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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BluEX-A (24 X 32 X 26 mm, 30°)
L&K BIOMED CO. ,LTD.
BA2432-2630S
In Commercial Distribution

  • 08809986465917 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 23 mm, 30°)
L&K BIOMED CO. ,LTD.
BA2432-2330S
In Commercial Distribution

  • 08809986465900 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 20 mm, 30°)
L&K BIOMED CO. ,LTD.
BA2432-2030S
In Commercial Distribution

  • 08809986465894 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 17 mm, 30°)
L&K BIOMED CO. ,LTD.
BA2432-1730S
In Commercial Distribution

  • 08809986465887 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 21 mm, 25°)
L&K BIOMED CO. ,LTD.
BA2432-2125S
In Commercial Distribution

  • 08809986465863 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 18 mm, 25°)
L&K BIOMED CO. ,LTD.
BA2432-1825S
In Commercial Distribution

  • 08809986465856 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 15 mm, 25°)
L&K BIOMED CO. ,LTD.
BA2432-1525S
In Commercial Distribution

  • 08809986465849 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 22 mm, 20°)
L&K BIOMED CO. ,LTD.
BA2432-2220S
In Commercial Distribution

  • 08809986465832 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 19 mm, 20°)
L&K BIOMED CO. ,LTD.
BA2432-1920S
In Commercial Distribution

  • 08809986465825 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 16 mm, 20°)
L&K BIOMED CO. ,LTD.
BA2432-1620S
In Commercial Distribution

  • 08809986465818 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 13 mm, 20°)
L&K BIOMED CO. ,LTD.
BA2432-1320S
In Commercial Distribution

  • 08809986465801 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 19 mm, 15°)
L&K BIOMED CO. ,LTD.
BA2432-1915S
In Commercial Distribution

  • 08809986465795 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 16 mm, 15°)
L&K BIOMED CO. ,LTD.
BA2432-1615S
In Commercial Distribution

  • 08809986465788 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 13 mm, 15°)
L&K BIOMED CO. ,LTD.
BA2432-1315S
In Commercial Distribution

  • 08809986465771 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 10 mm, 15°)
L&K BIOMED CO. ,LTD.
BA2432-1015S
In Commercial Distribution

  • 08809986465764 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 18 mm, 12°)
L&K BIOMED CO. ,LTD.
BA2432-1812S
In Commercial Distribution

  • 08809986465757 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 15 mm, 12°)
L&K BIOMED CO. ,LTD.
BA2432-1512S
In Commercial Distribution

  • 08809986465740 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 12 mm, 12°)
L&K BIOMED CO. ,LTD.
BA2432-1212S
In Commercial Distribution

  • 08809986465733 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 16 mm, 8°)
L&K BIOMED CO. ,LTD.
BA2432-1608S
In Commercial Distribution

  • 08809986465726 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 13 mm, 8°)
L&K BIOMED CO. ,LTD.
BA2432-1308S
In Commercial Distribution

  • 08809986465719 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 10 mm, 8°)
L&K BIOMED CO. ,LTD.
BA2432-1008S
In Commercial Distribution

  • 08809986465702 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 07 mm, 0°)
L&K BIOMED CO. ,LTD.
BA2432-0700S
In Commercial Distribution

  • 08809986465696 ()


  • Metallic spinal interbody fusion cage
2.0 NX Extremity Nail 24 mm 1/pkg
FIELD ORTHOPAEDICS PTY LTD
APN000192
In Commercial Distribution

  • 09353903009139 ()
NXNC-2024/1

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Thyreoglobulin - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381638
In Commercial Distribution

  • 00630414972077 ()
LKTY1(D)

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
Thyroglobulin CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388175
In Commercial Distribution

  • 00630414979472 ()
LTYCVM

  • Thyroglobulin antibody IVD, control
Positioning premature infants is a major challenge in intensive care. Newborn babies in general, but especially premature babies, are less active and often lie in one position. As a result, certain body parts are exposed to increased pressure. As the bones of the skull are still very soft in the first months of life, the head is sensitive to permanent pressure. This is particularly critical for premature babies, as the skull is still softer due to the low maturity at birth. Premature babies often have to be monitored in the hospital for several months and also have to stay in an incubator. Head deformations, such as plagiocephaly, brachycephaly and dolichocephaly, are often the result of unilateral positioning of premature and newborn babies on their sides or backs. In studies, the incidence of head deformations in premature babies is reported to be up to 90 %. With the Medibino Neo positioning system, we provide a solution for pressure-relieving positioning and stabilisation of the mid-head position of premature babies and infants during long hospital stays.
Kluba Medical GmbH
1
In Commercial Distribution

  • 04260764840724 ()
  • 04260764840571 ()

