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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No Description
Carl Zeiss Meditec AG
7012
In Commercial Distribution

  • 04049539070128 ()


  • Surgical microscope fluorescent angiography system
EXPLORER AIR® II consists of an imaging system that contains two cameras (one (1) for fluorescence, one (1) for color images) suspended by an articulated arm attached to a trolley. A touch screen and secondary monitor are also mounted on the trolley. EXPLORER AIR® II enhances the surgeon’s vision with use of near infrared fluorescence (NIR) imaging. The technology is based on the exposure of the tissue of interest to light after fluorescent dye such as indocyanine green (ICG) or pafolacianine has been administered to the patient. The EXPLORER AIR® II visualizes fluorescence excited by infrared light (740-760nm) and emitted in the band around 800nm. After image acquisition, the composite image (overlay of fluorescence and color images) is displayed along with the fluorescent and color images. The user can tag and compare images, play the recorded videos, and export the selected files. The EXPLORER AIR® II must be used with EXPLORER AIR® Sterile Drape for use under sterile conditions. The EXPLORER AIR® Sterile Drape is manufactured by Exact Medical Manufacturing, Inc., and has been cleared in K101689.
SurgVision GmbH
8003
In Commercial Distribution

  • 04260721460002 ()


  • Surgical microscope fluorescent angiography system
No Description
Luminance Medical Ventures Incorporated
BE-NQUQ-FSF8
In Commercial Distribution

  • 00860002593074 ()


  • Musculoskeletal/physical therapy laser beam guide, transcutaneous
Surgical Exoscope Fluorescence Filter
Synaptive Medical Inc
SYN-0990
In Commercial Distribution

  • 00670082000603 ()


  • Surgical microscope fluorescent angiography system
Legacy Hand Piece 600um Fiber Hand Piece w/ Finger Switch, Dark Gray
LITECURE LLC
PRD-000477-000-04-L
In Commercial Distribution

  • 00854103007196 ()


  • Musculoskeletal/physical therapy laser beam guide, transcutaneous
Legacy Hand Piece 800um Fiber Hand Piece w/ Finger Switch, Dark Gray
LITECURE LLC
PRD-000477-000-02-L
In Commercial Distribution

  • 00854103007172 ()


  • Musculoskeletal/physical therapy laser beam guide, transcutaneous
Legacy Hand Piece 800um Fiber Hand Piece w/ Finger Switch, Cool Gray
LITECURE LLC
PRD-000477-000-01-L
In Commercial Distribution

  • 00854103007165 ()


  • Musculoskeletal/physical therapy laser beam guide, transcutaneous
Smart Hand Piece (SHP)_800um Fiber Assy v2
LITECURE LLC
PRD-000758-010-00-L
In Commercial Distribution

  • 00854103007134 ()


  • Musculoskeletal/physical therapy laser beam guide, transcutaneous
Basic Hand Piece (BHP)_600um Fiber Assy (White)
LITECURE LLC
PRD-000424-010-01-L
In Commercial Distribution

  • 00854103007110 ()


  • Musculoskeletal/physical therapy laser beam guide, transcutaneous
Legacy Hand Piece 600um Fiber Hand Piece w/ Finger Switch, Cool Gray
LITECURE LLC
PRD-000477-000-03-L
In Commercial Distribution

  • 00854103007189 ()


  • Musculoskeletal/physical therapy laser beam guide, transcutaneous
Trade-In 800um SHP v2 Assy LightForce - less than 5 yrs old
DJO, LLC
PRD-000758-010-00-L-L5
In Commercial Distribution

  • 00190446897910 ()


  • Musculoskeletal/physical therapy laser beam guide, transcutaneous
Trade-In 800um SHP v2 Assy LightForce - more than 5 yrs old
DJO, LLC
PRD-000758-010-00-L-G5
In Commercial Distribution

  • 00190446897903 ()


  • Musculoskeletal/physical therapy laser beam guide, transcutaneous
Trade-In 600um BHP LightForce - less than 5yrs old
DJO, LLC
PRD-000424-010-01-L-L5
In Commercial Distribution

  • 00190446897859 ()


  • Musculoskeletal/physical therapy laser beam guide, transcutaneous
kit for open surgery: 1x indocyanine Green for injection, USP 25mg vial 1x sterile water for injection, USP 10ml vial 1x1 piece drape art-drp-0-004
Quest Projects B.V.
ART-ICG-0001
In Commercial Distribution

  • 08719324487030 ()


  • Surgical microscope fluorescent angiography system
No Description
Quest Projects B.V.
ART-SYS-0019
In Commercial Distribution

  • 08719324487009 ()
ART-SYS-0019

  • Surgical microscope fluorescent angiography system
Trade-In 600um BHP LightForce - More than 5yrs old
DJO, LLC
PRD-000424-010-01-L-G5
In Commercial Distribution

  • 00190446897842 ()


  • Musculoskeletal/physical therapy laser beam guide, transcutaneous
R-800um SHP v2 Assy Light Force
DJO, LLC
PRD-000758-010-00-L-R
In Commercial Distribution

  • 00190446887195 ()


  • Musculoskeletal/physical therapy laser beam guide, transcutaneous
GLOW800 - Accessory for Leica surgical operating microscope systems
Leica Microsystems (Schweiz) AG
000000000010449156
In Commercial Distribution

  • 07630802402615 ()

  • Device Size Text, specify:


  • Surgical microscope fluorescent angiography system
FLUORESCENCE IMAGING PROCEDURE KIT
INTUITIVE SURGICAL, INC.
950156
In Commercial Distribution

  • 10886874112776 ()
  • 00886874112779 ()


