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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STRAIGHT PRE-MADE ABUTMENT H5 HEX 2,30 MM, PRE-KOH
SWEDEN & MARTINA SPA
A-MD-TS-EX230-5
In Commercial Distribution

  • D7701096033 ()
A-MD-TS-EX230-5

  • Dental implant suprastructure, permanent, preformed
M10345 - Salmonella Monovalent H Antiserum - Factor H-5 - 2ml
MAST GROUP LIMITED
M10345
In Commercial Distribution

  • 15060392375881 ()
M10345

  • Multiple Salmonella species culture isolate antigen IVD, kit, agglutination
TRIAL L12 x W14 x A7 x H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809489299392 ()
AC.2025

  • Bone-screw internal spinal fixation system, non-sterile
TRIAL L14 x W16 x A7 x H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809489299149 ()
AC.2041

  • Bone-screw internal spinal fixation system, non-sterile
Galaxy ACIF cage H5 x W14 x L12
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809263396002 ()

  • Height: 5 Millimeter
  • Width 14mm, Length 12mm
NC551412

  • Bone-screw internal spinal fixation system, non-sterile
Galaxy ACIF cage H5 x W16 x L14
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809263396101 ()

  • Height: 5 Millimeter
  • Width 16mm, Length 14mm
NC551614

  • Bone-screw internal spinal fixation system, non-sterile
Galaxy ACIF cage H5 x W15 x L14
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809263396057 ()

  • Width 15mm, Length 14mm
  • Height: 5 Millimeter
NC551514

  • Bone-screw internal spinal fixation system, non-sterile
ACIF Depth Stop Trial, MD, 12°, H5/H6mm
CTL Medical Corporation
113.7475
In Commercial Distribution

  • 00841732165168 ()


  • Metallic spinal interbody fusion cage
ACIF Depth Stop Trial, SM, 12°, H5/H6mm
CTL Medical Corporation
113.7465
In Commercial Distribution

  • 00841732165137 ()


  • Metallic spinal interbody fusion cage
ACIF Depth Stop Trial, SM, Lordotic, H5/H6mm
CTL Medical Corporation
113.7415
In Commercial Distribution

  • 00841732129115 ()


  • Spinal implant trial
ACIF Depth Stop Trial, MD, Parallel, H5/H6
CTL Medical Corporation
113.7425
In Commercial Distribution

  • 00841732125483 ()


  • Spinal implant trial
ACIF Depth Stop Trial, SM, Parallel, H5/H6mm
CTL Medical Corporation
113.7405
In Commercial Distribution

  • 00841732125452 ()


  • Spinal implant trial
Aadva™ IOS 100: IOS cart, IOS Handpiece (via USB connection), CPU (onboard computer), G.U.I. touchscreen, holder inserts bags of 10, plug, IFUs (includes: Quick Start Guide & Owners manual).
Gc America Inc.
940502
In Commercial Distribution

  • J0229405021 ()
940502

  • Dental milling system, CAD/CAM, laboratory
Sleep Apnea Notification Feature iOS (version 1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949116209 ()


  • Self-care monitoring/reporting software
AirStrip Cardiology, Patient Monitoring and OB - Client iOS
Airstrip Technologies, Inc.
2001
In Commercial Distribution

  • B15320010 ()


  • Bedside monitor remote-viewing software, physiological parameter
NobelProcera® IOS Model Implant Replica CC WP
Nobel Biocare AB
38191
In Commercial Distribution

  • 07332747212570 ()
38191

  • Dental implant suprastructure, temporary, preformed, single-use
NobelProcera® IOS Model Implant Replica CC RP
Nobel Biocare AB
38190
In Commercial Distribution

  • 07332747212563 ()
38190

  • Dental implant suprastructure, temporary, preformed, single-use
NP IOS Model Implant Replica Conical Connection NP
Nobel Biocare AB
38189
In Commercial Distribution

  • 07332747212556 ()
38189

  • Dental implant suprastructure, temporary, preformed, single-use
NobelProcera® IOS Replica Insertion Tool CC WP
Nobel Biocare AB
38204
In Commercial Distribution

  • 07332747096422 ()
38204

  • Dental implant suprastructure, temporary, preformed, reusable
NobelProcera® IOS Replica Insertion Tool CC RP
Nobel Biocare AB
38203
In Commercial Distribution

  • 07332747096415 ()
38203

  • Dental implant suprastructure, temporary, preformed, reusable
NobelProcera® IOS Replica Insertion Tool CC NP
Nobel Biocare AB
38201
In Commercial Distribution

  • 07332747096408 ()
38201

  • Dental implant suprastructure, temporary, preformed, reusable
NobelProcera® IOS Replica Insertion Tool CC 3.0
Nobel Biocare AB
38200
In Commercial Distribution

  • 07332747096392 ()

  • Outer Diameter: 3.000 Millimeter
38200

  • Dental implant suprastructure, temporary, preformed, reusable
NobelProcera® IOS Model Implant Replica CC WP
Nobel Biocare AB
38191
In Commercial Distribution

  • 07332747096316 ()
38191

  • Dental implant suprastructure, temporary, preformed, single-use
NobelProcera® IOS Model Implant Replica CC RP
Nobel Biocare AB
38190
In Commercial Distribution

  • 07332747096309 ()
38190

  • Dental implant suprastructure, temporary, preformed, single-use
NP IOS Model Implant Replica Conical Connection NP
Nobel Biocare AB
38189
In Commercial Distribution

  • 07332747096293 ()
38189

  • Dental implant suprastructure, temporary, preformed, single-use
NobelProcera® IOS Model Implant Replica CC 3.0
Nobel Biocare AB
38188
In Commercial Distribution

  • 07332747096286 ()

  • Outer Diameter: 3.000 Millimeter
38188

  • Dental implant suprastructure, temporary, preformed, single-use
NobelProcera® IOS Model Implant Replica CC 3.0
Nobel Biocare AB
38188
In Commercial Distribution

  • 07332747212549 ()

  • Outer Diameter: 3.000 Millimeter
38188

  • Dental implant suprastructure, temporary, preformed, single-use
Transducer C9-4ec as part of Lumify 5.1 iOS
Philips Ultrasound LLC
300013145921
In Commercial Distribution

  • 00884838123762 ()


  • Rectal/vaginal ultrasound imaging transducer
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices.
ELI LILLY AND COMPANY
MA7723 IOS
In Commercial Distribution

  • 00300021107550 ()
MA7723001AM

  • Medication reminder application software
The device is an optical impression system. It is used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer-aided design (CAD) and computer-aided manufacturing (CAM) of dental restorative prosthetic devices.
CEFLA SOCIETA' COOPERATIVA
NewTom IOS
In Commercial Distribution

  • 08033837932970 ()
70960000

  • Intraoral optical scanning system
  • Dental milling system, CAD/CAM, chairside
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