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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Intraoral Camera
GOOD DOCTORS CO., LTD.
IC-WHMA90
In Commercial Distribution

  • 18800025400149 ()
  • 08800025400142 ()


  • Surgical video camera
Cardiofax M Electrocardiograph, 12 lead with interpretation
NIHON KOHDEN AMERICA, INC.
ECG-1350A
In Commercial Distribution

  • 00841983102394 ()
ECG-1350A

  • Electrocardiograph, professional, multichannel
A&M HA A&M AURORA 2 XP BG Hearing Aid
Ws Audiology Usa, Inc.
HA A&M AURORA 2 XP BG
Not in Commercial Distribution

  • 04046355206427 ()
10299904

  • Air-conduction hearing aid, behind-the-ear
A&M HA A&M AURORA 2 P BG Hearing Aid
Ws Audiology Usa, Inc.
HA A&M AURORA 2 P BG
Not in Commercial Distribution

  • 04046355206403 ()
10299902

  • Air-conduction hearing aid, behind-the-ear
A&M HA A&M AURORA 4 PRO P BG Hearing Aid
Ws Audiology Usa, Inc.
HA A&M AURORA 4 PRO P BG
Not in Commercial Distribution

  • 04046355205901 ()
10298390

  • Air-conduction hearing aid, behind-the-ear
A&M HA A&M AURORA 4 PRO OPEN BG Hearing Aid
Ws Audiology Usa, Inc.
HA A&M AURORA 4 PRO OPEN BG
Not in Commercial Distribution

  • 04046355205888 ()
10298388

  • Air-conduction hearing aid, behind-the-ear
A&M HA A&M DIGITRIM 12 S BG Hearing Aid
Ws Audiology Usa, Inc.
HA A&M DIGITRIM 12 S BG
Not in Commercial Distribution

  • 04046355339736 ()
10423210

  • Air-conduction hearing aid, behind-the-ear
A&M HA A&M AURORA 4 PRO XP BG Hearing Aid
Ws Audiology Usa, Inc.
HA A&M AURORA 4 PRO XP BG
Not in Commercial Distribution

  • 04046355296480 ()
10600013

  • Air-conduction hearing aid, behind-the-ear
A&M HA A&M AURORA 2 S BG Hearing Aid
Ws Audiology Usa, Inc.
HA A&M AURORA 2 S BG
Not in Commercial Distribution

  • 04046355296404 ()
10426198

  • Air-conduction hearing aid, behind-the-ear
A&M HA A&M DIGITRIM 23 S BG Hearing Aid
Ws Audiology Usa, Inc.
HA A&M DIGITRIM 23 S BG
Not in Commercial Distribution

  • 04046355295070 ()
10423091

  • Air-conduction hearing aid, behind-the-ear
A&M HA AM AURORA 8 PRO P BG Hearing Aid
Ws Audiology Usa, Inc.
HA AM AURORA 8 PRO P BG
Not in Commercial Distribution

  • 04046355295025 ()
10426889

  • Air-conduction hearing aid, behind-the-ear
A&M HA AM AURORA 8 PRO OPEN GR Hearing Aid
Ws Audiology Usa, Inc.
HA AM AURORA 8 PRO OPEN GR
Not in Commercial Distribution

  • 04046355294974 ()
10426886

  • Air-conduction hearing aid, behind-the-ear
A&M HA AM AURORA 8 PRO OPEN BG Hearing Aid
Ws Audiology Usa, Inc.
HA AM AURORA 8 PRO OPEN BG
Not in Commercial Distribution

  • 04046355294967 ()
10426884

  • Air-conduction hearing aid, behind-the-ear
A&M HA A&M DIGITRIM 23 XP BG Hearing Aid
Ws Audiology Usa, Inc.
HA A&M DIGITRIM 23 XP BG
Not in Commercial Distribution

  • 04046355294523 ()
10417974

  • Air-conduction hearing aid, behind-the-ear
A&M HA A&M DIGITRIM 12 XP BG Hearing Aid
Ws Audiology Usa, Inc.
HA A&M DIGITRIM 12 XP BG
Not in Commercial Distribution

  • 04046355294479 ()
10417967

  • Air-conduction hearing aid, behind-the-ear
A&M HA A&M DIGITRIM 23 P BG Hearing Aid
Ws Audiology Usa, Inc.
HA A&M DIGITRIM 23 P BG
Not in Commercial Distribution

  • 04046355294424 ()
10302147

  • Air-conduction hearing aid, behind-the-ear
A&M HA A&M DIGITRIM 12 P BG Hearing Aid
Ws Audiology Usa, Inc.
HA A&M DIGITRIM 12 P BG
Not in Commercial Distribution

  • 04046355294387 ()
10302140

  • Air-conduction hearing aid, behind-the-ear
A&M HA A&M AM 111 BG Hearing Aid
Ws Audiology Usa, Inc.
HA A&M AM 111 BG
Not in Commercial Distribution

  • 04046355294370 ()
10302138

  • Air-conduction hearing aid, behind-the-ear
OCTANE M,IMPACTION CAP
Choice Spine, LP
05-049-13-0000
In Commercial Distribution

  • 00840996153607 ()


  • Polymeric spinal interbody fusion cage
OCTANE M,ANGLED POSITIONER
Choice Spine, LP
05-049-11-0000
In Commercial Distribution

  • 00840996153591 ()


  • Polymeric spinal interbody fusion cage
OCTANE M,STRAIGHT POSITIONER
Choice Spine, LP
05-049-10-0000
In Commercial Distribution

