beaver-Visitec International, Inc.
221265
In Commercial Distribution

  • 30886158010525 ()
  • 00886158010524 ()


  • Electrosurgical system
Band Bag 20" X 23"
STERIMED LLC
2023
In Commercial Distribution

  • 20850341007206 ()
  • 10850341007209 ()
  • 00850341007202 ()


  • X-ray system cover
No Description
MASIMO CORPORATION
2023
In Commercial Distribution

  • 00843997011150 ()


  • Electrical-only medical device connection cable, reusable
Calibration Standard Metanephrines
Chromsystems Instruments + Chemicals GmbH
2023
In Commercial Distribution

  • 04250317503114 ()

  • 10ml
2023

  • Multiple biogenic amine neurotransmitter IVD, calibrator
No Description
PROTEK MEDICAL PRODUCTS, INC.
2023
In Commercial Distribution

  • 10841912106872 ()
  • 00841912106875 ()
2023

  • Intraoperative ultrasound imaging transducer cover
GEN4 Direct Access
CURBELL MEDICAL PRODUCTS, INC.
4C380U-Z103008
In Commercial Distribution

  • 00840828108041 ()
2023

  • Pillow speaker
truSculpt iD RF Device (Rebranded as truSculpt RF Device in June 2023)
CUTERA, INC.
truSculpt iD
In Commercial Distribution

  • 00816722021427 ()


  • Radio-frequency skin contouring system
TLIF(B) Trial L36 x W9 x H9
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557206031 ()
TI.2023

  • Spinal implant trial
No Description
MedicalCommunications GmbH
2023 (Build 2088)
In Commercial Distribution

  • 04260648620039 ()


  • Ophthalmology PACS software
  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
Radiography 7000 M digital mobile is a new motorized mobile x-ray system that includes: 1. Base Unit ( Sedecal Mobile X-ray system - SM-IV, cleared under K232185 August 21, 2023) 2. SkyPlate Family of detectors (Wireless Portable Detectors) and their accessories 3. Eleva WorkSpot In addition, the following accessories can be used together with the system - Raidography 7000 M: - Detector Holder f. Patient Bed - Grid Landsc. SkyPlateE Large - Grid Landscape SkyPlate Large - Grid Portr. SkyPlate E Large - Grid Portrait SkyPlate Large - Grid Portrait SkyPlate Small - Handle for Skyplate Large - Portable Panel Protector - Wireless Detect. Mobile Holder - Set of 50 WPD Hygienic Bags (large) - Set of 50 WPD Hygienic Bags (small)
Philips Medical Systems DMC GmbH
712010
In Commercial Distribution

  • 00884838115521 ()


  • Mobile basic diagnostic x-ray system, digital
No Description
INVACARE CORPORATION
IHRAILAB-DLX
Not in Commercial Distribution

  • 00841447102373 ()


  • Bedrail
VENCLOSE PROCEDURE PACK, MAVEN
MEDLINE INDUSTRIES, INC.
VC-PPM-12F
In Commercial Distribution

  • 40193489422680 ()
  • 10193489422689 ()
VC-PPM-12F

  • General surgical procedure kit, non-medicated, single-use
VENCLOSE PROCEDURE PACK, 12CM
MEDLINE INDUSTRIES, INC.
VC-PPH-6F12A
In Commercial Distribution

  • 40193489423106 ()
  • 10193489423105 ()
VC-PPH-6F12A

  • General surgical procedure kit, non-medicated, single-use
VENCLOSE PROCEDURE PACK, 7CM
MEDLINE INDUSTRIES, INC.
VC-PPH-6F7A
In Commercial Distribution

  • 40193489423090 ()
  • 10193489423099 ()
VC-PPH-6F7A

  • General surgical procedure kit, non-medicated, single-use
VENCLOSE MICRO INTRO KIT, 12CM
MEDLINE INDUSTRIES, INC.
VC-ISH-6F12
In Commercial Distribution

  • 40193489377355 ()
  • 10193489377354 ()
VC-ISH-6F12

  • General surgical procedure kit, non-medicated, single-use
VENCLOSE MICRO INTRO KIT, 7CM
MEDLINE INDUSTRIES, INC.
VC-ISH-6F7
In Commercial Distribution

