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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Siemens HA CARAT A 3BX BRN Hearing Aid
Ws Audiology Usa, Inc.
HA CARAT A 3BX BRN
Not in Commercial Distribution

  • 04047622006566 ()
10828774

  • Air-conduction hearing aid, behind-the-ear
Siemens HA CARAT A 3BX BG Hearing Aid
Ws Audiology Usa, Inc.
HA CARAT A 3BX BG
Not in Commercial Distribution

  • 04047622006542 ()
10828772

  • Air-conduction hearing aid, behind-the-ear
Siemens UNITY 3 HDA300 HEADSET
Ws Audiology Usa, Inc.
UNITY 3 HDA300 HEADSET
Not in Commercial Distribution

  • 57117810000804 ()
10825966

  • Audiometric/hearing aid tester
Siemens UNITY 3 REAL EAR FULL PACKAGE
Ws Audiology Usa, Inc.
UNITY 3 REAL EAR FULL PACKAGE
Not in Commercial Distribution

  • 57117810000781 ()
10824335

  • Audiometric/hearing aid tester
Siemens UNITY 3 CLINICAL
Ws Audiology Usa, Inc.
UNITY 3 CLINICAL
Not in Commercial Distribution

  • 57117810000767 ()
10824333

  • Audiometric/hearing aid tester
Siemens UNITY 3 HDA200 HEADSET
Ws Audiology Usa, Inc.
UNITY 3 HDA200 HEADSET
Not in Commercial Distribution

  • 57117810000071 ()
10823937

  • Audiometric/hearing aid tester
Siemens UNITY 3 HIGH FREQUENCY
Ws Audiology Usa, Inc.
UNITY 3 HIGH FREQUENCY
Not in Commercial Distribution

  • 57117810000774 ()
10824334

  • Audiometric/hearing aid tester
Siemens UNITY 3 STANDARD WITH INSERTS
Ws Audiology Usa, Inc.
UNITY 3 STANDARD WITH INSERTS
Not in Commercial Distribution

  • 57117810000750 ()
10824332

  • Audiometric/hearing aid tester
Siemens UNITY 3 WITH INSERTS
Ws Audiology Usa, Inc.
UNITY 3 WITH INSERTS
Not in Commercial Distribution

  • 57117810000743 ()
10824331

  • Audiometric/hearing aid tester
Siemens UNITY 3 STANDARD PACKAGE
Ws Audiology Usa, Inc.
UNITY 3 STANDARD PACKAGE
Not in Commercial Distribution

  • 57117810000736 ()
10824330

  • Audiometric/hearing aid tester
Siemens UNITY 3 ER 3A (REFURBISHED)
Ws Audiology Usa, Inc.
UNITY 3 ER 3A (REFURBISHED)
Not in Commercial Distribution

  • 57117810000125 ()
10933228

  • Audiometric/hearing aid tester
Siemens UNITY 3 DD45 (REFURBISHED)
Ws Audiology Usa, Inc.
UNITY 3 DD45 (REFURBISHED)
Not in Commercial Distribution

  • 57117810000101 ()
10933230

  • Audiometric/hearing aid tester
Siemens HA SIRION 2 SP GR Hearing Aid
Ws Audiology Usa, Inc.
HA SIRION 2 SP GR
Not in Commercial Distribution

  • 04038953854131 ()
10937281

  • Air-conduction hearing aid, behind-the-ear
Siemens HA SIRION 2 SP DEMO BG Hearing Aid
Ws Audiology Usa, Inc.
HA SIRION 2 SP DEMO BG
Not in Commercial Distribution

  • 04038953854124 ()
10940187

  • Air-conduction hearing aid, behind-the-ear
Siemens HA SIRION 2 SP DBR Hearing Aid
Ws Audiology Usa, Inc.
HA SIRION 2 SP DBR
Not in Commercial Distribution

  • 04038953854117 ()
10937280

  • Air-conduction hearing aid, behind-the-ear
Siemens HA SIRION 2 SP BG Hearing Aid
Ws Audiology Usa, Inc.
HA SIRION 2 SP BG
Not in Commercial Distribution

