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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Biim Android App, P1.3.2
Biim Ultrasound AS
P001418
In Commercial Distribution

  • 07090045490310 ()
P001418

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim Android App, P1.3.1
Biim Ultrasound AS
P001403
In Commercial Distribution

  • 07090045490235 ()
P001403

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim Android App, P1.3
Biim Ultrasound AS
P001228
In Commercial Distribution

  • 07090045490198 ()
P001228

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim Android App, P1.2
Biim Ultrasound AS
P001158
In Commercial Distribution

  • 07090045490150 ()
P001158

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim Android App, P1.1
Biim Ultrasound AS
P001118
In Commercial Distribution

  • 07090045490020 ()
P001118

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
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
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
Transducer C9-4ec as part of Lumify 5.1 iOS
Philips Ultrasound LLC
300013145921
In Commercial Distribution

  • 00884838123762 ()


  • Rectal/vaginal ultrasound imaging transducer
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 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
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
SURGICAL CHISELS 13K/TG TITANIUM 3.5 / 3 mm
Power Dental U.S.A. Inc.
2001T
In Commercial Distribution

  • D9432001T00 ()
2001T

  • Dressing/utility forceps, scissors-like, reusable
  • Periodontal hoe
TG 8MM 3# FOAM CONDYLAR BK/BK HOOK
MEDI MANUFACTURING, INC.
201561
In Commercial Distribution

  • 00636257156186 ()


  • Knee support orthosis
TG Ab Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10492692
In Commercial Distribution

  • 00630414580722 ()
10492692

  • Thyroglobulin antibody IVD, control
Titan Design 4.8mm Tg Hex Abutment Analog Aluminum
TITAN IMPLANT INC
TN-48TGHAA-AL
In Commercial Distribution

  • 00842448112347 ()


  • Dental implant abutment analog, laboratory
XiVE® TG Lab Set Gold Bar Coping
Dentsply Implants Manufacturing GmbH
32259600
Not in Commercial Distribution

  • EFRI322596002 ()
25-9600

  • Dental implant suprastructure kit
XiVE® TG Lab Set Soldering Analog Bar
Dentsply Implants Manufacturing GmbH
32259301
Not in Commercial Distribution

  • EFRI322593012 ()
25-9301

  • Dental implant suprastructure kit
XiVE® TG Lab Set Soldering Analog Bridge
Dentsply Implants Manufacturing GmbH
32259300
Not in Commercial Distribution

  • EFRI322593002 ()
25-9300

  • Dental implant suprastructure kit
XiVE® TG Lab Set Soldering Analog Bar
Dentsply Implants Manufacturing GmbH
32254106
Not in Commercial Distribution

  • EFRI322541062 ()
25-4106

  • Dental implant suprastructure kit
XiVE® TG Lab Set Soldering Analog Bridge
Dentsply Implants Manufacturing GmbH
32254105
Not in Commercial Distribution

  • EFRI322541052 ()
25-4105

  • Dental implant suprastructure kit
T-CONNECT FOR SINGLE CROWN PRE/KOH TG W
SWEDEN & MARTINA SPA
A-TG-BASTZR-S-W
In Commercial Distribution

  • D7701023833 ()
A-TG-BASTZR-S-W

  • Dental implant suprastructure, permanent, preformed
T-CONNECT FOR SINGLE CROWN PRE/KOH TG M
SWEDEN & MARTINA SPA
A-TG-BASTZR-S-M
In Commercial Distribution

  • D7701002123 ()
A-TG-BASTZR-S-M

  • Dental implant suprastructure, permanent, preformed
TRANSFER ECHO FOR PRE-KOH TG IMPLANTS, WIDE PLATFORM
SWEDEN & MARTINA SPA
A-TG-CAMTRA-W
In Commercial Distribution

  • D7700887003 ()
A-TG-CAMTRA-W

  • Dental implant/prosthesis surgical procedure kit
TRANSFER ECHO FOR PRE-KOH TG IMPLANTS, MEDIUM PLATFORM
SWEDEN & MARTINA SPA
A-TG-CAMTRA-M
In Commercial Distribution

