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
SPECTRUM MEDICAL SRL
VT75-E1
In Commercial Distribution

  • 18051160301864 ()


  • Extracorporeal membrane oxygenator
Annalise Triage is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
3.4.1
In Commercial Distribution

  • G140ANNALISEENTP40 ()


  • Radiology DICOM image processing application software
Annalise Enterprise is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
3.3.0
In Commercial Distribution

  • G140ANNALISEENTP30 ()


  • Radiology DICOM image processing application software
Annalise Enterprise is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
3.2.0
In Commercial Distribution

  • G140ANNALISEENTP20 ()


  • Radiology DICOM image processing application software
Serological Conf., Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
73518
In Commercial Distribution

  • 05713106735183 ()
73518

  • Multiple Salmonella species antigen IVD, control
Serological Conf., Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
44807
In Commercial Distribution

  • 05713106448076 ()
44807

  • Multiple Salmonella species antigen IVD, control
ACMI INSTRUMENT AI VERSITIP ADAPTOR FOR 4.0 MM AND 5.0 MM LIGHT GUIDES INTENDED TO INTERFACE SMITH and NEPHEW GEMINI UNIVERSAL FIBER OPTIC LIGHT CABLES WITH ACMI ENDOSCOPES
Smith & Nephew, Inc.
2141
In Commercial Distribution

  • 03596010103291 ()
2141

  • Endoscopic light source adaptor
WIRE/PIN CUTTER DOUBLE ACTION TUNGSTEN CARBIDE CUTS WIRE UP TO 2.2 MILLIMETERS 15 DEGREE ANGLE 8.75 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1103-102Q
In Commercial Distribution

  • 00192896093362 ()

  • 5 Degree Tip
  • Length: 8.75 Inch
  • Cuts up to 2.2 Millimeters
  • 15 Degree Tip
1103-102Q

  • Orthopaedic implantable-device cutter
Interface Kit designed to allow mounting of Matrx E2 Backs onto a Quantum (Pride Mobility) Tilt/Recline wheelchair seating system.
Motion Concepts Inc
QUANMH-E2
In Commercial Distribution

  • 07540147001308 ()
QUANMH-E2

  • Wheelchair bracket/mount
Interface Kit designed to allow mounting of Matrx Elite Backs onto a Quantum (Pride Mobility) Tilt/Recline wheelchair seating system.
Motion Concepts Inc
QUANMH
In Commercial Distribution

  • 07540147001278 ()
QUANMH

  • Wheelchair bracket/mount
Spinous Process Fusion Plate
Pioneer Surgical Technology, Inc.
83-00-16
Not in Commercial Distribution

83-00-16

  • Spinal fixation plate, non-bioabsorbable
Spinous Process Fusion Plate
Pioneer Surgical Technology, Inc.
83-00-14
Not in Commercial Distribution

83-00-14

  • Spinal fixation plate, non-bioabsorbable
Spinous Process Fusion Plate
Pioneer Surgical Technology, Inc.
83-00-12
Not in Commercial Distribution

83-00-12

  • Spinal fixation plate, non-bioabsorbable
Spinous Process Fusion Plate
Pioneer Surgical Technology, Inc.
83-00-10
Not in Commercial Distribution

83-00-10

  • Spinal fixation plate, non-bioabsorbable
Spinous Process Fusion Plate
Pioneer Surgical Technology, Inc.
83-00-08
Not in Commercial Distribution

83-00-08

  • Spinal fixation plate, non-bioabsorbable
No Description
PIVOTAL HEALTH SOLUTIONS, INC.
Q400P
In Commercial Distribution

  • 00850020142422 ()


  • Traction table, line-powered
BACFUSE,INLINE TORQUE LIMITING HANDLE,UL
Pioneer Surgical Technology, Inc.
725-016
Not in Commercial Distribution

  • 00846468000516 ()

  • 30in-lbs (Torque)
725-016

  • General internal orthopaedic fixation system implantation kit
Guide Sleeve
Pioneer Surgical Technology, Inc.
83-SLEEVE-12
Not in Commercial Distribution