  • 04038953854100 ()
10937279

  • Air-conduction hearing aid, behind-the-ear
Siemens HA INTUIS 2 SP GR Hearing Aid
Ws Audiology Usa, Inc.
HA INTUIS 2 SP GR
Not in Commercial Distribution

  • 04038953854025 ()
10937284

  • Air-conduction hearing aid, behind-the-ear
Siemens HA INTUIS 2 SP DEMO BG Hearing Aid
Ws Audiology Usa, Inc.
HA INTUIS 2 SP DEMO BG
Not in Commercial Distribution

  • 04038953854018 ()
10940188

  • Air-conduction hearing aid, behind-the-ear
Siemens HA INTUIS 2 SP DBR Hearing Aid
Ws Audiology Usa, Inc.
HA INTUIS 2 SP DBR
Not in Commercial Distribution

  • 04038953854001 ()
10937283

  • Air-conduction hearing aid, behind-the-ear
Siemens HA INTUIS 2 SP BG Hearing Aid
Ws Audiology Usa, Inc.
HA INTUIS 2 SP BG
Not in Commercial Distribution

  • 04038953853998 ()
10937282

  • Air-conduction hearing aid, behind-the-ear
Siemens ECHARGER 13-M U.S. NTS. Hearing aid accessory.
Ws Audiology Usa, Inc.
ECHARGER 13-M U.S. NTS
Not in Commercial Distribution

  • 04038953848833 ()
10827876

  • Air-conduction hearing aid, behind-the-ear
Siemens CHARGER 312-L U.S NTS. Hearing aid accessory.
Ws Audiology Usa, Inc.
CHARGER 312-L U.S NTS
Not in Commercial Distribution

  • 04038953848802 ()
10822081

  • Air-conduction hearing aid, behind-the-ear
Description: 0.75% CO, 2.1% O2, BAL. N2 - PGS; Cylinder: K; Valve: CGA 500; For calibration of medical analyzers in accordance with manufacturer's instructions.
AIRGAS USA LLC
Calibration Gas
In Commercial Distribution

  • 00819601022133 ()

  • Pressure: 1305 Pound per Square Inch
  • Total Volume: 4400 Liter
Z03NI978300C001

  • Multiple blood gas analyte IVD, calibrator
SIEMENS Leg Holder
HILL-ROM, INC.
102001
In Commercial Distribution

  • 00615521017927 ()
I-LHSMNS

  • Heel stirrup
SIEMENS SECUREFIT BAR
Bionix Radiation Therapy, LLC
UTRT-5016
Not in Commercial Distribution

  • 00817740020836 ()
UTRT-5016

  • Vacuum-mould patient positioning system
Siemens Compatible, 0.7M
Orantech Inc.
IBPA-SM-SM07
In Commercial Distribution

  • 06941691964919 ()


  • Electrical-only medical device connection cable, reusable
Siemens Compatible, 2.4M
Orantech Inc.
SA-027-24
In Commercial Distribution

  • 06941691924838 ()


  • Electrical-only medical device connection cable, reusable
SIEMENS SHIELD SPECIAL
AADCO MEDICAL, INC.
S-306
In Commercial Distribution

  • 00840348508635 ()
S-306

  • Radiation shielding panel, portable/mobile
SpO2-Silikon-Fingersensor zu Dräger /Siemens Erw., Siemens 7pin 300 cm
Unimed Medical Supplies, Inc.
GS SX-1011SIE
In Commercial Distribution

  • 06936735489169 ()


  • Pulse oximeter probe, reusable
Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Navigation Workstation. The Niobe MNS with Navigant NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction
Stereotaxis, Inc.
ES Siemens
In Commercial Distribution

  • M58800100600010 ()
001-006000-1

  • Cardiac mapping system workstation
FLUOROSCOPY 3D-ADAPTER SIEMENS ISO-C
Stryker Leibinger GmbH & Co. KG
6004-400-020
In Commercial Distribution

  • 04546540424549 ()
6004-400-020

  • Multi-purpose stereotactic surgery system
One-piece ECG Cable Siemens
Unimed Medical Supplies, Inc.
23135RP
In Commercial Distribution

  • 06936735468478 ()


