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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Device Name: CERASORB® M DENTAL lndications for Use: CERASORB® M DENTAL is recommended for: - Augmentation or reconstructive treatment of the alveolar ridge - Filling of infrabony periodontal defects - Filling of defects after root resection, apicoectomy and cystectomy - Filling of extraction sockets to enhance preservation of the alveolar ridge - Elevation of the maxillary sinus floor - Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) - Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
curasan AG
500-1000µm
In Commercial Distribution

  • ECURS05V0500 ()

  • Total Volume: 0.5 Centiliter
1 x 0.5 cc

  • Dental bone matrix implant, synthetic
Device Name: CERASORB® M DENTAL lndications for Use: CERASORB® M DENTAL is recommended for: - Augmentation or reconstructive treatment of the alveolar ridge - Filling of infrabony periodontal defects - Filling of defects after root resection, apicoectomy and cystectomy - Filling of extraction sockets to enhance preservation of the alveolar ridge - Elevation of the maxillary sinus floor - Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) - Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
curasan AG
500-1000µm
In Commercial Distribution

  • ECURS05M0500 ()
  • ECURS05M05005 ()

  • Total Volume: 0.5 Centiliter
5 x 0.5 cc

  • Dental bone matrix implant, synthetic
No Description
TEKNIMED
T060415
In Commercial Distribution

  • 03760177042117 ()
T060415

  • Orthopaedic cement preparation/delivery kit
No Description
Advanced Bionics, LLC
CI-5826
In Commercial Distribution



  • Electrical-only medical device connection cable, reusable
Left 2
Advanced Bionics, LLC
CI-5851-009
In Commercial Distribution



  • Cochlear implant/auditory brainstem implant sound processor speaker
Left 1
Advanced Bionics, LLC
CI-5851-008
In Commercial Distribution



  • Cochlear implant/auditory brainstem implant sound processor speaker
Left 0
Advanced Bionics, LLC
CI-5851-007
In Commercial Distribution



  • Cochlear implant/auditory brainstem implant sound processor speaker
Left 00
Advanced Bionics, LLC
CI-5851-006
In Commercial Distribution



  • Cochlear implant/auditory brainstem implant sound processor speaker
Right 3
Advanced Bionics, LLC
CI-5851-005
In Commercial Distribution



  • Cochlear implant/auditory brainstem implant sound processor speaker
Right 2
Advanced Bionics, LLC
CI-5851-004
In Commercial Distribution



  • Cochlear implant/auditory brainstem implant sound processor speaker
Right 1
Advanced Bionics, LLC
CI-5851-003
In Commercial Distribution



  • Cochlear implant/auditory brainstem implant sound processor speaker
Right 0
Advanced Bionics, LLC
CI-5851-002
In Commercial Distribution



  • Cochlear implant/auditory brainstem implant sound processor speaker
Right 00
Advanced Bionics, LLC
CI-5851-001
In Commercial Distribution



  • Cochlear implant/auditory brainstem implant sound processor speaker
Large
Advanced Bionics, LLC
CI-5837-300
In Commercial Distribution



  • Cochlear implant/auditory brainstem implant sound processor
Small
Advanced Bionics, LLC
CI-5837-100
In Commercial Distribution



  • Cochlear implant/auditory brainstem implant sound processor
No Description
Advanced Bionics, LLC
CI-5068
In Commercial Distribution



  • Secondary battery
No Description
Advanced Bionics, LLC
CI-5607
In Commercial Distribution



  • Noninvasive device battery charger
Velvet Black
Advanced Bionics, LLC
CI-5555-150
In Commercial Distribution



  • Secondary battery
Silver Gray
Advanced Bionics, LLC
CI-5555-140
In Commercial Distribution



  • Secondary battery
Chestnut
Advanced Bionics, LLC
CI-5555-130
In Commercial Distribution



  • Secondary battery
Sand Beige
Advanced Bionics, LLC
CI-5555-120
In Commercial Distribution



  • Secondary battery
Left 3
Advanced Bionics, LLC
CI-5851-010
In Commercial Distribution



  • Cochlear implant/auditory brainstem implant sound processor speaker
Medium
Advanced Bionics, LLC
CI-5837-200
In Commercial Distribution



  • Cochlear implant/auditory brainstem implant sound processor
Omni
Advanced Bionics, LLC
CI-5607
In Commercial Distribution

  • 00840094433977 ()


  • Noninvasive device battery charger
Resin Beige
Advanced Bionics, LLC
CI-5555-240
In Commercial Distribution



