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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Ultra Concentrated Enzymatic Evacuation Cleaner and Instrument Pre-Soak With the Deodorizing Power of Baking Soda. Orange Scented; Dual Enzymes; Non-Corrosive; Non-Foaming; Biodegradable; Non-Toxic; Makes 35 gallons of cleaner. 300g Pouch
PASCAL COMPANY, INC.
15250
In Commercial Distribution

  • 00310866000015 ()
15250

  • Medical device cleaning agent
Extended Tab Scerw Persuader
GS Medical Co., Ltd.
GS114-0760
In Commercial Distribution

  • 08806395498079 ()
GS114-0760

  • Orthopaedic counter-torque/rod-pushing instrument
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11589501
In Commercial Distribution

  • 04068151009477 ()


  • PET system application software
  • SPECT system application software
Scepter XC
MICROVENTION INC.
BC0411XC-ID-700-AL
In Commercial Distribution

  • 00842429117583 ()

  • 4.0 mm x 11 mm
BC0411XC

  • Intravascular occluding balloon catheter, image-guided
Scepter C
MICROVENTION INC.
BC0420C-ID-700-AL
In Commercial Distribution

  • 00842429117569 ()

  • 4.0 mm x 20 mm
BC0420C

  • Intravascular occluding balloon catheter, image-guided
Scepter C
MICROVENTION INC.
BC0415C-ID-700-AL
In Commercial Distribution

  • 00842429117552 ()

  • 4.0 mm x 15 mm
BC0415C

  • Intravascular occluding balloon catheter, image-guided
Scepter C
MICROVENTION INC.
BC0410C-ID-700-AL
In Commercial Distribution

  • 00842429117545 ()

  • 4.0 mm x 10 mm
BC0410C

  • Intravascular occluding balloon catheter, image-guided
Module Assay SCE FACSLyric US IVD
Becton, Dickinson And Company
665006
In Commercial Distribution

  • 00382906650061 ()
665006

  • White blood cell count IVD, kit, cell count
The METICULY Patient-specific titanium maxillofacial mesh implant is a device designed individually for each patient and intended for use in selective trauma of the maxillofacial skeleton, maxillofacial surgery, and reconstructive procedures. It is specifically designed with a focus on applications of non-bending related scenarios. The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion) and is intended to be used with titanium screws. All additive manufacturing and other post processing steps are only to take place under Meticuly manufacturing control. The device is not intended to substitute for bone reconstruction in clinical situations where bone is needed for support and stability of the maxillofacial skeleton under functional loading conditions. It is intended for adults only (at least 22 years of age). The surgeon approves the design of the mesh implant prior to fabrication of the implant device by the sponsor. The proposed FaciMesh models are intended to treat the maxillofacial region, while the OrbiMesh models treat the Orbital region. The device is not intended for reconstruction of the orbital roof defects or for any frontal bone defects, such as the supra-orbital ridge. Additionally, the FDA-cleared commercially available titanium screws that can be used with the subject devices include the TITANIUM MINIPLATE SYSTEM (K951690) and MICRO TITANIUM PLATE SYSTEM (K951688).
METICULY COMPANY LIMITED
MF-314
In Commercial Distribution

  • 18859751213141 ()
  • 08859751213144 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
The METICULY Patient-specific titanium maxillofacial mesh implant is a device designed individually for each patient and intended for use in selective trauma of the maxillofacial skeleton, maxillofacial surgery, and reconstructive procedures. It is specifically designed with a focus on applications of non-bending related scenarios. The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion) and is intended to be used with titanium screws. All additive manufacturing and other post processing steps are only to take place under Meticuly manufacturing control. The device is not intended to substitute for bone reconstruction in clinical situations where bone is needed for support and stability of the maxillofacial skeleton under functional loading conditions. It is intended for adults only (at least 22 years of age). The surgeon approves the design of the mesh implant prior to fabrication of the implant device by the sponsor. The proposed FaciMesh models are intended to treat the maxillofacial region, while the OrbiMesh models treat the Orbital region. The device is not intended for reconstruction of the orbital roof defects or for any frontal bone defects, such as the supra-orbital ridge. Additionally, the FDA-cleared commercially available titanium screws that can be used with the subject devices include the TITANIUM MINIPLATE SYSTEM (K951690) and MICRO TITANIUM PLATE SYSTEM (K951688).
METICULY COMPANY LIMITED
MF-313
In Commercial Distribution

  • 18859751213134 ()
  • 08859751213137 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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