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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FreeStyle Libre 2 App Android US
ABBOTT DIABETES CARE INC
71857-01
In Commercial Distribution

  • 00357599809003 ()
71857-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
IVA ACIF CAGE (Flat) L12 x W14 x A10 x H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039829861 ()
ACF.12141005

  • Spinal fixation plate, non-bioabsorbable
IVA ACIF CAGE (Flat) L15 x W17 x A10 x H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039829557 ()
ACF.15171005

  • Spinal fixation plate, non-bioabsorbable
IVA ACIF CAGE (Flat) L14 x W16 x A10 x H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039829441 ()
ACF.14161005

  • Spinal fixation plate, non-bioabsorbable
30GR ANGLED PAD ABUT., H5 MM D.5.00 MM EX.2.30
SWEDEN & MARTINA SPA
AS-PAD-AA500-305
In Commercial Distribution

  • D7701254113 ()
AS-PAD-AA500-305

  • Dental implant suprastructure, permanent, preformed
17GR ANGLED PAD ABUT., H5 MM D.5.00 MM EX.2.30
SWEDEN & MARTINA SPA
AS-PAD-AA500-175
In Commercial Distribution

  • D7701254093 ()
AS-PAD-AA500-175

  • Dental implant suprastructure, permanent, preformed
30GR ANGLED PAD ABUT., H5 MM D.4.25 MM EX.2.30
SWEDEN & MARTINA SPA
AS-PAD-AA425-305
In Commercial Distribution

  • D7701245913 ()
AS-PAD-AA425-305

  • Dental implant suprastructure, permanent, preformed
17GR ANGLED PAD ABUT., H5 MM D.4.25 MM EX.2.30
SWEDEN & MARTINA SPA
AS-PAD-AA425-175
In Commercial Distribution

  • D7701245893 ()
AS-PAD-AA425-175

  • Dental implant suprastructure, permanent, preformed
SCALER, SINGLE END, TRADE IN, SICKLE N5 (H5), #6 RELYANT HANDLE
NORDENT MANUFACTURING INC
TSCN5
In Commercial Distribution

  • 00840018623170 ()


  • Manual dental scaler, reusable
Scan Body with Screw Compatible with Osstem (Hiossen) TSIII Regular IOS
Biodenta Swiss AG
CAD-SBOTS45
In Commercial Distribution

  • 07640169731419 ()
CAD-SBOTS45

  • Dental implant abutment analog, intraoral-scanning, single-use
Scan Body with Screw Compatible with Osstem (Hiossen) TSIII Mini IOS
Biodenta Swiss AG
CAD-SBOTS35
In Commercial Distribution

  • 07640169731402 ()
CAD-SBOTS35

  • Dental implant abutment analog, intraoral-scanning, single-use
Insertion Tool IOS Implant Replica Nobel Biocare N1™ NP/RP
Nobel Biocare AB
300966
In Commercial Distribution

  • 07332747162905 ()
300966

  • Dental implant suprastructure, temporary, preformed, reusable
SOFTWARE 9734472 SONONAV CAL APP FOR SC
MEDTRONIC NAVIGATION, INC.
9734472
In Commercial Distribution

  • 00643169183407 ()


  • Multi-purpose stereotactic surgery system
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
FLEXICARE MEDICAL LIMITED
038-94-620U
In Commercial Distribution

  • 05055788777694 ()


  • Laryngeal mask airway, single-use
OB V2 RING KIT TI LG-No App
OSSUR AMERICAS, INC.
515500V2
Not in Commercial Distribution

  • 05690977308695 ()
515500V2

  • Cervical spine immobilization head ring
OB V2 RING KIT TI STD-No App
OSSUR AMERICAS, INC.
515400V2
Not in Commercial Distribution

  • 05690977308688 ()
515400V2

  • Cervical spine immobilization head ring
OB V2 RING KIT TI SM-No App
OSSUR AMERICAS, INC.
515300V2
Not in Commercial Distribution

  • 05690977308671 ()
515300V2

  • Cervical spine immobilization head ring
Rabbit Polyclonal Anti-Human Amyloid Precursor Protein (APP)
RICHARD-ALLAN SCIENTIFIC COMPANY
RB-9023-R7
In Commercial Distribution

  • 00673693398602 ()

  • Total Volume: 7 Milliliter


  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Rabbit Polyclonal Anti-Human Amyloid Precursor Protein (APP)
RICHARD-ALLAN SCIENTIFIC COMPANY
RB-9023-P1
In Commercial Distribution

  • 00673693398572 ()

  • Total Volume: 0.5 Milliliter


  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Rabbit Polyclonal Anti-Human Amyloid Precursor Protein (APP)
RICHARD-ALLAN SCIENTIFIC COMPANY
RB-9023-P0
In Commercial Distribution

  • 00673693398565 ()

  • Total Volume: 0.1 Milliliter


  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Rabbit Polyclonal Anti-Human Amyloid Precursor Protein (APP)
RICHARD-ALLAN SCIENTIFIC COMPANY
RB-9023-P
In Commercial Distribution

  • 00673693398558 ()

  • Total Volume: 1 Milliliter


  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75751
Not in Commercial Distribution

  • 07392532242380 ()
75751

  • Rectal irrigation system application software
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Bio Compression Systems, Inc
G8-3035-SH-M-L
In Commercial Distribution

  • 00812311029119 ()