  • 00840996153584 ()


  • Polymeric spinal interbody fusion cage
OCTANE M,GRAFT PUSHER
Choice Spine, LP
05-049-09-0000
In Commercial Distribution

  • 00840996153577 ()


  • Polymeric spinal interbody fusion cage
OCTANE M, GRAFT TUBE
Choice Spine, LP
05-049-08-0000
In Commercial Distribution

  • 00840996153560 ()


  • Polymeric spinal interbody fusion cage
OCTANE M,RAIL SHAFT,24MM
Choice Spine, LP
05-049-05-2000
In Commercial Distribution

  • 00840996153539 ()


  • Polymeric spinal interbody fusion cage
OCTANE M,RAIL SHAFT,26MM
Choice Spine, LP
05-049-05-1000
In Commercial Distribution

  • 00840996153522 ()


  • Polymeric spinal interbody fusion cage
OCTANE M,RAIL SHAFTS
Choice Spine, LP
05-049-05-0000
In Commercial Distribution

  • 00840996153515 ()


  • Polymeric spinal interbody fusion cage
OCTANE M,GEAR INSERTER HANDLE
Choice Spine, LP
05-049-04-2000
In Commercial Distribution

  • 00840996153508 ()


  • Polymeric spinal interbody fusion cage
OCTANE M,INSERTER RAIL
Choice Spine, LP
05-049-04-0000
In Commercial Distribution

  • 00840996153492 ()


  • Polymeric spinal interbody fusion cage
OCTANE M,GEAR INSERTER,24MM
Choice Spine, LP
05-049-03-2000
In Commercial Distribution

  • 00840996153485 ()


  • Polymeric spinal interbody fusion cage
OCTANE M,GEAR INSERTER,26MM
Choice Spine, LP
05-049-03-1100
In Commercial Distribution

  • 00840996153478 ()


  • Polymeric spinal interbody fusion cage
OCTANE M,GEAR DRIVE INSERTER
Choice Spine, LP
05-049-03-1000
In Commercial Distribution

  • 00840996153461 ()


  • Polymeric spinal interbody fusion cage
OCTANE M,RATCHET INSERTER HANDLE
Choice Spine, LP
05-049-03-0000
In Commercial Distribution

  • 00840996153454 ()


  • Polymeric spinal interbody fusion cage
M & S DENTAL, Aspirating Syringe, Standard, Medium, STAINLESS
A. TITAN INSTRUMENTS, INC.
ASMS
In Commercial Distribution

  • 00841685104672 ()


  • Dental anaesthesia syringe, reusable
A&M S_ITE XTM IF A4 T3MOC L BG Hearing Aid
Ws Audiology Usa, Inc.
S_ITE XTM IF A4 T3MOC L BG
In Commercial Distribution

  • 04056839014769 ()
10943605

  • Air-conduction hearing aid, in-the-ear
A&M S_ITE XTM IF A4 T3MOC R BG Hearing Aid
Ws Audiology Usa, Inc.
S_ITE XTM IF A4 T3MOC R BG
In Commercial Distribution

  • 04056839014752 ()
10943606

  • Air-conduction hearing aid, in-the-ear
A&M S_ITE XTM IF A4 N-TAN R BG Hearing Aid
Ws Audiology Usa, Inc.
S_ITE XTM IF A4 N-TAN R BG
In Commercial Distribution

  • 04056839013243 ()
10943612

  • Air-conduction hearing aid, in-the-ear
A&M S_ITE XTM IF A4 N-TAN L BG Hearing Aid
Ws Audiology Usa, Inc.
S_ITE XTM IF A4 N-TAN L BG
In Commercial Distribution

  • 04056839013212 ()
10943611

  • Air-conduction hearing aid, in-the-ear
No Description
BIOCARE MEDICAL LLC
IPI3099G10
In Commercial Distribution

  • 00847627008930 ()


  • SOXE protein IVD, antibody
No Description
BIOCARE MEDICAL LLC
IPI3066G10
In Commercial Distribution

  • 00847627008916 ()


  • p40 protein IVD, antibody
No Description
BIOCARE MEDICAL LLC
AVI438G
In Commercial Distribution

  • 00847627005069 ()


  • Paired box protein (PAX) IVD, antibody
No Description
BIOCARE MEDICAL LLC
API438AA
In Commercial Distribution

  • 00847627004901 ()


  • Paired box protein (PAX) IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3120AA
In Commercial Distribution

  • 00847627004239 ()


  • SOXC protein IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3115AA
In Commercial Distribution

  • 00847627004208 ()


  • Adenovirus immunoglobulin G (IgG) antibody IVD, reagent
No Description
BIOCARE MEDICAL LLC
API3111AA
In Commercial Distribution

  • 00847627004178 ()


  • Cadherin protein IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3099H
In Commercial Distribution

  • 00847627004147 ()


  • SOXE protein IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3099AA
In Commercial Distribution

  • 00847627004130 ()


  • SOXE protein IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3066H
In Commercial Distribution

  • 00847627004079 ()


  • p40 protein IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3066AA
In Commercial Distribution

  • 00847627004062 ()


  • p40 protein IVD, antibody
No Description
BIOCARE MEDICAL LLC
ACI438C
In Commercial Distribution

  • 00847627003805 ()


  • Paired box protein (PAX) IVD, antibody
No Description
BIOCARE MEDICAL LLC
ACI438B
In Commercial Distribution

  • 00847627003799 ()


  • Paired box protein (PAX) IVD, antibody
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