  • Secondary battery
Majesty purple
Advanced Bionics, LLC
CI-5555-270
In Commercial Distribution



  • Secondary battery
Precious pink
Advanced Bionics, LLC
CI-5555-250
In Commercial Distribution



  • Secondary battery
Caribbean pirate
Advanced Bionics, LLC
CI-5555-190
In Commercial Distribution



  • Secondary battery
Blue ocean
Advanced Bionics, LLC
CI-5555-260
In Commercial Distribution



  • Secondary battery
Breastboard with head support and Monarch™ Overhead Arm Positioner
MEDTEC, INC.
MTM410
Not in Commercial Distribution

  • 00841439113455 ()
MTM410

  • Radiological breast positioner, non-wearable
Breastboard with head support and Monarch™ Overhead Arm Positioner
MEDTEC, INC.
MTM400
In Commercial Distribution

  • 00841439110287 ()
MTM400

  • Radiological breast positioner, non-wearable
Device Name: CERASORB® M DENTAL lndications for Use: CERASORB® M DENTAL is recommended for: - Augmentation or reconstructive treatment of the alveolar ridge - Filling of infrabony periodontal defects - Filling of defects after root resection, apicoectomy and cystectomy - Filling of extraction sockets to enhance preservation of the alveolar ridge - Elevation of the maxillary sinus floor - Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) - Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
curasan AG
500-1000µm
In Commercial Distribution

  • ECURS20M0500 ()
  • ECUS20M05005 ()

  • Total Volume: 2.0 Centiliter
5 x 2.0 cc

  • Dental bone matrix implant, synthetic
Device Name: CERASORB® M DENTAL lndications for Use: CERASORB® M DENTAL is recommended for: - Augmentation or reconstructive treatment of the alveolar ridge - Filling of infrabony periodontal defects - Filling of defects after root resection, apicoectomy and cystectomy - Filling of extraction sockets to enhance preservation of the alveolar ridge - Elevation of the maxillary sinus floor - Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) - Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
curasan AG
500-1000µm
In Commercial Distribution

  • ECURS10V0500 ()

  • Total Volume: 1.0 Centiliter
1 x 1.0 cc

  • Dental bone matrix implant, synthetic
Device Name: CERASORB® M DENTAL lndications for Use: CERASORB® M DENTAL is recommended for: - Augmentation or reconstructive treatment of the alveolar ridge - Filling of infrabony periodontal defects - Filling of defects after root resection, apicoectomy and cystectomy - Filling of extraction sockets to enhance preservation of the alveolar ridge - Elevation of the maxillary sinus floor - Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) - Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
curasan AG
500-1000µm
In Commercial Distribution

  • ECURS10M0500 ()
  • ECURS10M05005 ()

  • Total Volume: 1.0 Centiliter
5 x 1.0 cc

  • Dental bone matrix implant, synthetic
Device Name: CERASORB® M DENTAL lndications for Use: CERASORB® M DENTAL is recommended for: - Augmentation or reconstructive treatment of the alveolar ridge - Filling of infrabony periodontal defects - Filling of defects after root resection, apicoectomy and cystectomy - Filling of extraction sockets to enhance preservation of the alveolar ridge - Elevation of the maxillary sinus floor - Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) - Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
curasan AG
1000-2000µm
In Commercial Distribution

  • ECURS05M1000 ()
  • ECURS05M10005 ()

  • Total Volume: 0.5 Centiliter
5 x 0.5 cc

  • Dental bone matrix implant, synthetic
Device Name: CERASORB® M DENTAL lndications for Use: CERASORB® M DENTAL is recommended for: - Augmentation or reconstructive treatment of the alveolar ridge - Filling of infrabony periodontal defects - Filling of defects after root resection, apicoectomy and cystectomy - Filling of extraction sockets to enhance preservation of the alveolar ridge - Elevation of the maxillary sinus floor - Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) - Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
curasan AG
150-500µm
In Commercial Distribution

  • ECURS05M0150 ()
  • ECURS05M01505 ()

  • Total Volume: 0.5 Centiliter
5 x 0.5 cc

  • Dental bone matrix implant, synthetic
No Description
SORIN GROUP ITALIA SRL
SYNTHESIS
In Commercial Distribution

  • 38033178109254 ()
  • 08033178109253 ()


  • Extracorporeal membrane oxygenator
EXCIA M PLASMAPORE-µCAP 8/10 SIZE 18MM
Aesculap AG
NC818T
Not in Commercial Distribution

  • 04046963469719 ()