  • Multi-chamber venous compression system garment, reusable
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Bio Compression Systems, Inc
G8-3035-SH-M-L-BT
In Commercial Distribution

  • 00812311020062 ()


  • Multi-chamber venous compression system garment, reusable
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
MAR COR PURIFICATION, INC.
102M16B2E
In Commercial Distribution

  • 00817492021969 ()

  • Width: 38 Inch
  • Depth: 29 Inch
  • Height: 80.5 Inch
  • Weight: 783 Pound


  • Reverse-osmosis water purification system
APP PAD W/O HEAD & FOOT FLAPS
COMPASS HEALTH BRANDS CORP.
1002
In Commercial Distribution

  • 30815067040170 ()
  • 00815067040179 ()


  • Alternating-pressure bed mattress overlay, reusable
A mobile app for HANSATON hearing instruments
Sonova AG
088-5018
In Commercial Distribution

  • 07613389610932 ()


  • Audiometric/hearing device software
App Control for ACRL-9100 Device v.1
COMPASS HEALTH BRANDS CORP.
ACRL-9100APP
In Commercial Distribution



  • Physical therapy transcutaneous neuromuscular electrical stimulation system
App Control for ACRL-9100 Device v.0
COMPASS HEALTH BRANDS CORP.
ACRL-9100APP
Not in Commercial Distribution

  • 00023601091000 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
APP System, Standard, 220 Volt, 1/ea
Drive Devilbiss Healthcare
14002E-220
Not in Commercial Distribution

  • 10822383227785 ()
  • 00822383227788 ()


  • Alternating-pressure bed mattress overlay system
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay, reusable
Symphony True LAL & APP Matt Repl Sys
Drive Devilbiss Healthcare
14500
Not in Commercial Distribution

  • 00822383580913 ()


  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure bed mattress overlay system
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75751
In Commercial Distribution

75751

  • Rectal irrigation system application software
SFTWR CSS7201 GRDN MBL APP ANDRD V4.1.1
MEDTRONIC MINIMED, INC.
CSS7201
In Commercial Distribution

  • 00763000381097 ()


  • Patient health record information system application software
SW APP A71300 SCS CLINICIAN TRIALING 2.0
MEDTRONIC, INC.
A71300
In Commercial Distribution

  • 00763000533199 ()


  • Multiple active implantable device programmer
SW D00U027 SS LINQ II PLATFORM APP
MEDTRONIC, INC.
D00U027
In Commercial Distribution

  • 00763000891091 ()


  • Implantable cardiac device management application software
SW MMT-8061 INPEN 2.0 ANDROID APP US
MEDTRONIC MINIMED, INC.
MMT-8061
In Commercial Distribution

  • 00763000974596 ()


  • Empty self-injector, mechanical
G5 Mobile Android App Stand Alone Software
Dexcom, Inc.
SW10940
In Commercial Distribution

  • 00386270000293 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Cervical Rasp with Hard stop L12 x W14 x A7 x H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039876674 ()
CD.AC.0036

  • Spinal fixation plate, non-bioabsorbable
Scan Body with Screw Compatible with Astra Tech OsseoSpeed 3.5/4.0 IOS
Biodenta Swiss AG
CAD-SBATOS3545
In Commercial Distribution

  • 07640169736346 ()
CAD-SBATOS3545

  • Dental implant abutment analog, intraoral-scanning, single-use
Eko mobile app for Android platforms for use with Eko products.
Eko Devices, Inc.
1.2.9
In Commercial Distribution

  • 00863609000341 ()


  • Medical equipment clinical data interfacing software
No Description
NFANT LABS LLC
1
In Commercial Distribution

  • 00861410000246 ()
NA4

  • Biofeedback system application software
No Description
Boston Brace International, Inc.
SENSOR-MA-V1
In Commercial Distribution

  • 00860013109813 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
for Android
COCHLEAR LIMITED
NSA-2 / v5
In Commercial Distribution

  • 09321502062190 ()
P1834165

  • Audiometric/hearing device software
for Android
COCHLEAR LIMITED
NSA-2 / v4
In Commercial Distribution

  • 09321502060479 ()
P1787373

  • Audiometric/hearing device software
The .decimal Astroid Dosimetry App device is used for planning and analysis of proton radiation therapy treatments.
DECIMAL, INC.
1.0
In Commercial Distribution

  • 00851147007076 ()


  • Radiation therapy software
Accessory to ERT's Asthma Monitor device for professional users
eResearchTechnology GmbH
2.x
In Commercial Distribution

  • 04057155000603 ()


  • Expiratory peak flow meter, digital
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3537
In Commercial Distribution

  • 00301933537015 ()
85498754

  • Self-care monitoring/reporting software
Diabetes Management Software
ASCENSIA DIABETES CARE US INC.
3536
In Commercial Distribution

  • 00301933536018 ()
85498770

  • Self-care monitoring/reporting software
No Description
CURBELL MEDICAL PRODUCTS, INC.
Rego Safe Mobility App
In Commercial Distribution

  • 00840828192095 ()


  • Inpatient motion surveillance software
Mobile App utilized in the PDM (Personal Device Manager) for Dash. Insulin pump secondary display. PDM Device 18239; app 41253
Insulet Corporation
1.3.1
In Commercial Distribution

  • 10385081120272 ()
18239

  • Ambulatory insulin infusion pump software, data-display
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