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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Accessories
CeramTec Schweiz GmbH
301251
In Commercial Distribution

  • 07640161394780 ()
301251

  • Dental implant suprastructure, temporary, preformed, single-use
Accessories
CeramTec Schweiz GmbH
301249
In Commercial Distribution

  • 07640161394766 ()
301249

  • Dental implant suprastructure, temporary, preformed, single-use
CHECKLIST APP This app requires core.portal. The checklist app is a universal questionnaire and checklist system for collecting information during surgery. Checklists can be defined as customer-specific multilingual templates. The checklists are displayed in accordance with the language selected in the core.browser. The app generates a PDF report with the demographic patient data, information about the surgical intervention, a logo and the recorded data. The report is part of the documentation. The app does not spread the information collected.
Richard Wolf GmbH
5597706
Not in Commercial Distribution

  • 04055207070086 ()
5597706

  • Operating room audiovisual data/device management system application software
M400 OvuFirst Starter Pack - M426 OvuFirst Skin Worn Sensor and M032 OvuSense App
VIO HEALTHTECH LIMITED
M400
In Commercial Distribution

  • 05060508530121 ()


  • Thermometric fertility analyser
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
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
The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries. System includes one TST-11 tip.
3shape Trios A/S
L1P-1F
In Commercial Distribution

  • 05902729754149 ()


  • Intraoral optical scanning system
The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries. System includes five TST-11 tips.
3shape Trios A/S
L1P-1F
In Commercial Distribution

  • 05902729753722 ()


  • Intraoral optical scanning system
Care Assist
Philips Medical Systems Hsg
Care Assist iOS 4.2
In Commercial Distribution

  • 00884838123717 ()
989803221531

  • Centralized patient monitor
No Description
STARKEY LABORATORIES, INC.
“ProAkustik name” for iOS
In Commercial Distribution

  • 00842318130839 ()


  • Audiometric/hearing device software
No Description
STARKEY LABORATORIES, INC.
“KIND name” for iOS
In Commercial Distribution

  • 00842318130815 ()


  • Audiometric/hearing device software
Pressure Prevention Group 1 Surfaces Product Description APP Sys,Dlx,Variable Pressure,1/ea
Drive Devilbiss Healthcare
146-14001E
In Commercial Distribution

  • 00612479258181 ()


  • Alternating-pressure bed mattress overlay system
  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator
Self Sealing Sterilization Pouch, 10"x 16"https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
MicroCare, LLC
PM1016
In Commercial Distribution

  • H816MPM10160 ()
  • H816MPM10161 ()
  • H816PM10161 ()
PM1016-1

  • Sterilization packaging, single-use
Jacobson Needle Holder Micro Tungsten Grip Straight 21cmhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
KOROS U.S.A., INC.
7064-30
In Commercial Distribution

  • 00840199506125 ()
  • 10840199506122 ()

  • 9x12mm
7064-30

  • Suturing needle holder, reusable
Pressure PreventionGroup 1 Surfaces Product Description: APP Sys,Standard,Fixed Pressure,1/ea,RTL
Drive Devilbiss Healthcare
14002E
In Commercial Distribution

  • 00822383135816 ()
  • 50822383135811 ()


  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay system
Pressure PreventionGroup 1 Surfaces Product Description: APP Pad, w/End Flaps,1/ea, RTL
Drive Devilbiss Healthcare
14003-EF
In Commercial Distribution

  • 50822383110764 ()
  • 00822383110769 ()


  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay system
SmartJet® Dual Liquid Applicator Kit, LK/7 SmartJet 7 in. Liquid App. Kit
TERUMO BCT, INC.
51454
Not in Commercial Distribution

  • 05020583514546 ()
  • 35020583514547 ()


  • Haematological concentrate/haemostatic agent applicator
Beurer Fertility Convenience Kit with Pearl App Each kit contains: 15 FSH test strips, 15 LH test strips, 2 hCG test strips (pregnancy test), Access (activation code) for the Pearl Fertility App.
BEURER NORTH AMERICA, L.P.
OT80
In Commercial Distribution

  • 00850003500478 ()
  • 10850003500475 ()
  • 20850003500472 ()
792.97

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
  • Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-42109
Not in Commercial Distribution

  • 00814356029994 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-42108
Not in Commercial Distribution

  • 00814356029987 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-42107
Not in Commercial Distribution

  • 00814356029970 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-42106
Not in Commercial Distribution

  • 00814356029963 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-42105
Not in Commercial Distribution

  • 00814356029956 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-42103
Not in Commercial Distribution

  • 00814356029949 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-42104
Not in Commercial Distribution

  • 00814356029932 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-42102
Not in Commercial Distribution

  • 00814356029925 ()


  • Dental appliance fabrication material, ceramic
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