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 THIN FOAM REGULAR PAD w/ WINGS SCENTED 30 CT
MEIJER, INC.
4703023
In Commercial Distribution

  • 10719283754902 ()
  • 00719283754905 ()
  • 00071928375495 ()


  • Menstrual pad, scented
MULTI PACK SCENTED PLASTIC APPLICATOR TAMPONS
MEIJER, INC.
ME13612SA
In Commercial Distribution

  • 00719283200112 ()
  • 00071928320011 ()
  • 10719283200119 ()


  • Menstrual tampon, scented
MULTI PACK SCENTED PLASTIC APPLICATOR TAMPONS
MEIJER, INC.
ME63606SA
In Commercial Distribution

  • 00719283200075 ()
  • 00071928320007 ()
  • 10719283200072 ()


  • Menstrual tampon, scented
Mouthpiece, TruFit, Soft Flange, Blue, Vanilla Scent, Disposable
Medi/Nuclear Corporation, Inc.
MN2550B
In Commercial Distribution

  • 00857863007895 ()
  • 00857863007857 ()


  • Breathing mouthpiece, single-use
No Description
KMART HOLDING CORPORATION
BKMSGP36
In Commercial Distribution

  • 10883967418364 ()
  • 00883967418367 ()
  • 07290016625172 ()

  • Absorbency


  • Menstrual tampon, scented
No Description
KMART HOLDING CORPORATION
BKMSGS18
In Commercial Distribution

  • 10883967382252 ()
  • 00883967382255 ()
  • 07290016625165 ()

  • Absorbency


  • Menstrual tampon, scented
No Description
KMART HOLDING CORPORATION
BKMSGR18
In Commercial Distribution

  • 10883967382245 ()
  • 00883967382248 ()
  • 07290016625158 ()

  • Absorbency


  • Menstrual tampon, scented
Start your communication journey with a LITTLEmack speech device. With a press of the colored top, an individual can communicate a single message up to 2-minutes long. New messages are easily and quickly recorded to the LITTLEmack on the fly throughout the day to provide opportunities to communicate in almost any scenario. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labs Common Uses Request like "I want" or "I need help" Participate in an activity with "turn the page" or "It's your turn" Tell your classmates what you did over the weekend during a morning meeting Add communication to a switch controlled toy or applianceg Features Better than ever digital sound output suitable for almost any environment Includes red, yellow, green, and blue colored tops Clear snap cover to attach picture symbols and provide communication context to the user Soft-touch coating makes the device easier to hold Symbol Overlays Symbol overlays are not included with the LITTLEmack. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000042
In Commercial Distribution

  • 00850011150078 ()
10000042

  • Assistive speech generator
Start your communication journey with a BIGmack speech device. With a press of the large colored top, an individual can communicate a single message up to 2-minutes long. New messages are easily and quickly recorded to the BIGmack on the fly throughout the day to provide opportunities to communicate in almost any scenario. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labs Common Uses Request like "I want" or "I need help" Participate in an activity with "turn the page" or "It's your turn" Tell your classmates what you did over the weekend during a morning meeting Add communication to a switch controlled toy or applianceg Features Better than ever digital sound output suitable for almost any environment Includes red, yellow, green, and blue colored tops Clear snap cover to attach picture symbols and provide communication context to the user Soft-touch coating makes the device easier to hold Symbol Overlays Symbol overlays are not included with the BIGmack. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000041
In Commercial Distribution

  • 00850011150061 ()
10000041

  • Uncarboxylated matrix Gla protein (ucMGP) IVD, kit, chemiluminescent immunoassay
SCEW GUIDE
MEDTRONIC SOFAMOR DANEK, INC.
X0300019
In Commercial Distribution

  • 00673978995656 ()


