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 K230127

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
16932503514238 K230127 000
16932503514368 K230127 000
16932503514375 K230127 000
16932503514382 K230127 000
16932503514399 K230127 000
16932503514405 K230127 000
16932503514412 K230127 000
16932503514429 K230127 000
16932503514436 K230127 000
16932503514443 K230127 000
16932503514450 K230127 000
16932503514351 K230127 000
16932503514344 K230127 000
16932503514245 K230127 000
16932503514252 K230127 000
16932503514269 K230127 000
16932503514276 K230127 000
16932503514283 K230127 000
16932503514290 K230127 000
16932503514306 K230127 000
16932503514313 K230127 000
16932503514320 K230127 000
16932503514337 K230127 000
16932503514467 K230127 000
16932503514474 K230127 000
16932503514603 K230127 000
16932503514610 K230127 000
16932503514665 K230127 000
16932503514672 K230127 000
16932503514689 K230127 000
16932503514719 K230127 000
16932503514726 K230127 000
16932503514733 K230127 000
16932503514740 K230127 000
16932503514757 K230127 000
16932503514597 K230127 000
16932503514580 K230127 000
16932503514481 K230127 000
16932503514498 K230127 000
16932503514504 K230127 000
16932503514511 K230127 000
16932503514528 K230127 000
16932503514535 K230127 000
16932503514542 K230127 000
16932503514559 K230127 000
16932503514566 K230127 000
16932503514573 K230127 000
16932503514764 K230127 000
16932503513705 K230127 000
16932503513835 K230127 000
16932503513842 K230127 000
16932503513859 K230127 000
16932503513866 K230127 000
16932503513910 K230127 000
16932503513927 K230127 000
16932503513934 K230127 000
16932503513941 K230127 000
16932503513965 K230127 000
16932503513972 K230127 000
16932503513828 K230127 000
16932503513811 K230127 000
16932503513712 K230127 000
16932503513729 K230127 000
16932503513736 K230127 000
16932503513743 K230127 000
16932503513750 K230127 000
16932503513767 K230127 000
16932503513774 K230127 000
16932503513781 K230127 000
16932503513798 K230127 000
16932503513804 K230127 000
16932503513989 K230127 000
16932503513996 K230127 000
16932503514122 K230127 000
16932503514139 K230127 000
16932503514146 K230127 000
16932503514153 K230127 000
16932503514160 K230127 000
16932503514177 K230127 000
16932503514184 K230127 000
16932503514191 K230127 000
16932503514207 K230127 000
16932503514214 K230127 000
16932503514115 K230127 000
16932503514108 K230127 000
16932503514009 K230127 000
16932503514016 K230127 000
16932503514023 K230127 000
16932503514030 K230127 000
16932503514047 K230127 000
16932503514054 K230127 000
16932503514061 K230127 000
16932503514078 K230127 000
16932503514085 K230127 000
16932503514092 K230127 000
16932503514221 K230127 000
16932503514771 K230127 000
16932503513224 K230127 000
16932503513354 K230127 000
16932503513361 K230127 000
16932503513378 K230127 000
16932503513385 K230127 000
16932503513392 K230127 000
16932503513408 K230127 000
16932503513415 K230127 000
16932503513422 K230127 000
16932503513439 K230127 000
16932503513446 K230127 000
16932503513347 K230127 000
16932503513330 K230127 000
16932503513231 K230127 000
16932503513248 K230127 000
16932503513255 K230127 000
16932503513262 K230127 000
16932503513279 K230127 000
16932503513286 K230127 000
16932503513293 K230127 000
16932503513309 K230127 000
16932503513316 K230127 000
16932503513323 K230127 000
16932503513453 K230127 000
16932503513460 K230127 000
16932503513590 K230127 000
16932503513606 K230127 000
16932503513613 K230127 000
16932503513620 K230127 000
16932503513637 K230127 000
16932503513644 K230127 000
16932503513651 K230127 000
16932503513668 K230127 000
16932503513675 K230127 000
16932503513682 K230127 000
16932503513583 K230127 000
16932503513576 K230127 000
16932503513477 K230127 000
16932503513484 K230127 000
16932503513491 K230127 000
16932503513507 K230127 000
16932503513514 K230127 000
16932503513521 K230127 000
16932503513538 K230127 000
16932503513545 K230127 000
16932503513552 K230127 000
16932503513569 K230127 000
16932503513699 K230127 000
16932503514788 K230127 000
16932503514917 K230127 000
16932503514924 K230127 000
16932503514931 K230127 000
16932503514948 K230127 000
16932503514955 K230127 000
16932503514962 K230127 000
16932503514979 K230127 000
16932503514986 K230127 000
16932503514993 K230127 000
16932503515006 K230127 000
16932503514900 K230127 000
16932503514894 K230127 000
16932503514795 K230127 000
16932503514801 K230127 000
16932503514818 K230127 000
16932503514825 K230127 000
16932503514832 K230127 000
16932503514849 K230127 000
16932503514856 K230127 000
16932503514863 K230127 000
16932503514870 K230127 000
16932503514887 K230127 000
16932503515013 K230127 000
16932503515020 K230127 000
16932503515150 K230127 000
16932503515167 K230127 000
16932503515174 K230127 000
16932503515181 K230127 000
16932503515198 K230127 000
16932503515204 K230127 000
16932503515211 K230127 000
16932503515228 K230127 000
16932503515235 K230127 000
16932503515242 K230127 000
16932503515143 K230127 000
16932503515136 K230127 000
16932503515037 K230127 000
16932503515044 K230127 000
16932503515051 K230127 000
16932503515068 K230127 000
16932503515075 K230127 000
16932503515082 K230127 000
16932503515099 K230127 000
16932503515105 K230127 000
16932503515112 K230127 000
16932503515129 K230127 000
16932503513217 K230127 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.