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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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Ultrasound Doppler Device
Compumedics Germany GmbH
MDX R12
In Commercial Distribution

  • 04260493310017 ()
7880

  • Invasive vascular ultrasound system
  • Noninvasive vascular ultrasound system, line-powered
“X” Osteotome, 7mm
SYMMETRY MEDICAL INC.
10-008-400
In Commercial Distribution

  • 00847538006360 ()
2709-01-010

  • Orthopaedic osteotome
“X” Osteotome, 7mm
SYMMETRY MEDICAL INC.
10-008-000
In Commercial Distribution

  • 00847538001235 ()
00-9986-010-17;00-9986-010-17

  • Orthopaedic osteotome
DEVICE IDENTIFIER, MAIN ASSY, X SERIES ADVANCED MONITOR/DEFIBRILLATOR, 12 LEAD W/INTERP, PACE, NO VOICE, ETCO2, NIBP, BVM, IBP, NIBP, SPO2, SPCO, SPMET (RAINBOW/MASIMO), CPR EXPANSION PACK, MOBILE STREAMING, GERMAN
Zoll Medical Corporation
630-2241712-08
In Commercial Distribution

  • 00847946049959 ()

  • 8.9" x 10.4" x 8.75"


  • Physiologic-monitoring defibrillation system
STENT SFR4-6-40-10 V01 US
Micro Therapeutics, Inc.
SFR4-6-40-10
In Commercial Distribution

  • 00847536034730 ()


  • Thrombectomy wire-net
STENT SFR4-6-20-10 V01 US
Micro Therapeutics, Inc.
SFR4-6-20-10
In Commercial Distribution

  • 00847536034716 ()


  • Thrombectomy wire-net
Single-lead ECG monitor intended to capture, store, transmit and display electrocardiogram (ECG) information for long term monitoring and evaluation.
FOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITED
Frontier X Plus
In Commercial Distribution

  • 08908013617128 ()


  • Electrocardiographic long-term ambulatory recording analyser
  • Telemetric electrocardiographic ambulatory recorder
  • Electrocardiograph, home-use
Stainless Steel. Used to replicate the position of the implant in a working implant cast. Made from Stainless steel.
STERNGOLD DENTAL LLC
904547
In Commercial Distribution

  • 00841549117374 ()


  • Dental implant analog
GRYPHON FLEX X DISPOSABLE INSTRUMENT KIT
Medos International Sàrl
271079
In Commercial Distribution

  • 10886705033294 ()
271079

  • Orthopaedic surgical procedure kit, non-medicated, single-use
GRYPHON FLEX X DRILL REUSABLE
Medos International Sàrl
271076
In Commercial Distribution

  • 10886705033263 ()
271076

  • Fluted surgical drill bit, single-use
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