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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System for non-invasive tumor ablation within head through Focal Ultrasound (FUS) treatment under Magnetic Resonance (MR) guidance (i.e. MRgFUS) for Siemens MRI scanners.
INSIGHTEC LTD
SYS0004000-BA 4000 Type 1.1
In Commercial Distribution

  • 07290015461092 ()

  • Weight: 1700 Kilogram
EXABLATE 4000 Type 1.1

  • Therapeutic oncological/gynaecological ultrasound system
MPH57991 NUP98 Proximal in Texas Red Spectrum V2 (ASR)
CYTOCELL LIMITED
MPH57991
In Commercial Distribution



  • Assay development analyte-specific reagent IVD
Callisto Bld Mil 0 & V2 LED Preloaded Hdl (Box10)
TIMESCO HEALTHCARE LIMITED
DS.3950.950.30
In Commercial Distribution

  • 05055382851653 ()
  • 05055382851646 ()


  • Rigid intubation laryngoscope, single-use
Callisto Bld Mil 00 & V2 LED Preloaded Hdl (Box10)
TIMESCO HEALTHCARE LIMITED
DS.3950.950.28
In Commercial Distribution

  • 05055382851639 ()
  • 05055382851622 ()


  • Rigid intubation laryngoscope, single-use
VERSAPORT PLUS V2 RT OBTURATOR WITH 5MM PLUS SEAL
STERILMED, INC.
AUT179103P
Not in Commercial Distribution

  • 10888551013246 ()
AUT179103P

  • Laparoscopic access cannula, reprocessed
VERSAPORT PLUS V2 RT OBTURATOR WITH 5MM PLUS SEAL
STERILMED, INC.
AUT179102P
Not in Commercial Distribution

  • 10888551013239 ()
AUT179102P

  • Laparoscopic access cannula, reprocessed
TROCAR VERSAPORT V2 RT OBTURATOR SHORT WITH 5MM SEAL
STERILMED, INC.
AUT179100
Not in Commercial Distribution

  • 10888551013215 ()
AUT179100

  • Laparoscopic trocar blade, reprocessed
Leadwire AMC DIN to Snap, Shld, 51" V2 Yellow
Advantage Medical Electronics, LLC
LW-2090S51V2
In Commercial Distribution

  • 00849593030793 ()


  • Electrocardiographic lead set, reusable
Knurled Spring & Screw for D1/D2/V2 Knee Positioners
Innovative Medical Products, Inc
803-114-SS
In Commercial Distribution

  • 00696588006031 ()
803-114-SS

  • Leg procedure positioner
Troponin T G5 STAT Elecsys cobas e100 V2 (E1G)
Roche Diagnostics GmbH
08469865160
In Commercial Distribution

  • 07613336158951 ()
08469865160

  • Troponin T IVD, reagent
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