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
Dynarex Corporation
10308
In Commercial Distribution

  • 00616784030814 ()


  • Parallel bar exerciser, non-powered
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
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
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
08142747
In Commercial Distribution

  • 00610570103645 ()


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

  • 00610570010400 ()


  • Knee sling
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
Made with Tempur-Pedic® Medical materials.
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69453
In Commercial Distribution

  • 00842430100673 ()
69453

  • Operating table mattress, basic
Made with Tempur-Pedic® Medical materials.
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69452
In Commercial Distribution

  • 00842430100666 ()
69452

  • Operating table mattress, basic
Made with Tempur-Pedic® Medical materials.
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69444
In Commercial Distribution

  • 00842430100659 ()
69444

  • Operating table mattress, basic
Made with Tempur-Pedic® Medical materials.
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69442
In Commercial Distribution

  • 00842430100604 ()
69442

  • Operating table mattress, basic
No Description
Axiodent Inc.
28019
In Commercial Distribution

  • D161280190 ()


  • Denture trial fabrication wax
This is a medical device.
KaVo Dental GmbH
0.571.5621
In Commercial Distribution

  • EKAV057156210 ()
rootplaner Tip No 24

  • Ultrasonic dental scaling/debridement system
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
5844-17
In Commercial Distribution

  • 00842430104374 ()
  • 00842430111860 ()
5844-17

  • Medical equipment/instrument drape, single-use
A sterile, semi-rigid tube used in open heart surgery to facilitate the transfer of priming fluids during the priming of the extracorporeal circuit of a cardiopulmonary bypass system. It is a noninvasive product in the form of a tube or tubing used to channel the fluids (i.e., primer/blood) to facilitate priming of the extracorporeal circuit and connection of the cardiopulmonary bypass system (heart/lung machine) to the patient. It is typically a moulded plastic tube with hard plastic spike at the distal end that connects to the bag or container of primer solution, a connector at the proximal end, and a central pinch clamp. This is a single-use device.
NOVOSCI CORP.
301124-000
In Commercial Distribution

  • B0663011240000 ()
  • B0663011240006 ()
301124-000

  • Cardiopulmonary bypass system priming set
Neurofeedback headbox
DEYMED Diagnostic s.r.o.
43-139
In Commercial Distribution

  • 08592566431395 ()
43-139

  • Psychophysiological biofeedback system
PureCeption 24 - Determination Bi-Layer Kit. 6x12 mL each of 40% UPPER and 80% LOWER Phase In HEPES-buffered HTF
Origio A/S
ART-2024
In Commercial Distribution

  • 60888937818583 ()


  • IVF medium kit
Ocean Ergo XL Dir. Lock
INVACARE CORPORATION
1603080
In Commercial Distribution

  • 04028698132564 ()

  • 1
1603080, 1603157

  • Shower seat, non-powered
No Description
ACCUTRON, INC.
26433-FRU
In Commercial Distribution

  • 00813830026177 ()
26433-FRU

  • Medical gas pipeline system
No Description
ACCUTRON, INC.
33015-9
In Commercial Distribution

  • 00813830025699 ()
33015-9

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33015-16
In Commercial Distribution

  • 00813830025675 ()
33015-16

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33015-15
In Commercial Distribution

  • 00813830025668 ()
33015-15

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33015-14
In Commercial Distribution

  • 00813830025651 ()
33015-14

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
25096-FRU
In Commercial Distribution

  • 00813830026153 ()
25096-FRU

  • Medical gas pipeline system
No Description
ACCUTRON, INC.
33017-9
In Commercial Distribution

  • 00813830025866 ()
33017-9

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33017-17
In Commercial Distribution

  • 00813830025859 ()
33017-17

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33017-12
In Commercial Distribution

  • 00813830025842 ()
33017-12

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33017-11
In Commercial Distribution

  • 00813830025835 ()
33017-11

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33017-10
In Commercial Distribution

  • 00813830025828 ()
33017-10

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33017-1
In Commercial Distribution

  • 00813830025811 ()
33017-1

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33016-9
In Commercial Distribution

  • 00813830025804 ()
33016-9

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33016-16
In Commercial Distribution

  • 00813830025774 ()
33016-16

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33016-15
In Commercial Distribution

  • 00813830025767 ()
33016-15

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33016-14
In Commercial Distribution

  • 00813830025750 ()
33016-14

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33016-12
In Commercial Distribution

  • 00813830025736 ()
33016-12

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33016-11
In Commercial Distribution

  • 00813830025729 ()
33016-11

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33016-10
In Commercial Distribution

  • 00813830025712 ()
33016-10

  • Anaesthesia face mask, single-use
No Description
Dynarex Corporation
36277
In Commercial Distribution

  • 00840117323322 ()
  • 00840117315396 ()
  • 00840117315303 ()


  • Nasopharyngeal airway, single-use
No Description
BIOTECHNOLOGY INSTITUTE SL
DHG24
In Commercial Distribution

  • 08435389801818 ()


  • Surgical screwdriver, reusable
No Description
BIOTECHNOLOGY INSTITUTE SL
DC24
In Commercial Distribution

  • 08435389801795 ()


  • Surgical screwdriver, reusable
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
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