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
Laborie Medical Technologies Canada ULC
PRO839
In Commercial Distribution

  • 00627825004534 ()


  • Urodynamic measurement system
No Description
Biomet Orthopedics, LLC
904754
In Commercial Distribution

  • 00880304464858 ()
904754

  • Tendon/ligament bone anchor, non-bioabsorbable
No Description
Biomet Sports Medicine, LLC
909848
In Commercial Distribution

  • 00880304464773 ()
909848

  • Ligament reconstruction instrument set, reusable
No Description
Biomet Orthopedics, LLC
904756
In Commercial Distribution

  • 00880304464223 ()
904756

  • Tendon/ligament bone anchor, non-bioabsorbable
No Description
Biomet Orthopedics, LLC
904755
In Commercial Distribution

  • 00880304453364 ()
904755

  • Tendon/ligament bone anchor, non-bioabsorbable
No Description
Biomet Sports Medicine, LLC
110017308
In Commercial Distribution

  • 00880304676947 ()

  • 2.9 MM
110017308

  • Tendon/ligament bone anchor, non-bioabsorbable
No Description
Biomet Orthopedics, LLC
110010384
In Commercial Distribution

  • 00880304676930 ()

  • 2.9 MM
110010384

  • Tendon/ligament bone anchor, non-bioabsorbable
No Description
Biomet Sports Medicine, LLC
909874
In Commercial Distribution

  • 00880304478923 ()

  • 4.5 MM
909874

  • Ligament bone anchor
Artemis along with the Needle Guide Attachment is used for image-guided interventional and diagnostic procedures of the prostate gland. It provides 2D and 3D visualization of Ultrasound (US) images and the ability to fuse and register these images with those from other imaging modalities such as Ultrasound, Magnetic Resonance, Computed Tomography, etc. It also provides the ability to display a simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target organ and the current and the projected future path of the interventional instrument taking into account patient movement. The software also provides a virtual grid on the live ultrasound for performing systematic sampling of the target organ. Other software features include patient data management, multi-planar reconstruction, segmentation, image measurements, 2D/3D image registration, reporting, and pathology management. Artemis is intended for treatment planning and guidance for clinical, interventional and/or diagnostic procedures. The device is intended to be used in interventional and diagnostic procedures in a clinical setting. Example procedures include, but are not limited to image fusion for diagnostic clinical examinations and procedures, soft tissue biopsies, soft tissue ablations and placement of fiducial markers. Artemis is also intended to be used for patients in active surveillance to keep track of previous procedures information and outcomes.
Eigen Health Services LLC
2.0 HD
In Commercial Distribution

  • 00860009734838 ()


  • Rectal ultrasound navigational image processor
Power muscle stimulator with Electrodes
Emsi
FLEMC0001
In Commercial Distribution

  • 00859718007289 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
  • Transcutaneous electrical stimulation electrode, single-use
Rectosigmoidoscope with obturator, compatible with Storz Light Source for 20R3 / 9052
Bk Medical ApS
UA0673
In Commercial Distribution

  • 05704916001360 ()


  • Rigid endoscope obturator
Rectosigmoidoscope with obturator, compatible with Welch Allyn Light Source for 20R3 / 9052
Bk Medical ApS
UA0672
In Commercial Distribution

  • 05704916001353 ()


  • Rigid endoscope obturator
Silver Coverlet with Zipper
KREG MEDICAL INC.
ASM100118
In Commercial Distribution

  • 00850520008211 ()


  • Waterproof bed mattress cover, reusable
  • Antimicrobial bed mattress cover
Deep Purple Coverlet with Zipper
KREG MEDICAL INC.
ASM100117
In Commercial Distribution

  • 00850520008204 ()


  • Waterproof bed mattress cover, reusable
  • Antimicrobial bed mattress cover
Ambu® Military Perfit ACE™ and Ambu® Military Head Wedge™, Adult
Ambu A/S
000281153
In Commercial Distribution

  • 05707480038626 ()
  • 05707480038619 ()

  • Adult
000281153

  • Cervical spine collar, single-use
Ambu® Perfit ACE™ and Ambu® Head Wedge™, Adult
Ambu A/S
000281152
In Commercial Distribution

  • 05707480037308 ()
  • 05707480037315 ()

  • Adult
000281152

  • Cervical spine collar, single-use
Ambu® Perfit ACE™ and Ambu® Head Wedge™, Adult
Ambu A/S
000281151
In Commercial Distribution

  • 05707480006540 ()
  • 05707480024667 ()

  • Adult
000281151

  • Cervical spine collar, single-use
Ambu® Mini Perfit ACE™ and Ambu® Head Wedge™, Small Pediatric and Pediatric
Ambu A/S
000281161
In Commercial Distribution

  • 05707480006557 ()
  • 05707480024674 ()

  • Mini
000281161

  • Cervical spine collar, single-use
No Description
Biomet Sports Medicine, LLC
909849
In Commercial Distribution

