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
BLEEP, LLC
100605
In Commercial Distribution

  • 10850003157099 ()
  • 00850003157092 ()


  • Home CPAP unit
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
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
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
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
No Description
CELL MARQUE CORPORATION
312M-15
In Commercial Distribution

  • 00841683134954 ()


  • B-cell specific activator protein (BSAP) IVD, antibody
No Description
CELL MARQUE CORPORATION
312M-14
In Commercial Distribution

  • 00841683134916 ()


  • B-cell specific activator protein (BSAP) IVD, antibody
MRI Coil
Siemens Shenzhen Magnetic Resonance Ltd.
10837354
In Commercial Distribution

  • 04056869015521 ()


  • Full-body MRI system, superconducting magnet
Neurofeedback headbox
DEYMED Diagnostic s.r.o.
43-139
In Commercial Distribution

  • 08592566431395 ()
43-139

  • Psychophysiological biofeedback system
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
Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
REDAX SPA
10526
In Commercial Distribution

  • 18034139296606 ()
  • 08034139296609 ()
10526

  • Closed-wound drain connector
This device is a sterile and single-use. This product has the proximal end flute-lipped for a easier insertion. Each catheter is provided with a radiopaque line to allow radiographic visualization. Depth markings, made with silicone points, must be found to a predefined distance as per technical specification from the beginning of the draining part that corresponds to the last punching hole in order to ease the positioning and removal of the catheter itself.
REDAX SPA
21824
In Commercial Distribution

  • 18034139293780 ()
  • 08034139293783 ()
21824

  • Pleural catheter
This device is a sterile and single-use. This product has the proximal end flute-lipped for a easier insertion. Each catheter is provided with a radiopaque line to allow radiographic visualization. Depth markings, made with silicone points, must be found to a predefined distance as per technical specification from the beginning of the draining part that corresponds to the last punching hole in order to ease the positioning and removal of the catheter itself.
REDAX SPA
20824
In Commercial Distribution

  • 18034139292844 ()
  • 08034139292847 ()
20824

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

  • 04028698132564 ()

  • 1
1603080, 1603157

  • Shower seat, non-powered
Hematocrit rotor, 24-place
Andreas Hettich GmbH & Co. KG
1650-A
In Commercial Distribution

  • 04050674077675 ()
1650-A

  • Microhaematocrit centrifuge IVD
No Description
RPI
LSU002
In Commercial Distribution

  • 00841034114703 ()
LSU002

  • Electrocardiographic lead set, reusable
No Description
RPI
LSR002
In Commercial Distribution

  • 00841034114666 ()
LSR002

  • Electrocardiographic lead set, reusable
No Description
RPI
LSN002
In Commercial Distribution

  • 00841034114628 ()
LSN002

  • Electrocardiographic lead set, reusable
No Description
RPI
LSG002
In Commercial Distribution

  • 00841034114581 ()
LSG002

  • Electrocardiographic lead set, reusable
No Description
RPI
LSE002
In Commercial Distribution

  • 00841034114567 ()
LSE002

  • Electrocardiographic lead set, reusable
No Description
RPI
LSB002
In Commercial Distribution

  • 00841034114529 ()
LSB002

  • Electrocardiographic lead set, reusable
No Description
RPI
LPW002
In Commercial Distribution

  • 00841034114482 ()
LPW002

  • Electrocardiographic lead set, reusable
No Description
RPI
LPU002
In Commercial Distribution

  • 00841034114468 ()
LPU002

  • Electrocardiographic lead set, reusable
No Description
RPI
LPR002
In Commercial Distribution

  • 00841034114420 ()
LPR002

  • Electrocardiographic lead set, reusable
No Description
RPI
LPB002
In Commercial Distribution

  • 00841034114284 ()
LPB002

  • Electrocardiographic lead set, reusable
No Description
RPI
LSW002
In Commercial Distribution

  • 00841034114727 ()
LSW002

  • Electrocardiographic lead set, reusable
No Description
RPI
LPN002
In Commercial Distribution

  • 00841034114383 ()
LPN002

  • Electrocardiographic lead set, reusable
No Description
RPI
LPG002
In Commercial Distribution

  • 00841034114345 ()
LPG002

  • Electrocardiographic lead set, reusable
No Description
RPI
LPE002
In Commercial Distribution

  • 00841034114321 ()
LPE002

  • Electrocardiographic lead set, reusable
No Description
Eckert & Ziegler BEBIG GmbH
LAH02-24#03
Not in Commercial Distribution

  • 04049223106621 ()
LAH02-24

  • General-purpose brachytherapy system applicator, remote-afterloading
Hematocrit rotor, 24-place
Andreas Hettich GmbH & Co. KG
1650
In Commercial Distribution

  • 04050674030441 ()
1650

  • Microhaematocrit centrifuge IVD
Hematocrit rotor, 24-place
Andreas Hettich GmbH & Co. KG
1023
In Commercial Distribution

  • 04050674030427 ()
1023

  • Microhaematocrit centrifuge IVD
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
Dynarex Corporation
10308
In Commercial Distribution

  • 00616784030814 ()


  • Parallel bar exerciser, non-powered
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
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