  • Electrocardiographic lead set, reusable
Siemens Siecrist SM-1 Cable
Advantage Medical Electronics, LLC
CB-2462242
In Commercial Distribution

  • 00849593010221 ()


  • Electrical-only medical device connection cable, reusable
SIEMENS PERCEPTOR CABLE 12'
NAVILYST MEDICAL, INC.
70041206
In Commercial Distribution

  • H965700412060 ()

  • Length: 12 Feet


  • Invasive-pressure external transducer, single-use
SIEMENS PERCEPTOR CABLE 12'
NAVILYST MEDICAL, INC.
70041204
In Commercial Distribution

  • H965700412040 ()

  • Length: 12 Feet


  • Invasive-pressure external transducer, single-use
SIEMENS PERCEPTOR CABLE 6'
NAVILYST MEDICAL, INC.
70040616
In Commercial Distribution

  • H965700406160 ()

  • Length: 6 Feet


  • Invasive-pressure external transducer, single-use
SIEMENS PERCEPTOR CABLE 6'
NAVILYST MEDICAL, INC.
70040614
In Commercial Distribution

  • H965700406140 ()

  • Length: 6 Feet


  • Invasive-pressure external transducer, single-use
Siemens IBP Simulator Cable
Advantage Medical Electronics, LLC
CB-91033
In Commercial Distribution

  • 00849593021289 ()


  • Electrical-only medical device connection cable, reusable
Bracket rail - Drager / Siemens
FISHER & PAYKEL HEALTHCARE LIMITED
900MR088
In Commercial Distribution

  • 09420012406071 ()
900MR088

  • Medical device service rail clamp
CABLE ASSEMBLY,EW10PIN/SIEMENS
Edwards Lifesciences LLC
PX1800
In Commercial Distribution

  • 00690103195491 ()

  • Length: 162 Inch
896013021

  • Electrical-only medical device connection cable, reusable
Grid L-frame, GE/Siemens
Nucletron B.V.
189206P01-00
In Commercial Distribution

  • 08717213017603 ()
  • 08717213039933 ()


  • Prostate brachytherapy system applicator, remote-afterloading
Quantum Overlay - Siemens PHS1B
Qfix
RT-4550SS4
In Commercial Distribution

  • 10841962109069 ()

  • Length: 215 Centimeter
RT-4550SS4

  • Indexed-immobilization patient positioning system
kVue CT Overlay, Siemens
Qfix
RT-4550KVSS4
In Commercial Distribution

  • 10841962108994 ()

  • Length: 212 Centimeter
RT-4550KVSS4

  • Indexed-immobilization patient positioning system
Protura, Kit, Siemens Txt
MEDTEC, INC.
206X120
Not in Commercial Distribution

  • 00841439101957 ()

  • Length: 5 Inch
206X120

  • Indexed-immobilization patient positioning system
SIEMENS PERCEPTOR CABLE 12'
NAVILYST MEDICAL, INC.
64042010
In Commercial Distribution

  • H965640420100 ()

  • Length: 12 Feet


  • Invasive-pressure external transducer, single-use
SIEMENS PERCEPTOR CABLE 12'
NAVILYST MEDICAL, INC.
64000997
In Commercial Distribution

  • H965640009970 ()

  • Length: 12 Feet


  • Invasive-pressure external transducer, single-use
MR-ADAPTER SIEMENS TxRx HEADCOIL
Elekta Instrument AB
1016899
In Commercial Distribution

  • 07340048306331 ()


  • Neurological stereotactic surgery system
MR-ADAPTER SIEMENS CONICAL HEADCOIL
Elekta Instrument AB
A0420-24
In Commercial Distribution

  • 07340048300933 ()


  • Neurological stereotactic surgery system
MR-ADAPTER SIEMENS TxRx CP
Elekta Instrument AB
1014734
In Commercial Distribution

  • 07340048306324 ()


  • Neurological stereotactic surgery system
PAD, TABLE, UROLOGY, SIEMENS
DOMICO MED-DEVICE, LLC
27191
In Commercial Distribution

  • 00810050241595 ()


  • Multifunction body cushion
  • Radiological general body-part positioner
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