  • Surgical microscope fluorescent angiography system
INTEGUSEAL Microbial Sealant
Avanos Medical, Inc.
33737
Not in Commercial Distribution

  • 10193494337374 ()
  • 00193494337377 ()
  • 20193494337371 ()

  • Area/Surface Area: 1250 Square centimeter
33737

  • Surgical skin microbial sealant
INTEGUSEAL Microbial Sealant
Avanos Medical, Inc.
33736
Not in Commercial Distribution

  • 20193494337364 ()
  • 10193494337367 ()
  • 00193494337360 ()

  • Area/Surface Area: 625 Square centimeter
33736

  • Surgical skin microbial sealant
IS200
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITED
33737
In Commercial Distribution

  • 05036912001625 ()
  • 05036912001632 ()
  • 05036912001649 ()


  • Surgical skin microbial sealant
IS100
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITED
33736
In Commercial Distribution

  • 05036912001595 ()
  • 05036912001601 ()
  • 05036912001618 ()


  • Surgical skin microbial sealant
FloraSeal Microbial Sealant
ADHEZION BIOMEDICAL, LLC
FS250D
In Commercial Distribution

  • M495FS250D1 ()
  • M495FS250D0 ()

  • Total Volume: 2.5 Milliliter
FS-250D

  • Surgical skin microbial sealant
FloraSeal Mini Microbial Sealant
ADHEZION BIOMEDICAL, LLC
FS035T
In Commercial Distribution

  • M495FS035T0 ()
  • M495FS035T1 ()

  • Total Volume: .35 Milliliter
FS-035T

  • Surgical skin microbial sealant
HALYARD* INTEGUSEAL* Microbial Sealant IS 200
Avanos Medical, Inc.
33737
In Commercial Distribution

  • 20680651337379 ()
  • 10680651337372 ()
  • 30680651337376 ()
33737-01

  • Surgical skin microbial sealant
HALYARD* INTEGUSEAL* Microbial Sealant IS 100
Avanos Medical, Inc.
33736
In Commercial Distribution

  • 30680651337369 ()
  • 20680651337362 ()
  • 10680651337365 ()
33736-01

  • Surgical skin microbial sealant
UIBC Reagent 2 X 66 mL + 2 X 1 mL + 1 X 44 mL
INFRARED LABORATORY SYSTEMS LLC
IR150-1200
In Commercial Distribution

  • 05060500091965 ()
IR150-1200

  • Unsaturated iron binding capacity (UIBC) IVD, reagent
Triglycerides Reagent 8 X 67 mL + 8 wedges
INFRARED LABORATORY SYSTEMS LLC
IR140-1200
In Commercial Distribution

  • 05060500091958 ()
IR140-1200

  • Glucose/ketone/lipid profile IVD, reagent
Total Protein Reagent 6 X 67 mL + 3 X 67 mL
INFRARED LABORATORY SYSTEMS LLC
VI530-1200
In Commercial Distribution

  • 05060500091941 ()
VI530-1200

  • Total protein IVD, reagent
Phosphorus Reagent 2 X 67 mL + 1 X 54 mL
INFRARED LABORATORY SYSTEMS LLC
IR110-1200
In Commercial Distribution

  • 05060500091934 ()
IR110-1200

  • Inorganic phosphate (PO43-) IVD, reagent
Magnesium Reagent 4 X 67 mL
INFRARED LABORATORY SYSTEMS LLC
IR170-1200
In Commercial Distribution

  • 05060500091927 ()
IR170-1200

  • Magnesium (Mg2+) IVD, reagent
LDH Reagent 2 X 67 mL + 1 X 54 mL
INFRARED LABORATORY SYSTEMS LLC
UV340-1200
In Commercial Distribution

  • 05060500091910 ()
UV340-1200

  • Total lactate dehydrogenase (LDH) IVD, reagent
Serum Iron Reagent 2 X 67 mL + 1 X 44 mL
INFRARED LABORATORY SYSTEMS LLC
IR320-1200
In Commercial Distribution

  • 05060500091903 ()
IR320-1200

  • Iron IVD, reagent
Glucose Reagent 6 X 67 mL + 3 X 54 mL
INFRARED LABORATORY SYSTEMS LLC
IR070-1200
In Commercial Distribution

  • 05060500091897 ()
IR070-1200

  • Glucose IVD, reagent
GGT Reagent 3 X 67 mL + 3 wedges
INFRARED LABORATORY SYSTEMS LLC
VI410-1200
In Commercial Distribution

  • 05060500091880 ()
VI410-1200

  • Gamma-glutamyltransferase (GGT) IVD, reagent
Creatinine Reagent 4 X 67 mL + 4 X 67 mL
INFRARED LABORATORY SYSTEMS LLC
VI560-1200
In Commercial Distribution

  • 05060500091873 ()
VI560-1200

  • Creatinine IVD, reagent
Creatine Kinase Reagent 2 X 60 mL + 1 X 60 mL + 3 wedges
INFRARED LABORATORY SYSTEMS LLC
UV310-1200
In Commercial Distribution

  • 05060500091866 ()
UV310-1200

  • Total creatine kinase (CK) IVD, reagent
Cholesterol Reagent 6 X 67 mL + 3 X 54 mL
INFRARED LABORATORY SYSTEMS LLC
IR060-1200
In Commercial Distribution

  • 05060500091859 ()
IR060-1200

  • Total cholesterol lipid IVD, reagent
Calcium Reagent 8 X 67 mL
INFRARED LABORATORY SYSTEMS LLC
IR240-1200
In Commercial Distribution

  • 05060500091835 ()
IR240-1200

  • Calcium (Ca2+) IVD, reagent
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