A PHP Error was encountered

Severity: Notice

Message: Undefined index: pmaNumber

Filename: fda.report/pmn_item.php

Line Number: 21

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 21
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

Line Number: 25

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 25
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicant

Filename: fda.report/pmn_item.php

Line Number: 25

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 25
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

Line Number: 26

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 26
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicant

Filename: fda.report/pmn_item.php

Line Number: 26

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 26
Function: _error_handler

510(k) FDA Premarket Notification K252322

A PHP Error was encountered

Severity: Notice

Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

Line Number: 33

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 33
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: classificationName

Filename: fda.report/pmn_item.php

Line Number: 34

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 34
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicant

Filename: fda.report/pmn_item.php

Line Number: 35

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 35
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicant

Filename: fda.report/pmn_item.php

Line Number: 54

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 54
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicant

Filename: fda.report/pmn_item.php

Line Number: 55

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 55
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicant

Filename: fda.report/pmn_item.php

Line Number: 66

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 66
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

Line Number: 66

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 66
Function: _error_handler

The following data is part of a premarket notification filed by with the FDA for .

Pre-market Notification Details

A PHP Error was encountered

Severity: Notice

Message: Undefined index: deviceId

Filename: fda.report/pmn_item.php

Line Number: 78

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 78
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: 501kNumber

Filename: fda.report/pmn_item.php

Line Number: 79

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 79
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

Line Number: 80

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 80
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: classificationName

Filename: fda.report/pmn_item.php

Line Number: 81

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 81
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicantFull

Filename: fda.report/pmn_item.php

Line Number: 82

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 82
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicantContact

Filename: fda.report/pmn_item.php

Line Number: 83

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 83
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicantContact

Filename: fda.report/pmn_item.php

Line Number: 83

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 83
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: correspondent

Filename: fda.report/pmn_item.php

Line Number: 84

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 84
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: correspondentContact

Filename: fda.report/pmn_item.php

Line Number: 84

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 84
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: correspondentContact

Filename: fda.report/pmn_item.php

Line Number: 85

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 85
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: correspondent

Filename: fda.report/pmn_item.php

Line Number: 85

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 85
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: classificationPC

Filename: fda.report/pmn_item.php

Line Number: 87

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 87
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: subsequentPC

Filename: fda.report/pmn_item.php

Line Number: 90

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 90
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: regulationNumber

Filename: fda.report/pmn_item.php

Line Number: 95

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 95
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: decision

Filename: fda.report/pmn_item.php

Line Number: 99

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 99
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: regulationMS

Filename: fda.report/pmn_item.php

Line Number: 100

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 100
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: 501kReviewPanel

Filename: fda.report/pmn_item.php

Line Number: 103

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 103
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: fdaReview

Filename: fda.report/pmn_item.php

Line Number: 106

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 106
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: fdaReview

Filename: fda.report/pmn_item.php

Line Number: 107

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 107
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: type

Filename: fda.report/pmn_item.php

Line Number: 109

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 109
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: thirdPartyReviewed

Filename: fda.report/pmn_item.php

Line Number: 110

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 110
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: combinationProduct

Filename: fda.report/pmn_item.php

Line Number: 111

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 111
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: dateReceived

Filename: fda.report/pmn_item.php

Line Number: 112

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 112
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: decisionDate

Filename: fda.report/pmn_item.php

Line Number: 113

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 113
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: summary

Filename: fda.report/pmn_item.php

Line Number: 114

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 114
Function: _error_handler

