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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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AMA Optics Digital Vision Test - G506DG010

A digital vision testing system intended as an aid in assessment of visual function in patients. The software delivers algorithms that utilize a visual display which may be a tablet, smart phone, a computer screen, etc.
AMA Optics, Inc.
DiagnosticGame
In Commercial Distribution

  • G506DG010 ()
DG01

  • Vision self-testing software

CamX Spectra Caries Detection Aid - D678G41000

The CamX Spectra Fluorescence Caries Detection Aid System aids in the diagnosis of caries. It consists of a toothbrush-sized handpiece for examining the condition of a tooth, an umbilical cord connecting the handpiece to a computer and imaging software.
AIR TECHNIQUES, INC.
G4100
In Commercial Distribution

  • D678G41000 ()
  • D678G40001 ()
  • DG78G41001 ()


  • Dental caries detector, optical induced fluorescence

Sight OLO - B787OLOU10

The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion.
S.D. SIGHT DIAGNOSTICS LTD
OLO-U1
Not in Commercial Distribution

  • B787OLOU10 ()


  • Haematological cell analyser IVD

Ax® - M711LS3090

SST
Innovasis, Inc.
LS-309
In Commercial Distribution

  • M711LS3090 ()


  • Orthopaedic implant driver
  • Surgical screwdriver, reusable

Excella II® - M711LS1600

Al, Silicone, SST
Innovasis, Inc.
LS-160
In Commercial Distribution

  • M711LS1600 ()


  • Orthopaedic implant driver
  • Surgical screwdriver, reusable

Opteryx® - M711CI0100

Radel, SST
Innovasis, Inc.
CI-010
In Commercial Distribution

  • M711CI0100 ()
CI-010

  • Orthopaedic implant driver
  • Surgical screwdriver, reusable

Sleeve, SG-Screwdriver - M739154000092

No Description
CAPTIVA SPINE, INC.
15400-0092
In Commercial Distribution

  • M739154000092 ()


  • Orthopaedic implantation sleeve, reusable
  • Surgical screwdriver, reusable

Universal Screwdriver - Sleeve - M73921010024

No Description
CAPTIVA SPINE, INC.
2101-0024
In Commercial Distribution

  • M73921010024 ()


  • Orthopaedic implantation sleeve, reusable
  • Surgical screwdriver, reusable

Tall Separable Fastener 10-Pack, w/ Cementation Aid, Ditron - D990DDUSTSFCA10PK0

No Description
SMART DENTURE CONVERSIONS, LLC
DDUS-TSFCA10PK
In Commercial Distribution

  • D990DDUSTSFCA10PK0 ()


  • Surgical screwdriver, reusable
  • Dental prosthesis/implant abutment screw analog, single-use

Shukla Shoulder S9SHLDR - B756SXT037060

Threaded Extractor Driver, M8 X 1.0 - 6G
Shukla Medical
SXT037-06
In Commercial Distribution

  • B756SXT037060 ()


  • Surgical screwdriver, reusable
  • Orthopaedic inorganic implant inserter/extractor, reusable
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