  • General internal orthopaedic fixation system implantation kit
The Defender Room Air Cleaner ("Defender") is a portable, mechanical air filtration system designed for single use int he home environment. It is configured as a circular unit with a protective outer housing, a pleated fiberglass filter that exceeds HEPA filters in both efficiency and particulate size, and an oxygen activated charcoal filter (HEGA) to remove gasses and odors. During operation, air is drawn into the lower assembly, passes through the upper assembly providing a 360-degree flow of air. The unit is equipped with a scent generator powered by a small heating element. Outlet filtered air passes through the scent generator and out from the top of the unit. The Defender is intended to filter indoor air to remove micro-particles as small as 0.1 micron in size. Including dust, pollen, smoke, dust mites allergens, cockroach allergens, bacteria, mold and pet allergens. The Defender is also intended to remove Tobacco smoke and other household odors.
Health Mor At Home Cbp
D11NA
In Commercial Distribution

  • 00863342000318 ()


  • High-efficiency filter air cleaner, mobile
Every Cycle reusable tampon applicator
Cycle LLC
7000
In Commercial Distribution

  • 00860007113727 ()


  • Menstrual tampon, unscented
  • Menstrual tampon, scented
Bubble gum scented disposable anesthesia face mask
Ambu A/S
K1122
In Commercial Distribution

  • 00612649182865 ()
  • 00612649204154 ()
  • 05707480132355 ()

  • 2
  • Size 1
K1122

  • Anaesthesia face mask, single-use
MESH 9352515 25MM ENDCAP 15 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9352515
Not in Commercial Distribution

  • 00613994218872 ()

  • 25mm


  • Polymeric spinal interbody fusion cage
MESH 9352504 25MM ENDCAP 4 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9352504
Not in Commercial Distribution

  • 00613994218858 ()

  • 25mm


  • Polymeric spinal interbody fusion cage
MESH 9352500 25MM ENDCAP 0 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9352500
In Commercial Distribution

  • 00613994218841 ()

  • 25mm


  • Polymeric spinal interbody fusion cage
MESH 9352215 22MM ENDCAP 15 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9352215
Not in Commercial Distribution

  • 00613994218834 ()

  • 22mm


  • Polymeric spinal interbody fusion cage
MESH 9352208 22MM ENDCAP 8 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9352208
Not in Commercial Distribution

  • 00613994218827 ()

  • 22mm


  • Polymeric spinal interbody fusion cage
MESH 9352204 22MM ENDCAP 4 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9352204
In Commercial Distribution

  • 00613994218810 ()

  • 22mm


  • Polymeric spinal interbody fusion cage
MESH 9352200 22MM ENDCAP 0 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9352200
In Commercial Distribution

  • 00613994218803 ()

  • 22mm


  • Polymeric spinal interbody fusion cage
MESH 9351915 19MM ENDCAP 15 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9351915
Not in Commercial Distribution

  • 00613994218797 ()

  • 19mm


  • Polymeric spinal interbody fusion cage
MESH 9351908 19MM ENDCAP 8 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9351908
Not in Commercial Distribution

  • 00613994218780 ()

  • 19mm


  • Polymeric spinal interbody fusion cage
MESH 9351904 19MM ENDCAP 4 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9351904
Not in Commercial Distribution

  • 00613994218773 ()

  • 19mm


  • Polymeric spinal interbody fusion cage
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
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-311
In Commercial Distribution

  • 18859751213110 ()
  • 08859751213113 ()


  • 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-212
In Commercial Distribution

  • 18859751212120 ()
  • 08859751212123 ()


  • Orbital rim prosthesis
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-312
In Commercial Distribution

  • 18859751213127 ()
  • 08859751213120 ()


  • 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-211
In Commercial Distribution

  • 18859751212113 ()
  • 08859751212116 ()


  • Orbital rim prosthesis
AquariusWeb Viewer (aka AqWeb or Web Viewer, marketing term) is a version of iNtuitionEMV with a focus on 3D rendering, additionally providing workflow and scene support.
Terarecon Inc.
Aquarius Web
In Commercial Distribution

  • INTUITION6 ()


  • Radiological PACS software
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