Correspondent

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M719GSIXC1151000 K252322 000
M719GSIXFM1051100 K252322 000
M719GSIXFM1051000 K252322 000
M719GSIXFM1050900 K252322 000
M719GSIXFM1050800 K252322 000
M719GSIXFM1050700 K252322 000
M719GSIXFM1050600 K252322 000
M719GSIXFM1050500 K252322 000
M719GSIXFM1050400 K252322 000
M719GSIXFM0951400 K252322 000
M719GSIXFM0951300 K252322 000
M719GSIXFM0951200 K252322 000
M719GSIXFM0951100 K252322 000
M719GSIXFM0951000 K252322 000
M719GSIXFM1051200 K252322 000
M719GSIXFM1051300 K252322 000
M719GSIXFM1051400 K252322 000
M719GSIXC1150900 K252322 000
M719GSIXC1150800 K252322 000
M719GSIXC1150700 K252322 000
M719GSIXC1150600 K252322 000
M719GSIXC1150500 K252322 000
M719GSIXC1150400 K252322 000
M719GSIXC1051400 K252322 000
M719GSIXC1051300 K252322 000
M719GSIXC1051200 K252322 000
M719GSIXC1051100 K252322 000
M719GSIXFM1150600 K252322 000
M719GSIXFM1150500 K252322 000
M719GSIXFM1150400 K252322 000
M719GSIXFM0950900 K252322 000
M719GSIXFM0950800 K252322 000
M719GSIXFL1051300 K252322 000
M719GSIXFL1051200 K252322 000
M719GSIXFL1051100 K252322 000
M719GSIXFL1051000 K252322 000
M719GSIXFL1050900 K252322 000
M719GSIXFL1050800 K252322 000
M719GSIXFL1050700 K252322 000
M719GSIXFL1050600 K252322 000
M719GSIXFL1050500 K252322 000
M719GSIXFL1050400 K252322 000
M719GSIXFL0951400 K252322 000
M719GSIXFL0951300 K252322 000
M719GSIXFL0951200 K252322 000
M719GSIXFL1051400 K252322 000
M719GSIXFL1150400 K252322 000
M719GSIXFL1150500 K252322 000
M719GSIXFM0950700 K252322 000
M719GSIXFM0950600 K252322 000
M719GSIXFM0950500 K252322 000
M719GSIXFM0950400 K252322 000
M719GSIXFL1151400 K252322 000
M719GSIXFL1151300 K252322 000
M719GSIXFL1151200 K252322 000
M719GSIXFL1151100 K252322 000
M719GSIXFL1151000 K252322 000
M719GSIXFL1150900 K252322 000
M719GSIXFL1150800 K252322 000
M719GSIXFL1150700 K252322 000
M719GSIXFL1150600 K252322 000
M719GSIXFL0951100 K252322 000
M719GSIXC1051000 K252322 000
M719GSIXC0950400 K252322 000
M719GSIXFL0951000 K252322 000
M719GSIXFL0950900 K252322 000
M719GSIXFL0950800 K252322 000
M719GSIXFL0950700 K252322 000
M719GSIXFL0950600 K252322 000
M719GSIXFL0950500 K252322 000
M719GSIXFL0950400 K252322 000
M719GSIXFC1151400 K252322 000
M719GSIXFC1151300 K252322 000
M719GSIXFC1151200 K252322 000
M719GSIXFC1151100 K252322 000
M719GSIXFC1151000 K252322 000
M719GSIXC0950500 K252322 000
M719GSIXC0950600 K252322 000
M719GSIXC0950700 K252322 000
M719GSIXC1050900 K252322 000
M719GSIXC1050800 K252322 000
M719GSIXC1050700 K252322 000
M719GSIXC1050600 K252322 000
M719GSIXC1050500 K252322 000
M719GSIXC1050400 K252322 000
M719GSIXC0951400 K252322 000
M719GSIXC0951300 K252322 000
M719GSIXC0951200 K252322 000
M719GSIXC0951100 K252322 000
M719GSIXC0951000 K252322 000
M719GSIXC0950900 K252322 000
M719GSIXC0950800 K252322 000
M719GSIXFC1150900 K252322 000
M719GSIXFC1150800 K252322 000
M719GSIXFC0951300 K252322 000
M719GSIXFC0951200 K252322 000
M719GSIXFC0951100 K252322 000
M719GSIXFC0951000 K252322 000
M719GSIXFC0950900 K252322 000
M719GSIXFC0950800 K252322 000
M719GSIXFC0950700 K252322 000
M719GSIXFC0950600 K252322 000
M719GSIXFC0950500 K252322 000
M719GSIXFC0950400 K252322 000
M719GSIXC1151400 K252322 000
M719GSIXC1151300 K252322 000
M719GSIXC1151200 K252322 000
M719GSIXFC0951400 K252322 000
M719GSIXFC1050400 K252322 000
M719GSIXFC1050500 K252322 000
M719GSIXFC1150700 K252322 000
M719GSIXFC1150600 K252322 000
M719GSIXFC1150500 K252322 000
M719GSIXFC1150400 K252322 000
M719GSIXFC1051400 K252322 000
M719GSIXFC1051300 K252322 000
M719GSIXFC1051200 K252322 000
M719GSIXFC1051100 K252322 000
M719GSIXFC1051000 K252322 000
M719GSIXFC1050900 K252322 000
M719GSIXFC1050800 K252322 000
M719GSIXFC1050700 K252322 000
M719GSIXFC1050600 K252322 000
M719GSIXC1151100 K252322 000

A PHP Error was encountered

Severity: Notice

Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

Line Number: 156

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 156
Function: _error_handler


© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.