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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
SOC ETUDES RECHERCHES FABRICATION
TE607- 36 CC
In Commercial Distribution

  • 03662200019663 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
SOC ETUDES RECHERCHES FABRICATION
TE607- 32 CC
In Commercial Distribution

  • 03662200019632 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
SOC ETUDES RECHERCHES FABRICATION
TE607- 28 CC
In Commercial Distribution

  • 03662200019601 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
SOC ETUDES RECHERCHES FABRICATION
TE607- 22.2 CC
In Commercial Distribution

  • 03662200019571 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
TEKNIMED
Granules 10 cc
Not in Commercial Distribution

  • 03760177041196 ()

  • Granules
  • Pore Size: 220 Micrometer
  • Weight: 6.3 Gram
03.02.002

  • Bone matrix implant, synthetic, non-antimicrobial
The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or more screws via the screw head and a rod using a force-fit or form-fit connection. Additional fixation elements, such as cross bars, hooks, connectors and washers, can also be used. The DIPLOMAT® pedicle screw system is applied temporarily to provide internal posterior stabilization until bone fusion in the lumbar or thoracic spine has taken place. The surgeon makes the final decision as to the indwelling time of the implant in the patient‘s body and the time when the implant is to be explanted. The pedicle screw system is implanted from a posterior approach. The implant is screwed into the vertebral body via the pedicle and it can be applied in a single segment or multiple segments. Implantation is facilitated by use of the specially developed accessories for inserting and positioning the implants. Only these accessories ensure safe use. Our product information provides further system-related information on the surgical method. If there are any preoperative uncertainties relating to the implant, information must be obtained from SIGNUS. Instruments specially developed by SIGNUS to ensure safe application are available for use with the implant system.
SIGNUS Medizintechnik GmbH
Parallel connector CC
In Commercial Distribution

  • 04047844127377 ()

  • Ø5,5mm/6,0mm
AB0163-55060/S

  • Spinal bone screw, non-bioabsorbable
The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or more screws via the screw head and a rod using a force-fit or form-fit connection. Additional fixation elements, such as cross bars, hooks, connectors and washers, can also be used. The DIPLOMAT® pedicle screw system is applied temporarily to provide internal posterior stabilization until bone fusion in the lumbar or thoracic spine has taken place. The surgeon makes the final decision as to the indwelling time of the implant in the patient‘s body and the time when the implant is to be explanted. The pedicle screw system is implanted from a posterior approach. The implant is screwed into the vertebral body via the pedicle and it can be applied in a single segment or multiple segments. Implantation is facilitated by use of the specially developed accessories for inserting and positioning the implants. Only these accessories ensure safe use. Our product information provides further system-related information on the surgical method. If there are any preoperative uncertainties relating to the implant, information must be obtained from SIGNUS. Instruments specially developed by SIGNUS to ensure safe application are available for use with the implant system.
SIGNUS Medizintechnik GmbH
Parallel connector CC
In Commercial Distribution

  • 04047844127360 ()

  • Ø5,5mm/5,5mm
AB0163-55055/S

  • Spinal bone screw, non-bioabsorbable
The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or more screws via the screw head and a rod using a force-fit or form-fit connection. Additional fixation elements, such as cross bars, hooks, connectors and washers, can also be used. The DIPLOMAT® pedicle screw system is applied temporarily to provide internal posterior stabilization until bone fusion in the lumbar or thoracic spine has taken place. The surgeon makes the final decision as to the indwelling time of the implant in the patient‘s body and the time when the implant is to be explanted. The pedicle screw system is implanted from a posterior approach. The implant is screwed into the vertebral body via the pedicle and it can be applied in a single segment or multiple segments. Implantation is facilitated by use of the specially developed accessories for inserting and positioning the implants. Only these accessories ensure safe use. Our product information provides further system-related information on the surgical method. If there are any preoperative uncertainties relating to the implant, information must be obtained from SIGNUS. Instruments specially developed by SIGNUS to ensure safe application are available for use with the implant system.
SIGNUS Medizintechnik GmbH
Parallel connector CC
In Commercial Distribution

  • 04047844127582 ()

