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 Class Implantable

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Elite HA Android Package - Beige
HEARING LAB TECHNOLOGY, LLC
546*
In Commercial Distribution

  • 00810068830286 ()
HLT-ELITE-A-BG

  • Air-conduction hearing aid, receiver-in-the-ear
Pro HA Android Package - Grey
HEARING LAB TECHNOLOGY, LLC
246*
In Commercial Distribution

  • 00810068830248 ()
HLT-PRO-A-GR

  • Air-conduction hearing aid, receiver-in-the-ear
Pro HA Android Package - Black
HEARING LAB TECHNOLOGY, LLC
246*
In Commercial Distribution

  • 00810068830231 ()
HLT-PRO-A-BK

  • Air-conduction hearing aid, receiver-in-the-ear
Pro HA Android Package - Beige
HEARING LAB TECHNOLOGY, LLC
246*
In Commercial Distribution

  • 00810068830224 ()
HLT-PRO-A-BG

  • Air-conduction hearing aid, receiver-in-the-ear
MY TSF HOMECARE APP ANDROID
Smith & Nephew, Inc.
71075403
In Commercial Distribution

  • 00885556808016 ()
71075403

  • Wireless patient monitor/sensor reporting software, layperson-use
PROSTHETIC RETAIN SCREW 1.25MM F/CIN & UBIV STD ABUT 14TL TI6AL4VELI
ACE SURGICAL SUPPLY CO., INC.
19522002
In Commercial Distribution

  • 00614950004447 ()

  • Width: 1.25 Millimeter
19522002

  • Screw endosteal dental implant, one-piece
Personal Use Kit OC-Auto, Custom Kit for Cin Labs of Hawaii
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-SLHI
In Commercial Distribution

  • 00816917021157 ()


  • Faecal occult blood IVD, reagent
Cochlear Baha Control App for Android
Cochlear Bone Anchored Solutions AB
95460
In Commercial Distribution

  • 09321502036399 ()
95460

  • Hearing aid/implant system remote control
Hearing Implant Software for Android Devices
COCHLEAR LIMITED
P1860864
In Commercial Distribution

  • 09321502065757 ()
P2006652

  • Audiometric/hearing device software
Kosmos OTS Android Doppler Software Package
ECHONOUS, INC.
P007701
In Commercial Distribution

  • 09353278000700 ()


  • Ultrasound imaging system application software
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