  • 40193489377195 ()
  • 10193489377194 ()
VC-ISH-6F7

  • General surgical procedure kit, non-medicated, single-use
Disposable High-Temperature (2000° C) Loop Tip Cautery battery operated with batteries installed. Unit has a four year shelf life.
SHIPPERT MEDICAL TECHNOLOGIES, INC
Cautery High Temperature Loop Tip
Not in Commercial Distribution

  • 00893398002547 ()
  • 10893398002544 ()

  • Loop Tip
20-HM-1000

  • Electrocautery system handpiece
Disposable High-Temperature (2000° C) Fine Tip Cautery battery operated with batteries installed. Unit has a four year shelf life.
SHIPPERT MEDICAL TECHNOLOGIES, INC
Cautery High Temperature Fine Tip
Not in Commercial Distribution

  • 00893398002530 ()
  • 10893398002537 ()

  • Fine Tip
20-HM-2000

  • Electrocautery system handpiece
Sterile Tubing for use as fat harvesting tubing or fat transfer tubing
SHIPPERT MEDICAL TECHNOLOGIES, INC
Tubing, Transparent, Yellow Stripe
Not in Commercial Distribution

  • 00893398002363 ()
05-SRTUBINGY312-500

  • Surgical suction system collection container, single-use
Tube to transfer harvested fat to a reinjection syringe
SHIPPERT MEDICAL TECHNOLOGIES, INC
Tissu-Trans Transfer Tube
Not in Commercial Distribution

  • 00893398002349 ()
3-TT-Transfer Tube

  • Surgical suction system collection container, single-use
Adaptor to fit the "L" connector to allow attachment of customer supplied harvest tubing
SHIPPERT MEDICAL TECHNOLOGIES, INC
Tissu-Trans Special Tubing Adaptor
Not in Commercial Distribution

  • 00893398002332 ()
3-TT-Adaptor

  • Surgical suction system collection container, single-use
Syringes for Additional Collection, Decantation and Re-injection of Autologous Tissue.
SHIPPERT MEDICAL TECHNOLOGIES, INC
Tissu-Trans 60cc Syringe Refill Kit
Not in Commercial Distribution

  • 00893398002318 ()
3-TT-SFILL360-REFILL

  • Surgical suction system collection container, single-use
Syringes for Collection, Decantation and Re-injection of Autologous Tissue.
SHIPPERT MEDICAL TECHNOLOGIES, INC
Linear Syringe Fill 60X3
Not in Commercial Distribution

  • 00893398002295 ()
3-TT-SFL60x3

  • Surgical suction system collection container, single-use
Syringe for Collection, Decantation and Re-injection of Autologous Tissue.
SHIPPERT MEDICAL TECHNOLOGIES, INC
Linear Syringe Fill 60
Not in Commercial Distribution

  • 00893398002288 ()
3-TT-SFL60

  • Surgical suction system collection container, single-use
Canister for Collection, Decantation and Re-injection of Autologous Tissue
SHIPPERT MEDICAL TECHNOLOGIES, INC
Tissu-Trans MEGA 1500
Not in Commercial Distribution

  • 00893398002271 ()

  • cc
3-TT-MEGA 1500

  • Surgical suction system collection container, single-use
Canister for Collection, Filtration and Re-injection of Autologous Tissue
SHIPPERT MEDICAL TECHNOLOGIES, INC
Tissu-Trans Filtron 2000cc
Not in Commercial Distribution

  • 00893398002264 ()

  • cc
3-TT-FILTRON 2000

  • Surgical suction system collection container, single-use
Canister for Collection, Filtration and Re-injection of Autologous Tissue
SHIPPERT MEDICAL TECHNOLOGIES, INC
Tissu-Trans Filtron 1000cc
Not in Commercial Distribution

  • 00893398002257 ()

  • cc
3-TT-FILTRON 1000

  • Surgical suction system collection container, single-use
Canister for Collection, Filtration and Re-injection of Autologous Tissue
SHIPPERT MEDICAL TECHNOLOGIES, INC
Tissu-Trans Filtron 500cc
Not in Commercial Distribution

  • 00893398002240 ()

  • cc
3-TT-FILTRON 500

  • Surgical suction system collection container, single-use
Syringes for Collection, Decantation and Re-injection of Autologous Tissue
SHIPPERT MEDICAL TECHNOLOGIES, INC
Tissu-Trans Syringe Fill 360
Not in Commercial Distribution

  • 00893398002233 ()

  • cc
3-TT-SFILL 360

  • Surgical suction system collection container, single-use
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