  • Ø5,5mm/6,0mm
AB0163-55060

  • Bone-screw internal spinal fixation system connector
The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or more screws via the screw head and a rod using a force-fit or form-fit connection. Additional fixation elements, such as cross bars, hooks, connectors and washers, can also be used. The DIPLOMAT® pedicle screw system is applied temporarily to provide internal posterior stabilization until bone fusion in the lumbar or thoracic spine has taken place. The surgeon makes the final decision as to the indwelling time of the implant in the patient‘s body and the time when the implant is to be explanted. The pedicle screw system is implanted from a posterior approach. The implant is screwed into the vertebral body via the pedicle and it can be applied in a single segment or multiple segments. Implantation is facilitated by use of the specially developed accessories for inserting and positioning the implants. Only these accessories ensure safe use. Our product information provides further system-related information on the surgical method. If there are any preoperative uncertainties relating to the implant, information must be obtained from SIGNUS. Instruments specially developed by SIGNUS to ensure safe application are available for use with the implant system.
SIGNUS Medizintechnik GmbH
Parallel connector CC
In Commercial Distribution

  • 04047844127575 ()

  • Ø5,5mm/5,5mm
AB0163-55055

  • Bone-screw internal spinal fixation system connector
Comfortox Sterile syringes /with needle 3ml/cc 22gx1"
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
3ml/cc 22gx1"
In Commercial Distribution

  • 10817169023521 ()
  • 00817169023524 ()


  • Insulin syringe/needle, basic
Electroencephalograph kit
BELMONT INSTRUMENT CORPORATION
Kit (CC PRO)
Not in Commercial Distribution

  • 07290102932405 ()
681-OPT-338

  • Patient monitoring system module, electroencephalographic
IntelliSpace Critical Care and Anesthesia
Philips Medical Systems Hsg
Intellispace CC & Anesthesia
Not in Commercial Distribution

  • 00884838085565 ()
866148

  • Medical equipment clinical data interfacing software
ROD CONNECTOR PARALLEL CLOSE/CLOSE 15mm
SpineArt SA
TLF-PC CC 15-S
In Commercial Distribution

  • 07640332470176 ()

  • 15mm
TLF-PC CC 15-S

  • Bone-screw internal spinal fixation system, sterile
ROD CONNECTOR PARALLEL CLOSE/CLOSE 11mm
SpineArt SA
TLF-PC CC 11-S
In Commercial Distribution

  • 07640332470169 ()

  • 11mm
TLF-PC CC 11-S

  • Bone-screw internal spinal fixation system, sterile
PARALLEL CONNECTOR CC-TO
SpineArt SA
CPF-PC CC TO-S
In Commercial Distribution

  • 07640450864581 ()
CPF-PC CC TO-S

  • Bone-screw internal spinal fixation system, sterile
M400 OvuFirst Starter Pack - M426 OvuFirst Skin Worn Sensor and M032 OvuSense App
VIO HEALTHTECH LIMITED
M400
In Commercial Distribution

  • 05060508530121 ()


  • Thermometric fertility analyser
The CRI app provides the patient's individual-specific measure of the Compensatory Reserve Index.
FLASHBACK TECHNOLOGIES, INC.
CRI
In Commercial Distribution

  • 00860003025604 ()


  • Pulse oximeter probe, single-use
Smart Spirometer and Oximeter connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Spirobank Oxi
In Commercial Distribution

  • 08052990321711 ()


  • Expiratory peak flow meter, digital
  • Pulse oximeter
Smart Spirometer and Oximeter connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Smart One Oxi
In Commercial Distribution

  • 08052990321704 ()


  • Expiratory peak flow meter, digital
  • Pulse oximeter
Pressure PreventionGroup 1 Surfaces Product Description: APP Sys,Dlx,Variable Pressure,1/ea
Drive Devilbiss Healthcare
14001E
In Commercial Distribution

  • 00822383135809 ()
  • 50822383135804 ()


  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay system
MANUAL ENDOSCOPIC SPRAY APP. W/MIX TIP 5MM X 40CM,11:1 RATIO
Micromedics, Inc.
SA-3667
In Commercial Distribution

  • 00815634020184 ()
  • 10815634020181 ()
  • 20815634020188 ()


  • Open-surgery adhesive/sealant applicator, dual-channel
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageDataLoaded=false&pageMode=edit&deviceRecordKey=30865#
Aaren Scientific Inc.
EC-3
In Commercial Distribution

  • 00884872015894 ()


