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 Class Implantable

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Waterproof Bed Sheet (Twin XL)
VIVE HEALTH LLC
LVA1058TWNXL
In Commercial Distribution

  • 00818323025521 ()


  • Waterproof bed mattress cover, reusable
Waterproof Bed Sheet (Twin XL) 2PK
VIVE HEALTH LLC
LVA1058TWNXL2
In Commercial Distribution

  • 00818323025514 ()


  • Waterproof bed mattress cover, reusable
Waterproof Bed Sheet (California King) 2PK
VIVE HEALTH LLC
LVA1058CKNG2
In Commercial Distribution

  • 00818323025507 ()


  • Waterproof bed mattress cover, reusable
Waterproof Bed Sheet (California King)
VIVE HEALTH LLC
LVA1058CKNG
In Commercial Distribution

  • 00818323025491 ()


  • Waterproof bed mattress cover, reusable
Waterproof Bed Sheet (King) 2PK
VIVE HEALTH LLC
LVA1058KNG2
In Commercial Distribution

  • 00818323024265 ()


  • Waterproof bed mattress cover, reusable
Waterproof Bed Sheet (Queen) 2PK
VIVE HEALTH LLC
LVA1058QUE2
In Commercial Distribution

  • 00818323024258 ()


  • Waterproof bed mattress cover, reusable
Waterproof Bed Sheet (Full) 2PK
VIVE HEALTH LLC
LVA1058FUL2
In Commercial Distribution

  • 00818323024241 ()


  • Waterproof bed mattress cover, reusable
Waterproof Bed Sheet (Twin) 2PK
VIVE HEALTH LLC
LVA1058TWN2
In Commercial Distribution

  • 00818323024234 ()


  • Waterproof bed mattress cover, reusable
Waterproof Bed Sheet (King)
VIVE HEALTH LLC
LVA1058KNG
In Commercial Distribution

  • 00818323020434 ()


  • Waterproof bed mattress cover, reusable
Waterproof Bed Sheet (Queen)
VIVE HEALTH LLC
LVA1058QUE
In Commercial Distribution

  • 00818323020427 ()


  • Waterproof bed mattress cover, reusable
Waterproof Bed Sheet (Full)
VIVE HEALTH LLC
LVA1058FUL
In Commercial Distribution

  • 00818323020410 ()


  • Waterproof bed mattress cover, reusable
Waterproof Bed Sheet (Twin)
VIVE HEALTH LLC
LVA1058TWN
In Commercial Distribution

  • 00818323020403 ()


  • Waterproof bed mattress cover, reusable
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
Also covers the following minor/medium updates: v3.1.0 (01)00860001471724(11)210526(10)310; v3.1.1 (01)00860001471724(11)210604(10)311; v3.1.2 (01)00860001471724(11)210625(10)312; v3.2.0 (01)00860001471724(11)210713(10)320; v3.2.1. (01)00860001471724(11)210804(10)321; v3.2.2 (01)00860001471724(11)210917(10)322; v3.2.3 (01)00860001471724(11)211026(10)323 ;v3.2.4 (01)00860001471724(11)211123(10)324; v3.7.0 (01)00860001471724(11) 221116(10)370; v3.6.2 (01)00860001471724(11) 221024(10)362; v3.4.0:(01)00860001471724(11)220609(10)350; v3.5.1(01)00860001471724(11)220718(10)351; v3.6.0 (01)00860001471724(11) 220926(10)360; v3.8.0 (01)00860001471724(11) 221215(10)380; v3.8.1 (01)00860001471724(11) 230127(10)381; v3.9.0 (01)00860001471724(11) 230217(10)390; v3.9.1 (01)00860001471724(11) 230417(10)391; v3.9.2 (01)00860001471724(11) 230609(10)392; v3.9.3 (01)00860001471724(11) 230714(10)393; v3.10.0 (01)00860001471724(11) 231013(10)3100
AMPLIFON SPA
iOS v3
In Commercial Distribution

  • 00860001471724 ()


  • Hearing aid/implant system remote control
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
No Description
Clarius Mobile Health Corp
App - iOS
In Commercial Distribution

  • 07540205000397 ()
12-01-00003

  • Ultrasound imaging system application software
  • Radiological PACS software
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