  • Fits for premature infants weighting 200-800g
24021703-S

  • Infant recumbent sleep positioner
Positioning premature infants is a major challenge in intensive care. Newborn babies in general, but especially premature babies, are less active and often lie in one position. As a result, certain body parts are exposed to increased pressure. As the bones of the skull are still very soft in the first months of life, the head is sensitive to permanent pressure. This is particularly critical for premature babies, as the skull is still softer due to the low maturity at birth. Premature babies often have to be monitored in the hospital for several months and also have to stay in an incubator. Head deformations, such as plagiocephaly, brachycephaly and dolichocephaly, are often the result of unilateral positioning of premature and newborn babies on their sides or backs. In studies, the incidence of head deformations in premature babies is reported to be up to 90 %. With the Medibino Neo positioning system, we provide a solution for pressure-relieving positioning and stabilisation of the mid-head position of premature babies and infants during long hospital stays.
Kluba Medical GmbH
1
In Commercial Distribution

  • 04260764840564 ()
  • 04260764840717 ()

  • Fits for premature infants weighting 800-2000g
24021703-M

  • Infant recumbent sleep positioner
KILT BLOCKER SET - Standard Size with Hook and Loop Closure, .25mm Xenolite 800 NL Size S8T, 18"L X 20"W, 20"L X 24"W, 24"L X 24"W
BURLINGTON MEDICAL, LLC
U8KILTBLOCKERS8T
In Commercial Distribution

  • 00840331272857 ()


  • Radiation shielding apron
KILT BLOCKER SET - Standard Size with Hook and Loop Closure, .35mm Xenolite 800 NL Size S8T, 18"L X 20"W, 20"L X 24"W, 24"L X 24"W
BURLINGTON MEDICAL, LLC
S8KILTBLOCKERS8T
In Commercial Distribution

  • 00840331272796 ()


  • Radiation shielding apron
KILT BLOCKER SET - Standard Size with Hook and Loop Closure, .5mm Xenolite 800 NL Size S8T, 18"L X 20"W, 20"L X 24"W, 24"L X 24"W
BURLINGTON MEDICAL, LLC
R8KILTBLOCKERS8T
In Commercial Distribution

  • 00840331272734 ()


  • Radiation shielding apron
Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
287363246
In Commercial Distribution

  • 09421028118460 ()
287363246

  • Orthopaedic inorganic implant inserter/extractor, reusable
Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
287363244
In Commercial Distribution

  • 09421028118446 ()
287363244

  • Orthopaedic inorganic implant inserter/extractor, reusable
Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
LET20224T
In Commercial Distribution

  • 09421028118385 ()
LET20224T

  • Orthopaedic inorganic implant inserter/extractor, reusable
Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
LET30324T
In Commercial Distribution

  • 09421028118361 ()
LET30324T

  • Orthopaedic inorganic implant inserter/extractor, reusable
No Description
Bird & Cronin, LLC
08142747
In Commercial Distribution

  • 00610570103645 ()


  • Knee sling
No Description
Bird & Cronin, LLC
08142664
In Commercial Distribution

  • 00610570010509 ()


  • Knee sling
No Description
Bird & Cronin, LLC
08142658
In Commercial Distribution

  • 00610570010448 ()


  • Knee sling
No Description
Bird & Cronin, LLC
08142654
In Commercial Distribution

  • 00610570010400 ()


  • Knee sling
BOJRAB DISSECTOR, LARGE, ANGLED 24° 2.1MM X 1.8MM STAINLESS STEEL
Grace Medical, Inc.
999-DB1
In Commercial Distribution

  • 00844505013697 ()


  • Open-surgery dissector
No Description
Dynarex Corporation
10308
In Commercial Distribution

  • 00616784030814 ()


  • Parallel bar exerciser, non-powered
No Description
BLEEP, LLC
100605
In Commercial Distribution

  • 10850003157099 ()
  • 00850003157092 ()


  • Home CPAP unit
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-009-001
Not in Commercial Distribution

  • 00858092006864 ()
00-284-009-001

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
01-389-109-000VK
In Commercial Distribution

  • 00858092006772 ()
01-389-109-000VK

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
01-389-109-000K
In Commercial Distribution

  • 00858092006765 ()
01-389-109-000K

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-389-129-001K
In Commercial Distribution

  • 00858092006758 ()
00-389-129-001K

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-389-129-000K
In Commercial Distribution

  • 00858092006741 ()
00-389-129-000K

  • General-purpose centrifuge IVD
MRI Coil
Siemens Shenzhen Magnetic Resonance Ltd.
10837354
In Commercial Distribution

  • 04056869015521 ()


  • Full-body MRI system, superconducting magnet
No Description
CELL MARQUE CORPORATION
312M-18
In Commercial Distribution

  • 00841683134985 ()


  • B-cell specific activator protein (BSAP) IVD, antibody
No Description
CELL MARQUE CORPORATION
312M-17
In Commercial Distribution

  • 00841683134978 ()


  • B-cell specific activator protein (BSAP) IVD, antibody
No Description
CELL MARQUE CORPORATION
312M-16
In Commercial Distribution

  • 00841683134961 ()


  • B-cell specific activator protein (BSAP) IVD, antibody
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