83-SLEEVE-12

  • Orthopaedic implantation sleeve, reusable
Guide Sleeve
Pioneer Surgical Technology, Inc.
83-SLEEVE-10
Not in Commercial Distribution

83-SLEEVE-10

  • Orthopaedic implantation sleeve, reusable
Guide Sleeve
Pioneer Surgical Technology, Inc.
83-SLEEVE-08
Not in Commercial Distribution

83-SLEEVE-08

  • Orthopaedic implantation sleeve, reusable
Rasp
Pioneer Surgical Technology, Inc.
83-RASP-16
Not in Commercial Distribution

83-RASP-16

  • Bone file/rasp, manual, reusable
Rasp
Pioneer Surgical Technology, Inc.
83-RASP-14
Not in Commercial Distribution

83-RASP-14

  • Bone file/rasp, manual, reusable
Rasp
Pioneer Surgical Technology, Inc.
83-RASP-12
Not in Commercial Distribution

83-RASP-12

  • Bone file/rasp, manual, reusable
Rasp
Pioneer Surgical Technology, Inc.
83-RASP-10
Not in Commercial Distribution

83-RASP-10

  • Bone file/rasp, manual, reusable
Rasp
Pioneer Surgical Technology, Inc.
83-RASP-08
Not in Commercial Distribution

83-RASP-08

  • General internal orthopaedic fixation system implantation kit
Lock Plate Inserter
Pioneer Surgical Technology, Inc.
83-L-INSERTER
Not in Commercial Distribution

83-L-INSERTER

  • General internal orthopaedic fixation system implantation kit
Compressor
Pioneer Surgical Technology, Inc.
83-L-COMPRESSOR
Not in Commercial Distribution

83-L-COMPRESSOR

  • General internal orthopaedic fixation system implantation kit
Driver
Pioneer Surgical Technology, Inc.
83-DRIVER
Not in Commercial Distribution

83-DRIVER

  • Orthopaedic counter-torque/rod-pushing instrument
Dilator
Pioneer Surgical Technology, Inc.
83-DILATOR-08
Not in Commercial Distribution

83-DILATOR-08

  • Nerve/vessel retractor
Dilator
Pioneer Surgical Technology, Inc.
83-DILATOR-05
Not in Commercial Distribution

83-DILATOR-05

  • Nerve/vessel retractor
Compressor
Pioneer Surgical Technology, Inc.
83-COMPRESSOR
Not in Commercial Distribution

  • 00846468002701 ()
83-COMPRESSOR

  • General internal orthopaedic fixation system implantation kit
Instrument Case
Pioneer Surgical Technology, Inc.
83-CASE
Not in Commercial Distribution

  • 00846468002695 ()
83-CASE

  • General internal orthopaedic fixation system implantation kit
Barrel Plate Inserter
Pioneer Surgical Technology, Inc.
83-B-INSERTER
Not in Commercial Distribution

83-B-INSERTER

  • General internal orthopaedic fixation system implantation kit
Torque Limiting Handle
Pioneer Surgical Technology, Inc.
83-TORQHANDLE
Not in Commercial Distribution

83-TORQHANDLE

  • General internal orthopaedic fixation system implantation kit
90° Sizing Distractor
Pioneer Surgical Technology, Inc.
83-THINSIZER-90
Not in Commercial Distribution

83-THINSIZER-90

  • General internal orthopaedic fixation system implantation kit
Guide Sleeve
Pioneer Surgical Technology, Inc.
83-SLEEVE-16
Not in Commercial Distribution

83-SLEEVE-16

  • Orthopaedic implantation sleeve, reusable
Guide Sleeve
Pioneer Surgical Technology, Inc.
83-SLEEVE-14
Not in Commercial Distribution

83-SLEEVE-14

  • Orthopaedic implantation sleeve, reusable
No Description
TELEA ELECTRONIC ENGEENERING SRL
4,5m
In Commercial Distribution

  • 08034055290644 ()
2505013

  • Electrosurgical cable adaptor
No Description
SPECTRUM MEDICAL SRL
DL24F-V1
In Commercial Distribution

  • 08051160301768 ()


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
No Description
SPECTRUM MEDICAL SRL
DL27F-V1
In Commercial Distribution

  • 08051160301751 ()


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
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