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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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Dental porcelain/ceramic restoration kit
ARGEN CORPORATION, THE
119283
In Commercial Distribution

  • D818119283 ()
119283

  • Dental porcelain/ceramic restoration kit
Dental porcelain/ceramic restoration kit
ARGEN CORPORATION, THE
119282
In Commercial Distribution

  • D818119282 ()
119282

  • Dental porcelain/ceramic restoration kit
Dental porcelain/ceramic restoration kit
ARGEN CORPORATION, THE
119281
In Commercial Distribution

  • D818119281 ()
119281

  • Dental porcelain/ceramic restoration kit
Dental porcelain/ceramic restoration kit
ARGEN CORPORATION, THE
119280
In Commercial Distribution

  • D818119280 ()
119280

  • Dental porcelain/ceramic restoration kit
Dental porcelain/ceramic restoration kit
ARGEN CORPORATION, THE
119246
In Commercial Distribution

  • D818119246 ()
119246

  • Dental porcelain/ceramic restoration kit
Gold based noble metal
ARGEN CORPORATION, THE
119114
In Commercial Distribution

  • D818119114 ()
119114

  • Dental casting noble alloy
Gold based noble metal
ARGEN CORPORATION, THE
119113
In Commercial Distribution

  • D818119113 ()
119113

  • Dental casting noble alloy
Gold based noble metal
ARGEN CORPORATION, THE
119112
In Commercial Distribution

  • D818119112 ()
119112

  • Dental casting noble alloy
Gold based noble metal
ARGEN CORPORATION, THE
115809
In Commercial Distribution

  • D818115809 ()
115809

  • Dental casting noble alloy
Gold based noble metal
ARGEN CORPORATION, THE
115807
In Commercial Distribution

  • D818115807 ()
115807

  • Dental casting noble alloy
Gold based noble metal
ARGEN CORPORATION, THE
115806
In Commercial Distribution

  • D818115806 ()
115806

  • Dental casting noble alloy
Gold based noble metal
ARGEN CORPORATION, THE
115805
In Commercial Distribution

  • D818115805 ()
115805

  • Dental casting noble alloy
Gold based noble metal
ARGEN CORPORATION, THE
115777
In Commercial Distribution

  • D818115777 ()
115777

  • Dental casting noble alloy
Base metal alloy
ARGEN CORPORATION, THE
100437
In Commercial Distribution

  • D818100437 ()
100437

  • Dental casting non-noble alloy
No Description
SALVIN DENTAL SPECIALTIES, LLC
PT-5
In Commercial Distribution

  • 00841336103740 ()


  • Bone lever/elevator, reusable
No Description
MAUNA KEA TECHNOLOGIES
FP-10036
In Commercial Distribution

  • 03760187912080 ()


  • Confocal endomicroscopy system probe
No Description
MAUNA KEA TECHNOLOGIES
211-0149
In Commercial Distribution

  • 03760187910260 ()
MP-0014-HCEL

  • Confocal endomicroscopy system probe
temporary cement, non eugenol
bisico Bielefelder Dentalsilicone GmbH & Co. KG
03710
In Commercial Distribution

  • EBIB037101 ()
03710

  • Zinc polycarboxylate dental cement
No Description
Roche Diagnostics GmbH
4373391190
In Commercial Distribution

  • 04015630920983 ()
4373391190

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.
LUMINEX CORPORATION
3806
In Commercial Distribution

  • 00840487100127 ()
3806

  • Endogenous RNA internal control reagent IVD
No Description
BIOTRONIK SE & Co. KG
402658
Not in Commercial Distribution

  • 04035479140137 ()
402658

  • Cardiac resynchronization therapy implantable defibrillator
No Description
BIOTRONIK SE & Co. KG
393055
Not in Commercial Distribution

  • 04035479129705 ()
393055

  • Single-chamber implantable defibrillator
No Description
BIOTRONIK SE & Co. KG
393049
Not in Commercial Distribution

  • 04035479129644 ()
393049

  • Single-chamber implantable defibrillator
No Description
BIOTRONIK SE & Co. KG
383596
Not in Commercial Distribution

  • 04035479125523 ()
383596

  • Single-chamber implantable defibrillator
No Description
BIOTRONIK SE & Co. KG
383584
Not in Commercial Distribution

  • 04035479125400 ()
383584

  • Single-chamber implantable defibrillator
No Description
BIOTRONIK SE & Co. KG
383568
Not in Commercial Distribution

  • 04035479125240 ()
383568

  • Dual-chamber implantable defibrillator
No Description
SEBIA
4759
In Commercial Distribution

  • 03607360047590 ()
4759

  • Haemoglobin detection IVD, control
Compatible with 2.7mm/3.5mm screws, implants for orthopedic bone fixation
FLOWER ORTHOPEDICS CORPORATION
FRP 905
In Commercial Distribution

  • 00840118103473 ()

  • Height: 3.2 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable
Compatible with 2.7mm/3.5mm screws, implants for orthopedic bone fixation
FLOWER ORTHOPEDICS CORPORATION
FRP 705
In Commercial Distribution

  • 00840118103374 ()

  • Height: 2.5 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable
Compatible with 1.5mm/2.0mm/2.4mm screws, implants for orthopedic bone fixation
FLOWER ORTHOPEDICS CORPORATION
FMP 211
In Commercial Distribution

  • 00840118102957 ()

  • Height: 1.5 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable
Compatible with 2.7mm/3.5mm screws, implants for orthopedic bone fixation
FLOWER ORTHOPEDICS CORPORATION
FRP 930
In Commercial Distribution

  • 00840118101042 ()

  • Height: 3.7 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable
5 VIALS
SEBIA
4795
In Commercial Distribution

  • 03607360047958 ()
4795

  • Carbohydrate deficient transferrin IVD, control
No Description
SEBIA
4781
In Commercial Distribution

  • 03607360047811 ()
4781

  • Protein electrophoresis IVD, control
Qtest 5 (25 pack) - AMP 1000, COC 300, MET 1000, OPI 2000,THC 50
MEDIMPEX UNITED, INC
QT-CUP
In Commercial Distribution

  • 10864040000317 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
RESPONDER 5, ENHANCED, GETWELL
CURBELL MEDICAL PRODUCTS, INC.
4C412U-001020F
In Commercial Distribution

  • 00840828156226 ()
21386

  • Pillow speaker
RESPONDER 5, ENHANCED, GETWELL
CURBELL MEDICAL PRODUCTS, INC.
4C410U-701033F
In Commercial Distribution

  • 00840828156219 ()
21385

  • Pillow speaker
No Description
HYPHEN BIOMED
221205
In Commercial Distribution

  • 03663537008238 ()
221205

  • Protein C IVD, kit, chromogenic
No Description
AMI Agency for Medical Innovations GmbH
EIR1530
Not in Commercial Distribution

  • EAMIEIR15300 ()

  • Shaft Length: 420 Millimeter
  • Outer Diameter: 5 Millimeter
EIR1530

  • Electrosurgical handpiece, reusable
No Description
AMI Agency for Medical Innovations GmbH
EIR1520
Not in Commercial Distribution

  • EAMIEIR15200 ()

  • Shaft Length: 340 Millimeter
  • Outer Diameter: 5 Millimeter
EIR1520

  • Electrosurgical handpiece, reusable
No Description
AMI Agency for Medical Innovations GmbH
EIR1510
Not in Commercial Distribution

  • EAMIEIR15100 ()

  • Shaft Length: 250 Millimeter
  • Outer Diameter: 5 Millimeter
EIR1510

  • Electrosurgical handpiece, reusable
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