  • CCD angle (°) : 135
  • Implant Fixation : cementless
  • Taper Size : 8/10
  • Figure/Size : Size 18
NC818T

  • Coated hip femur prosthesis, modular
EXCIA M PLASMAPORE-µCAP 8/10 SIZE 17MM
Aesculap AG
NC817T
Not in Commercial Distribution

  • 04046963469702 ()

  • Figure / Size : Size 17
  • Implant Fixation : cementless
  • CCD angle (°) : 135
  • Taper Size : 8/10
NC817T

  • Coated hip femur prosthesis, modular
EXCIA M PLASMAPORE-µCAP 8/10 SIZE 16MM
Aesculap AG
NC816T
Not in Commercial Distribution

  • 04046963469696 ()

  • Implant Fixation : cementless
  • Taper Size : 8/10
  • CCD angle (°) : 135
  • Figure/Size : Size 16
NC816T

  • Coated hip femur prosthesis, modular
EXCIA M PLASMAPORE-µCAP 8/10 SIZE 15MM
Aesculap AG
NC815T
Not in Commercial Distribution

  • 04046963469689 ()

  • CCD angle (°) : 135
  • Implant Fixation : cementless
  • Taper Size : 8/10
  • Figure / Size : Size 15
NC815T

  • Coated hip femur prosthesis, modular
EXCIA M PLASMAPORE-µCAP 8/10 SIZE 14MM
Aesculap AG
NC814T
Not in Commercial Distribution

  • 04046963469672 ()

  • CCD angle (°) : 135
  • Taper Size : 8/10
  • Figure / Size : Size 14
  • Implant Fixation : cementless
NC814T

  • Coated hip femur prosthesis, modular
EXCIA M PLASMAPORE-µCAP 8/10 SIZE 13MM
Aesculap AG
NC813T
Not in Commercial Distribution

  • 04046963469665 ()

  • Implant Fixation : cementless
  • Figure / Size : Size 13
  • Taper Size : 8/10
  • CCD angle (°) : 135
NC813T

  • Coated hip femur prosthesis, modular
EXCIA M PLASMAPORE-µCAP 8/10 SIZE 12MM
Aesculap AG
NC812T
Not in Commercial Distribution

  • 04046963469658 ()

  • Figure / Size : Size 12
  • CCD angle (°) : 135
  • Implant Fixation : cementless
  • Taper Size : 8/10
NC812T

  • Coated hip femur prosthesis, modular
EXCIA M PLASMAPORE-µCAP 8/10 SIZE 11MM
Aesculap AG
NC811T
Not in Commercial Distribution

  • 04046963469641 ()

  • Implant Fixation : cementless
  • Taper Size : 8/10
  • CCD angle (°) : 135
  • Figure / Size : Size 11
NC811T

  • Coated hip femur prosthesis, modular
EXCIA M PLASMAPORE-µCAP 8/10 SIZE 10MM
Aesculap AG
NC810T
Not in Commercial Distribution

  • 04046963469634 ()

  • Figure / Size : Size 10
  • Implant Fixation : cementless
  • Taper Size : 8/10
  • CCD angle (°) : 135
NC810T

  • Coated hip femur prosthesis, modular
EXCIA M PLASMAPORE-µCAP 8/10 SIZE 9MM
Aesculap AG
NC809T
Not in Commercial Distribution

  • 04046963469627 ()

  • Taper Size : 8/10
  • Implant Fixation : cementless
  • Figure / Size : Size 9
  • CCD angle (°) : 135
NC809T

  • Coated hip femur prosthesis, modular
EXCIA M PLASMAPORE-µCAP 8/10 SIZE 8MM
Aesculap AG
NC808T
Not in Commercial Distribution

  • 04046963469610 ()

  • CCD angle (°) : 135
  • Taper Size : 8/10
  • Figure / Size : Size 8
  • Implant Fixation : cementless
NC808T

  • Coated hip femur prosthesis, modular
TLIF,FREER ELEVATOR,DOUBLE ENDED,190MM
Choice Spine, LP
P070-6124
In Commercial Distribution

  • 00840996192491 ()


  • Metallic spinal interbody fusion cage
The PRO M CLASS is an AC-powered device that includes a "Motor Handpiece","Contra angle Handpiece","Charger unit" and "AC/DC Adaptor" for grinding, cutting, polishing and screw driver work in dental oral use.
SAEYANG MICROTECH CO.,LTD
PRO M CLASS
In Commercial Distribution

  • 08809394971352 ()


  • Dental surgical power tool motor, electric
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