  • 00880304472709 ()
909849

  • Ligament reconstruction instrument set, reusable
No Description
Biomet Orthopedics, LLC
909854
In Commercial Distribution

  • 00880304470361 ()

  • 4.5 MM
909854

  • Ligament reconstruction instrument set, reusable
No Description
Biomet Orthopedics, LLC
904753
In Commercial Distribution

  • 00880304469471 ()

  • 4.5 MM
904753

  • Tendon/ligament bone anchor, non-bioabsorbable
Play With Me - Double Play - Dual Vibrating Cock Ring - Purple Part Number:BL-77101 Material Type: TPE-ABS
Blush Novelties
Play With Me - Double Play - Dual Vibrating Cock Ring - Purple
In Commercial Distribution

  • 00853858007956 ()
BL-77101

  • Penile ring
Play With Me - King of the Ring Part Number:BL-93652 Material Type: TPE
Blush Novelties
Play With Me - King of the Ring
In Commercial Distribution

  • 00853858007628 ()
BL-93652

  • Penile ring
Play With Me - Stretch C-Ring - 50 pieces Part Number: BC-009 Material Type: TPE
Blush Novelties
Play With Me - Stretch C-Ring - 50 pieces
In Commercial Distribution

  • 00853858007611 ()
BC-009

  • Penile ring
Play With Me - Lick It - Vibrating Double Strap Cock Ring - Purple Part Number: BL-61911 Material Type: TPE
Blush Novelties
Play With Me - Lick It - Vibrating Double Strap Cock Ring - Purple
In Commercial Distribution

  • 00853858007598 ()
BL-61911

  • Penile ring
No Description
Z-Medical GmbH + Co. KG
A16 374
In Commercial Distribution

  • 04057217005867 ()


  • Surgical instrument handle, non-torque-limiting
FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining.
BIO SB, INC.
1000 ml
In Commercial Distribution

  • B502BSB01680 ()
BSB 0168

  • DAPI solution IVD
FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining.
BIO SB, INC.
500 ml
In Commercial Distribution

  • B502BSB01670 ()
BSB 0167

  • DAPI solution IVD
FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining.
BIO SB, INC.
200 ml
In Commercial Distribution

  • B502BSB01660 ()
BSB 0166

  • DAPI solution IVD
FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining.
BIO SB, INC.
100 ml
In Commercial Distribution

  • B502BSB01650 ()
BSB 0165

  • DAPI solution IVD
FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining.
BIO SB, INC.
50 ml
In Commercial Distribution

  • B502BSB01640 ()
BSB 0164

  • DAPI solution IVD
FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining.
BIO SB, INC.
15 ml
In Commercial Distribution

  • B502BSB01630 ()
BSB 0163

  • DAPI solution IVD
Hayrake-Palatal with Spurs
ALLESEE AOA-PRO
3000-0073
In Commercial Distribution

  • 00889989083545 ()


  • Orthodontic habit prevention/breaking appliance, bonded
The Nephros SSU-D is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.).
NEPHROS, INC.
70-0243O
Not in Commercial Distribution

  • 10896241002500 ()
  • 00896241002503 ()


  • Microbial water purification filter, non-sterilizable
The Nephros SSU-D is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.).
NEPHROS, INC.
70-0243O
Not in Commercial Distribution

  • 10896241002517 ()
  • 00896241002510 ()
  • 20896241002514 ()


  • Microbial water purification filter, non-sterilizable
The VORTRAN®-IPPB allows for single-patient use of an airway clearance device. It provides high aerosol output with a large nebulizer reservoir. It is easily set-up and more cost effective than a conventional IPPB machine. It is excellent for patients with fluid retention in the lungs.
VORTRAN MEDICAL TECHNOLOGY 1, INC
IPM-4022
In Commercial Distribution

  • 20637320040221 ()
  • 10637320040224 ()
IPM-4022

  • Ultrasonic nebulizing system
No Description
Octostop Inc
FI-01A
In Commercial Distribution

  • B525FI01A0 ()


  • X-ray/radiation therapy beam filter, wedge
Adhesive Bandages, scary designs, 3/4 IN x 3 IN (19 mm x 76 mm)
Aso LLC
017276238822
In Commercial Distribution

  • 60017276238824 ()
  • 00017276238822 ()


  • Skin-cover adhesive strip, non-antimicrobial
The MRIaudio PREM system with MRIview is an MRI conditional audio and video solution that provides MRI patients with music, visual entertainment, direct communication, and hearing protection.
MRIAUDIO, INC.
3501
In Commercial Distribution

  • B66935011 ()
3501

  • Patient audiovisual communication/entertainment system
The MRIaudio PREM system with MRIview is an MRI conditional audio and video solution that provides MRI patients with music, visual entertainment, direct communication, and hearing protection.
MRIAUDIO, INC.
3500
In Commercial Distribution

  • B66935001 ()
3500

  • Patient audiovisual communication/entertainment system
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