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
SALVIN DENTAL SPECIALTIES, LLC
PT-5
In Commercial Distribution

  • 00841336103740 ()


  • Bone lever/elevator, reusable
No Description
BIOMET MICROFIXATION, INC
91-6804-5PK
Not in Commercial Distribution

  • 00841036190408 ()
91-6804-5PK

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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
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
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
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
ergoline GmbH
191002.T
Not in Commercial Distribution

  • 04059358001630 ()


  • Bicycle ergometer
No Description
ergoline GmbH
191002.P
Not in Commercial Distribution

  • 04059358001623 ()


  • Bicycle ergometer
No Description
ergoline GmbH
191002
In Commercial Distribution

  • 04059358001616 ()


  • Bicycle ergometer
No Description
BIOCARE MEDICAL LLC
ACI3025C
In Commercial Distribution

  • 00847627002693 ()


  • Cytokeratin IVD, antibody
No Description
BIOCARE MEDICAL LLC
ACI3025A
In Commercial Distribution

  • 00847627002686 ()


  • Cytokeratin IVD, antibody
Twist Drill, 5/16”
SYMMETRY MEDICAL INC.
11-001-400
In Commercial Distribution

  • 00847538007961 ()
2709-01-015;00-9986-010-26;430032

  • Fluted surgical drill bit, reusable
No Description
BIOCARE MEDICAL LLC
API3025AA
In Commercial Distribution

  • 00847627003959 ()


  • Cytokeratin IVD, antibody
The Global Reference Module 5 provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.
NEURALYNX, INC.
Global Reference Module - 5
In Commercial Distribution

  • 00850011306550 ()
31-0604-0047

  • Electroencephalographic signal amplifier
No Description
QUINTRON INSTRUMENT COMPANY, INC.
QT01140-K
In Commercial Distribution

  • 00850010197869 ()
  • 00850010197234 ()
QT01140-K

  • Gas chromatography analyser IVD
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
1600386-001
In Commercial Distribution

  • J00716003860011 ()
1600386-001

  • Dental power tool system handpiece, remotely-driven
Classroom chair
RIFTON EQUIPMENT
R350
In Commercial Distribution

  • 00850001752206 ()


  • Assistive ergonomic chair, manually-adjusted
SET of different CA & HP supplied for students.
Bien-Air Dental SA
1700794-001
In Commercial Distribution

  • J00717007941001 ()
1700794-001

  • Dental power tool system handpiece, remotely-driven
No Description
LUCERNO DYNAMICS, LLC
D
In Commercial Distribution

  • 00850014578213 ()
  • 00850014578053 ()
401874-220-5

  • Scintillation-counter radiation survey meter
Absorbent gelling fibrous dressing
SMITH & NEPHEW MEDICAL LIMITED
66800563
In Commercial Distribution

  • 05000223467036 ()
  • 05000223466787 ()
  • 05000223467043 ()
66800563

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Multi-Diluent 5 Atellica IM - CONS (2 PK) 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995647
Not in Commercial Distribution

  • 00630414599656 ()
  • 00630414007724 ()
10995647

  • Buffered sample diluent IVD
Absorbent gelling fibrous dressing
SMITH & NEPHEW MEDICAL LIMITED
66800561
In Commercial Distribution

  • 05000223466978 ()
  • 05000223466725 ()
  • 05000223466985 ()
66800561

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
No Description
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
LG1620
In Commercial Distribution

  • 00848657075749 ()
LG1620

  • Laparoscopic surgical procedure kit, non-medicated, reusable
No Description
Cochlear Bone Anchored Solutions AB
95470
In Commercial Distribution

  • 09321502034586 ()
95470

  • Bone-conduction hearing implant system sound processor/vibrator
No Description
Cochlear Bone Anchored Solutions AB
95224
In Commercial Distribution

  • 09321502032803 ()
95224

  • Bone-conduction hearing implant system sound processor/vibrator
No Description
Cochlear Bone Anchored Solutions AB
95207
In Commercial Distribution

  • 09321502028721 ()
95207

  • Bone-conduction hearing implant system sound processor/vibrator
No Description
Cochlear Bone Anchored Solutions AB
95474
In Commercial Distribution

  • 09321502034623 ()
95474

  • Bone-conduction hearing implant system sound processor/vibrator
No Description
Cochlear Bone Anchored Solutions AB
95473
In Commercial Distribution

  • 09321502034616 ()
95473

  • Bone-conduction hearing implant system sound processor/vibrator
No Description
Cochlear Bone Anchored Solutions AB
95472
In Commercial Distribution

  • 09321502034609 ()
95472

  • Bone-conduction hearing implant system sound processor/vibrator
No Description
Cochlear Bone Anchored Solutions AB
95471
In Commercial Distribution

  • 09321502034593 ()
95471

  • Bone-conduction hearing implant system sound processor/vibrator
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-15-0352
In Commercial Distribution

  • 09348215074159 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-15-0270
In Commercial Distribution

  • 09348215073695 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-201-505
In Commercial Distribution

  • 09348215073534 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-102-218
In Commercial Distribution

  • 09348215056704 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-102-160
In Commercial Distribution

  • 09348215056575 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-102-080
In Commercial Distribution

  • 09348215056377 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-28-0097
In Commercial Distribution

  • 09348215051280 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
WAXING INSTRUMENT #5 GRAY
HAGER WORLDWIDE, INC.
304055
Not in Commercial Distribution

  • D24830405510 ()


  • Dental restoration carver, multiple-material
WAXING INSTRUMENT #5 GRAY
HAGER WORLDWIDE, INC.
304055
In Commercial Distribution

  • D2483040550 ()


  • Dental restoration carver, multiple-material
Chrome-plated air/water syringe
HAGER WORLDWIDE, INC.
BOA124P1000
In Commercial Distribution

  • D248B16280 ()
  • D248BOA124P10001 ()


  • Dental delivery system irrigation handpiece tip
Wire Clip-On Loupe (+5) Eyewear
HAGER WORLDWIDE, INC.
87048
In Commercial Distribution

  • D2488704809 ()


  • Eye splash shield, reusable
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