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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Ocean Ergo XL Dir. Lock
INVACARE CORPORATION
1603080
In Commercial Distribution

  • 04028698132564 ()

  • 1
1603080, 1603157

  • Shower seat, non-powered
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
Bird & Cronin, LLC
08142747
In Commercial Distribution

  • 00610570103645 ()


  • 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
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
Adaptive classroom desk
RIFTON EQUIPMENT
R240
In Commercial Distribution

  • 00850001752473 ()


  • Ergonomic workdesk, manual
No Description
BLEEP, LLC
100605
In Commercial Distribution

  • 10850003157099 ()
  • 00850003157092 ()


  • Home CPAP unit
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
5844-17
In Commercial Distribution

  • 00842430104374 ()
  • 00842430111860 ()
5844-17

  • Medical equipment/instrument drape, single-use
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
Dynarex Corporation
10308
In Commercial Distribution

  • 00616784030814 ()


  • Parallel bar exerciser, non-powered
No Description
Ventana Medical Systems, Inc.
05251583001
In Commercial Distribution

  • 07613336125533 ()
05251583001

  • Assay container IVD, 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
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
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.
26433-FRU
In Commercial Distribution

  • 00813830026177 ()
26433-FRU

  • Medical gas pipeline system
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.
33017-1
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
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
Bird & Cronin, LLC
90002664
In Commercial Distribution

  • 50610570078283 ()
  • 00610570078288 ()


  • Knee sling
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-184-264-000
In Commercial Distribution

  • 00810052863931 ()
00-184-264-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-384-037-000
In Commercial Distribution

  • 00810052863849 ()
00-384-037-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-384-260-000
In Commercial Distribution

  • 00810052863726 ()
00-384-260-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-184-260-000
In Commercial Distribution

  • 00810052863672 ()
00-184-260-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-384-213-000
In Commercial Distribution

  • 00810052863221 ()
00-384-213-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-009-001
In Commercial Distribution

  • 00810052863146 ()
00-284-009-001

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-384-215-000
In Commercial Distribution

  • 00810052862774 ()
00-384-215-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-384-214-000
In Commercial Distribution

  • 00810052862767 ()
00-384-214-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-384-038-000
In Commercial Distribution

  • 00810052862736 ()
00-384-038-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-184-047-000
In Commercial Distribution

  • 00810052862521 ()
00-184-047-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-384-273-000
In Commercial Distribution

  • 00810052864662 ()
00-384-273-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-384-252-000
In Commercial Distribution

  • 00810052864587 ()
00-384-252-000

  • General-purpose centrifuge IVD
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