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 K230126

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
08806169108142 K230126 000
08800053084703 K230126 000
08800053084710 K230126 000
08806169106223 K230126 000
08806169106230 K230126 000
08806169106247 K230126 000
08806169106254 K230126 000
08806169106308 K230126 000
08806169106315 K230126 000
08800053084697 K230126 000
08800053084680 K230126 000
08800053084604 K230126 000
08800053084611 K230126 000
08800053084628 K230126 000
08800053084635 K230126 000
08800053084642 K230126 000
08800053084659 K230126 000
08800053084666 K230126 000
08800053084673 K230126 000
08806169106322 K230126 000
08806169106339 K230126 000
08806169107886 K230126 000
08806169107893 K230126 000
08806169107909 K230126 000
08806169107916 K230126 000
08806169107923 K230126 000
08806169107930 K230126 000
08806169107947 K230126 000
08806169108135 K230126 000
08806169107879 K230126 000
08806169107862 K230126 000
08806169106346 K230126 000
08806169106353 K230126 000
08806169106360 K230126 000
08806169106377 K230126 000
08806169107824 K230126 000
08806169107831 K230126 000
08806169107848 K230126 000
08806169107855 K230126 000
08800053084598 K230126 000
08800053084581 K230126 000
08800053084574 K230126 000
08800053012225 K230126 000
08800053012232 K230126 000
08800053012249 K230126 000
08800053012256 K230126 000
08800053012287 K230126 000
08800053012294 K230126 000
08800053012300 K230126 000
08800053012317 K230126 000
08806169134387 K230126 000
08806169134363 K230126 000
08800053000055 K230126 000
08800053000048 K230126 000
08800053084727 K230126 000
08800053084734 K230126 000
08800053084741 K230126 000
08800053084758 K230126 000
08800053084765 K230126 000
08806169131492 K230126 000
08800053012348 K230126 000
08800053012355 K230126 000
08800053084482 K230126 000
08800053084499 K230126 000
08800053084505 K230126 000
08800053084529 K230126 000
08800053084536 K230126 000
08800053084543 K230126 000
08800053084550 K230126 000
08800053084567 K230126 000
08800053084475 K230126 000
08800053084468 K230126 000
08800053012362 K230126 000
08800053012379 K230126 000
08800053012409 K230126 000
08800053012416 K230126 000
08800053012423 K230126 000
08800053012430 K230126 000
08800053084444 K230126 000
08800053084451 K230126 000
08806169186058 K230126 000
08806169108159 K230126 000
08806169191724 K230126 000
08806169170576 K230126 000
08806169170583 K230126 000
08806169170590 K230126 000
08806169170606 K230126 000
08806169172112 K230126 000
08806169172129 K230126 000
08806169172136 K230126 000
08806169172143 K230126 000
08806169170569 K230126 000
08806169170552 K230126 000
08806169170477 K230126 000
08806169170484 K230126 000
08806169170491 K230126 000
08806169170507 K230126 000
08806169170514 K230126 000
08806169170521 K230126 000
08806169170538 K230126 000
08806169170545 K230126 000
08806169172198 K230126 000
08806169172204 K230126 000
08806169172518 K230126 000
08806169172525 K230126 000
08806169172532 K230126 000
08806169172549 K230126 000
08806169172556 K230126 000
08806169172563 K230126 000
08806169172570 K230126 000
08806169172587 K230126 000
08806169172464 K230126 000
08806169172457 K230126 000
08806169172211 K230126 000
08806169172228 K230126 000
08806169172235 K230126 000
08806169172242 K230126 000
08806169172259 K230126 000
08806169172266 K230126 000
08806169172433 K230126 000
08806169172440 K230126 000
08806169154422 K230126 000
08806169154415 K230126 000
08806169154408 K230126 000
08806169108272 K230126 000
08806169108289 K230126 000
08806169108296 K230126 000
08806169108302 K230126 000
08806169108517 K230126 000
08806169108524 K230126 000
08806169108531 K230126 000
08806169108548 K230126 000
08806169108265 K230126 000
08806169108258 K230126 000
08806169108173 K230126 000
08806169108180 K230126 000
08806169108197 K230126 000
08806169108203 K230126 000
08806169108210 K230126 000
08806169108227 K230126 000
08806169108234 K230126 000
08806169108241 K230126 000
08806169108555 K230126 000
08806169108562 K230126 000
08806169147844 K230126 000
08806169147851 K230126 000
08806169147868 K230126 000
08806169147875 K230126 000
08806169147882 K230126 000
08806169147899 K230126 000
08806169147905 K230126 000
08806169147912 K230126 000
08806169147790 K230126 000
08806169147783 K230126 000
08806169108579 K230126 000
08806169108586 K230126 000
08806169108593 K230126 000
08806169108609 K230126 000
08806169108616 K230126 000
08806169111821 K230126 000
08806169147769 K230126 000
08806169147776 K230126 000
08806169108166 K230126 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


© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.