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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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90D lens for BIOM 5
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
53604
In Commercial Distribution

  • 04049584007759 ()


  • Ophthalmic surgical microscope
WFE lens for BIOM 5
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
53602
In Commercial Distribution

  • 04049584007735 ()


  • Ophthalmic surgical microscope
Universal Trial Frame UB 5
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
42550
In Commercial Distribution

  • 04049584005816 ()


  • Trial lens frame
ERA® Standard 5° Female. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
811601
In Commercial Distribution

  • 00841549102189 ()


  • Resilient dental precision attachment
No Description
BIOANALYTIC GmbH, biomed. Analysentechnik
ETE005-0100
In Commercial Distribution

  • 04061609000439 ()
  • 04061609000644 ()


  • Microcapillary blood collection tube IVD, no additive
men, 172 mm long, ID 16 mm OD 29x18.5 mm
Spiggle & Theis Medizintechnik GmbH
50-200-05
In Commercial Distribution

  • 04250381858288 ()
50-200-05

  • Rigid intubation laryngoscope, reusable
No Description
RPI
KEB019
In Commercial Distribution

  • 00841034112464 ()
KEB019

  • Electrocardiographic lead set, reusable
No Description
RPI
KEB018
In Commercial Distribution

  • 00841034112457 ()
KEB018

  • Electrocardiographic lead set, reusable
No Description
RPI
KEB015
In Commercial Distribution

  • 00841034112440 ()
KEB015

  • Electrocardiographic lead set, reusable
No Description
BIOMET MICROFIXATION, INC
75-6414
In Commercial Distribution

  • 00841036123031 ()
75-6414

  • Sternal fixation device
No Description
BIOMET MICROFIXATION, INC
75-6416
In Commercial Distribution

  • 00841036122867 ()
75-6416

  • Sternal fixation device
This pad is designed for use with the 5806 Radiolucent Imaging Top. Dimensions: 58x20x2 inches. Made with Tempur-Pedic® Medical materials
MIZUHO ORTHOPEDIC SYSTEMS, INC.
5806-7010
In Commercial Distribution

  • 00842430101793 ()
5806-7010

  • Operating table mattress, basic
Surgical Instrument Tray
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
33509
In Commercial Distribution

  • 09008737335090 ()


  • Instrument tray, reusable
No Description
Noras MRI products GmbH
01
In Commercial Distribution

  • 04251269200755 ()
112996

  • MRI system coil, radio-frequency
very fine, shaft length 125 mm for use with handle 90-220-00
Spiggle & Theis Medizintechnik GmbH
90-222-05
In Commercial Distribution

  • 04250676719591 ()
90-222-05

  • General/plastic surgery mirror
SILICONE CUSHION MASK SIZE#5
BESMED HEALTH BUSINESS CORP.
SM-86251
In Commercial Distribution

  • 04716770862514 ()


  • Cardiopulmonary resuscitation mask, reusable
Conformity stem, high offset, #5
UNITED ORTHOPEDIC CORP.
1110-3205
In Commercial Distribution

  • 04711605583329 ()
1110-3205

  • Metal-on-polyethylene total hip prosthesis
  • Revision coated hip femur prosthesis
  • Coated hip femur prosthesis, modular
No Description
MICROSURGICAL TECHNOLOGY, INC.
IH-90330
In Commercial Distribution

  • 00844685002696 ()
IH-90330

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
No Description
MICROSURGICAL TECHNOLOGY, INC.
TA-93331
In Commercial Distribution

  • 00844685002689 ()
TA-93331

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
No Description
LIFE TECHNOLOGIES CORPORATION
180267
Not in Commercial Distribution

  • 10190302007993 ()


  • Multiple solid tumour differentiation marker IVD, kit, enzyme immunoassay (EIA)
Multidil 5Readypack (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10309946
Not in Commercial Distribution

  • 00630414175263 ()
  • 00630414003122 ()
110317

  • Buffered sample diluent IVD
No Description
BIOCARE MEDICAL LLC
ALI105G7
In Commercial Distribution

  • 00847627029751 ()


  • Cytokeratin IVD, antibody
Clone R226
NOVODIAX, INC.
K32014-015
Not in Commercial Distribution

  • 00850000596139 ()

  • Total Volume: 15 Milliliter
K32014-015

  • Cytokeratin IVD, kit, enzyme immunohistochemistry
Clone R226
NOVODIAX, INC.
K47014-015
Not in Commercial Distribution

  • 00850000596122 ()

  • Total Volume: 15 Milliliter
K47014-015

  • Cytokeratin IVD, kit, enzyme immunohistochemistry
Clone R226
NOVODIAX, INC.
K47014-010
Not in Commercial Distribution

  • 00850000596115 ()

  • Total Volume: 10 Milliliter
K47014-010

  • Cytokeratin IVD, kit, enzyme immunohistochemistry
Clone R226
NOVODIAX, INC.
K47014-005
Not in Commercial Distribution

  • 00850000596108 ()

  • Total Volume: 5 Milliliter
K47014-005

  • Cytokeratin IVD, kit, enzyme immunohistochemistry
No Description
QUINTRON INSTRUMENT COMPANY, INC.
QT02688
In Commercial Distribution

  • 00850010197876 ()
  • 00850010197272 ()
QT02688

  • Gas chromatography analyser IVD
Rack of 6 - 32 mm length - Diam 1.50 Peeso Reamers are mechanized dental instruments used for accessing to the root canal and enlarging the opening of the coronal part of the root canal, before and after using files. Peeso Reamers are also used for pin or post hole preparation.
Produits dentaires S.A.
20442
In Commercial Distribution

  • J01020442 ()


  • Endodontic enlarger, reusable
Rack of 6 - 32 mm length - Diam 1.30 Gates Glidden are mechanized dental instruments used for accessing to the root canal and enlarging the opening of the coronal part of the root canal, before and after using files. Gates-Glidden are also used for pin or post hole preparation.
Produits dentaires S.A.
20342
In Commercial Distribution

  • J01020342 ()


  • Endodontic enlarger, reusable
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600690-001
In Commercial Distribution

  • J00716006900011 ()
1600690-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1601058-001
In Commercial Distribution

  • J00716010580011 ()
1601058-001

  • Pneumatic dental handpiece coupler
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
3460S-5
In Commercial Distribution

  • 00842430115202 ()
  • 00842430112515 ()
3460S-5

  • Upper-limb traction wrap/trap, reusable
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
3460M-5
In Commercial Distribution

  • 00842430115196 ()
  • 00842430112508 ()
3460M-5

  • Upper-limb traction wrap/trap, reusable
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
3460L-5
In Commercial Distribution

  • 00842430115189 ()
  • 00842430112492 ()
3460L-5

  • Upper-limb traction wrap/trap, reusable
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
1937S
In Commercial Distribution

  • 10842430110112 ()
  • 00842430110115 ()
1937SDZ

  • Freestanding headrest, single-use
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
1941S
In Commercial Distribution

  • 10842430110099 ()
  • 00842430110092 ()
1941SDZ

  • Freestanding headrest, single-use
No Description
Noras MRI products GmbH
02
In Commercial Distribution

  • 04251269205347 ()
112996

  • MRI system coil, radio-frequency
No Description
IT-V Medizintechnik GmbH
P10107-642
In Commercial Distribution

  • 09120074396425 ()


  • Radiological whole-body positioner
No Description
IT-V Medizintechnik GmbH
P10107-483
In Commercial Distribution

  • 09120074394834 ()


  • Radiological whole-body positioner
No Description
Orasure Technologies, Inc.
1154IB
In Commercial Distribution

  • 00608337000726 ()


  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
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