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 K243126

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
14063108100938 K243126 000
14063108101065 K243126 000
14063108101072 K243126 000
14063108101089 K243126 000
14063108101096 K243126 000
14063108101270 K243126 000
14063108101287 K243126 000
14063108101294 K243126 000
14063108101300 K243126 000
14063108101324 K243126 000
14063108101331 K243126 000
14063108101058 K243126 000
14063108101041 K243126 000
14063108100945 K243126 000
14063108100952 K243126 000
14063108100969 K243126 000
14063108100976 K243126 000
14063108100983 K243126 000
14063108100990 K243126 000
14063108101003 K243126 000
14063108101010 K243126 000
14063108101027 K243126 000
14063108101034 K243126 000
14063108101348 K243126 000
14063108101355 K243126 000
14063108101362 K243126 000
14063108101805 K243126 000
14063108101812 K243126 000
14063108101829 K243126 000
14063108101836 K243126 000
14063108101843 K243126 000
14063108101874 K243126 000
14063108101881 K243126 000
14063108101898 K243126 000
14063108101942 K243126 000
14063108101959 K243126 000
14063108101799 K243126 000
14063108101782 K243126 000
14063108101676 K243126 000
14063108101683 K243126 000
14063108101690 K243126 000
14063108101706 K243126 000
14063108101713 K243126 000
14063108101720 K243126 000
14063108101737 K243126 000
14063108101744 K243126 000
14063108101751 K243126 000
14063108101775 K243126 000
14063108101966 K243126 000
14063108100358 K243126 000
14063108100495 K243126 000
14063108100501 K243126 000
14063108100518 K243126 000
14063108100525 K243126 000
14063108100532 K243126 000
14063108100549 K243126 000
14063108100556 K243126 000
14063108100563 K243126 000
14063108100570 K243126 000
14063108100662 K243126 000
14063108100488 K243126 000
14063108100464 K243126 000
14063108100365 K243126 000
14063108100372 K243126 000
14063108100389 K243126 000
14063108100396 K243126 000
14063108100402 K243126 000
14063108100419 K243126 000
14063108100426 K243126 000
14063108100433 K243126 000
14063108100440 K243126 000
14063108100457 K243126 000
14063108100679 K243126 000
14063108100686 K243126 000
14063108100693 K243126 000
14063108100822 K243126 000
14063108100839 K243126 000
14063108100846 K243126 000
14063108100853 K243126 000
14063108100860 K243126 000
14063108100877 K243126 000
14063108100884 K243126 000
14063108100891 K243126 000
14063108100907 K243126 000
14063108100914 K243126 000
14063108100815 K243126 000
14063108100808 K243126 000
14063108100709 K243126 000
14063108100716 K243126 000
14063108100723 K243126 000
14063108100730 K243126 000
14063108100747 K243126 000
14063108100754 K243126 000
14063108100761 K243126 000
14063108100778 K243126 000
14063108100785 K243126 000
14063108100792 K243126 000
14063108100921 K243126 000
14063108101973 K243126 000
14063108100327 K243126 000
14063108101591 K243126 000
14063108101607 K243126 000
14063108101614 K243126 000
14063108101621 K243126 000
14063108101638 K243126 000
14063108101645 K243126 000
14063108101652 K243126 000
14063108101669 K243126 000
14063108106350 K243126 000
14063108108934 K243126 000
14063108101584 K243126 000
14063108101577 K243126 000
14063108100334 K243126 000
14063108100341 K243126 000
14063108101492 K243126 000
14063108101508 K243126 000
14063108101515 K243126 000
14063108101522 K243126 000
14063108101539 K243126 000
14063108101546 K243126 000
14063108101553 K243126 000
14063108101560 K243126 000
14063108100075 K243126 000
14063108100082 K243126 000
14063108100099 K243126 000
14063108101454 K243126 000
14063108101461 K243126 000
14063108101478 K243126 000
14063108108910 K243126 000
14063108108927 K243126 000
14063108100013 K243126 000
14063108100020 K243126 000
14063108100037 K243126 000
14063108100044 K243126 000
14063108100051 K243126 000
14063108101447 K243126 000
14063108101430 K243126 000
14063108100105 K243126 000
14063108100112 K243126 000
14063108100129 K243126 000
14063108100136 K243126 000
14063108101379 K243126 000
14063108101386 K243126 000
14063108101393 K243126 000
14063108101409 K243126 000
14063108101416 K243126 000
14063108101423 K243126 000
14063108100068 K243126 000
14063108101980 K243126 000
14063108102116 K243126 000
14063108102390 K243126 000
14063108102406 K243126 000
14063108102413 K243126 000
14063108102420 K243126 000
14063108102437 K243126 000
14063108107555 K243126 000
14063108108941 K243126 000
14063108108958 K243126 000
14063108108965 K243126 000
14063108102109 K243126 000
14063108102093 K243126 000
14063108101997 K243126 000
14063108102000 K243126 000
14063108102017 K243126 000
14063108102024 K243126 000
14063108102031 K243126 000
14063108102048 K243126 000
14063108102055 K243126 000
14063108102062 K243126 000
14063108102079 K243126 000
14063108102086 K243126 000
14063108108972 K243126 000
14063108108989 K243126 000
14063108108996 K243126 000
14063108100211 K243126 000
14063108100228 K243126 000
14063108100235 K243126 000
14063108100242 K243126 000
14063108100259 K243126 000
14063108100266 K243126 000
14063108100273 K243126 000
14063108100280 K243126 000
14063108100297 K243126 000
14063108100303 K243126 000
14063108100198 K243126 000
14063108100174 K243126 000
14063108109009 K243126 000
14063108109016 K243126 000
14063108109023 K243126 000
14063108109030 K243126 000
14063108109047 K243126 000
14063108109054 K243126 000
14063108109061 K243126 000
14063108109078 K243126 000
14063108100150 K243126 000
14063108100167 K243126 000
14063108100310 K243126 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


© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.