  • D7700886993 ()
A-TG-CAMTRA-M

  • Dental implant/prosthesis surgical procedure kit
SCREW M2 FOR RIP.ABUTMENT PRE-KOH TG, WIDE, MAGENTA
SWEDEN & MARTINA SPA
A-TG-VABUR-W
In Commercial Distribution

  • D7700884153 ()
A-TG-VABUR-W

  • Dental implant suprastructure, permanent, preformed
SCREW M1.8 FOR RIP.ABUTMENT PRE-KOH TG, MEDIUM, GREEN
SWEDEN & MARTINA SPA
A-TG-VABUR-M
In Commercial Distribution

  • D7700884143 ()
A-TG-VABUR-M

  • Dental implant suprastructure, permanent, preformed
ANALOGUE FOR PRE-KOH TG ABUT. WIDE PLATFORM, MAGENTA
SWEDEN & MARTINA SPA
A-TG-ANABU-W
In Commercial Distribution

  • D7700880673 ()
A-TG-ANABU-W

  • Dental implant suprastructure, permanent, preformed
ANALOGUE FOR PRE-KOH TG ABUT. MEDIUM PLATFORM, GREEN
SWEDEN & MARTINA SPA
A-TG-ANABU-M
In Commercial Distribution

  • D7700880663 ()
A-TG-ANABU-M

  • Dental implant suprastructure, permanent, preformed
HEALING CAP FOR ABUTMENT PRE-KOH TG, WIDE PLATFORM
SWEDEN & MARTINA SPA
A-TG-CAPGABU-W
In Commercial Distribution

  • D7700880523 ()
A-TG-CAPGABU-W

  • Dental implant suprastructure, permanent, preformed
HEALING CAP FOR ABUTMENT PRE-KOH TG, MEDIUM PLATFORM
SWEDEN & MARTINA SPA
A-TG-CAPGABU-M
In Commercial Distribution

  • D7700880513 ()
A-TG-CAPGABU-M

  • Dental implant suprastructure, permanent, preformed
NON REP. ABUTMENT FOR PRE-KOH TG WIDE PLATFORM
SWEDEN & MARTINA SPA
A-TG-ABUD-W
In Commercial Distribution

  • D7700880483 ()
A-TG-ABUD-W

  • Dental implant suprastructure, permanent, preformed
NON REP. ABUTMENT FOR PRE-KOH TG MEDIUM PLATFORM
SWEDEN & MARTINA SPA
A-TG-ABUD-M
In Commercial Distribution

  • D7700880473 ()
A-TG-ABUD-M

  • Dental implant suprastructure, permanent, preformed
POST SCREWS M 2 PRE-KOH TG, MAGENTA (10PCS)
SWEDEN & MARTINA SPA
A-TG-VM-200-10
In Commercial Distribution

  • D7700874893 ()
A-TG-VM-200-10

  • Dental implant suprastructure, permanent, preformed
POST SCREWS M 1.8 PRE-KOH TG, GREEN (10PCS)
SWEDEN & MARTINA SPA
A-TG-VM-180-10
In Commercial Distribution

  • D7700874883 ()
A-TG-VM-180-10

  • Dental implant suprastructure, permanent, preformed
PRE-MADE REP. POST STRAIGHT PROF.,H7, PREKOH TG
SWEDEN & MARTINA SPA
A-TG-MR-W-70
In Commercial Distribution

  • D7700874773 ()
A-TG-MR-W-70

  • Dental implant suprastructure, permanent, preformed
PRE-MADE REP. POST STRAIGHT PROF.,H7, PREKOH TG
SWEDEN & MARTINA SPA
A-TG-MR-M-70
In Commercial Distribution

  • D7700874763 ()
A-TG-MR-M-70

  • Dental implant suprastructure, permanent, preformed
PRE-MADE REP. POST STRAIGHT PROF.,H4, PREKOH TG
SWEDEN & MARTINA SPA
A-TG-MR-W-40
In Commercial Distribution

  • D7700874753 ()
A-TG-MR-W-40

  • Dental implant suprastructure, permanent, preformed
PRE-MADE REP. POST STRAIGHT PROF.,H4, PREKOH TG
SWEDEN & MARTINA SPA
A-TG-MR-M-40
In Commercial Distribution

  • D7700874743 ()
A-TG-MR-M-40

  • Dental implant suprastructure, permanent, preformed
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