  • Posterior-chamber intraocular lens, pseudophakic
Compatible with Nobel Biocare NobelActive _ NobelReplace CC _ Nobel Parallel CC implants Consisting of: 1x Screw for impression copings
ZIRKONZAHN SRL
BSFE2404
In Commercial Distribution

  • D800BSFE2404 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Nobel Biocare NobelActive _ NobelReplace CC _ Nobel Parallel CC implants Consisting of: 1x Screw for impression copings
ZIRKONZAHN SRL
BSFE2403
In Commercial Distribution

  • D800BSFE2403 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Nobel Biocare NobelActive _ NobelReplace CC _ Nobel Parallel CC implants Consisting of: 1x Screw for impression copings
ZIRKONZAHN SRL
BSFE2402
In Commercial Distribution

  • D800BSFE2402 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Nobel Biocare NobelActive _ NobelReplace CC _ Nobel Parallel CC implants Consisting of: 1x Screw for impression copings
ZIRKONZAHN SRL
BSFE2401
In Commercial Distribution

  • D800BSFE2401 ()


  • Dental implant suprastructure, temporary, preformed, reusable
The Astroid Planning App is a cloud based software used for treatment planning of proton radiation therapy treatments.
DECIMAL, INC.
3.x
In Commercial Distribution

  • 00851147007120 ()


  • Radiation therapy software
No Description
Thought Technology Ltd.
SA4515
In Commercial Distribution

  • 07540191000630 ()


  • Psychophysiological biofeedback system
A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality worklist • Capture videos, images and audio files to be included in the study case. • Add notes and tags to each file (asset). • Upload any file to the Orpheus System • Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025124 ()
ML-EG30001

  • Radiology information system application software
A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality worklist • Capture videos, images and audio files to be included in the study case. • Add notes and tags to each file (asset). • Upload any file to the Orpheus System • Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025100 ()
MLL-EG30001

  • Radiology information system application software
Eversense NOW Remote Monitoring mobile application (iOS) is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information.
SENSEONICS, INCORPORATED
FG-5901-01-300
In Commercial Distribution

  • 00817491021267 ()
FG-5901-01-300

  • Implantable glucose monitoring system
NATRELLE 133FX With Sut Tab, 800cc.
Allergan, Inc.
133FX-15-T
Not in Commercial Distribution

  • 10888628004320 ()

  • 800 cc
133FX-15-T

  • Skin-port tissue expander
NATRELLE 133FX With Sut Tab, 650cc.
Allergan, Inc.
133FX-14-T
Not in Commercial Distribution

  • 10888628004313 ()

  • 650 cc
133FX-14-T

  • Skin-port tissue expander
NATRELLE 133FX With Sut Tab, 450cc.
Allergan, Inc.
133FX-12-T
Not in Commercial Distribution

  • 10888628004290 ()

  • 450 cc
133FX-12-T

  • Skin-port tissue expander
NATRELLE 133FV With Sut Tab, 850cc.
Allergan, Inc.
133FV-16-T
Not in Commercial Distribution

  • 10888628004276 ()

  • 850 cc
133FV-16-T

  • Skin-port tissue expander
NATRELLE 133FV With Sut Tab, 600cc.
Allergan, Inc.
133FV-14-T
Not in Commercial Distribution

  • 10888628004252 ()

  • 600 cc
133FV-14-T

  • Skin-port tissue expander
NATRELLE 133FV With Sut Tab, 400cc
Allergan, Inc.
133FV-12-T
Not in Commercial Distribution

  • 10888628004238 ()

  • 400 cc
133FV-12-T

  • Skin-port tissue expander
STYLE 410, LX, 195G BIOCELL |textured|contour|silicone
Allergan, Inc.
LX-410195
Not in Commercial Distribution

  • 10888628003293 ()

  • 195 cc
LX-410195

  • Silicone gel-filled breast implant, textured-surface
STYLE 410, FL, 320G BIOCELL |textured|contour|silicone
Allergan, Inc.
FL-410320
Not in Commercial Distribution

  • 10888628002784 ()

  • 320 cc
FL-410320

  • Silicone gel-filled breast implant, textured-surface
STYLE 410, FL, 250G BIOCELL |textured|contour|silicone
Allergan, Inc.
FL-410250
Not in Commercial Distribution

  • 10888628002777 ()

  • 250 cc
FL-410250

  • Silicone gel-filled breast implant, textured-surface
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