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 K241375

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
00190376655734 K241375 000
00190376655918 K241375 000
00190376655925 K241375 000
00190376655932 K241375 000
00190376655949 K241375 000
00190376655956 K241375 000
00190376655963 K241375 000
00190376655970 K241375 000
00190376655987 K241375 000
00190376655994 K241375 000
00190376656007 K241375 000
00190376656014 K241375 000
00190376656021 K241375 000
00190376656038 K241375 000
00190376656045 K241375 000
00190376655901 K241375 000
00190376655895 K241375 000
00190376655888 K241375 000
00190376655741 K241375 000
00190376655758 K241375 000
00190376655765 K241375 000
00190376655772 K241375 000
00190376655789 K241375 000
00190376655796 K241375 000
00190376655802 K241375 000
00190376655819 K241375 000
00190376655826 K241375 000
00190376655833 K241375 000
00190376655840 K241375 000
00190376655857 K241375 000
00190376655864 K241375 000
00190376655871 K241375 000
00190376656052 K241375 000
00190376656069 K241375 000
00190376656076 K241375 000
00190376656250 K241375 000
00190376656267 K241375 000
00190376656274 K241375 000
00190376656281 K241375 000
00190376656298 K241375 000
00190376656304 K241375 000
00190376656311 K241375 000
00190376656328 K241375 000
00190376656335 K241375 000
00190376656342 K241375 000
00190376656359 K241375 000
00190376656366 K241375 000
00190376656373 K241375 000
00190376656380 K241375 000
00190376656243 K241375 000
00190376656236 K241375 000
00190376656229 K241375 000
00190376656083 K241375 000
00190376656090 K241375 000
00190376656106 K241375 000
00190376656113 K241375 000
00190376656120 K241375 000
00190376656137 K241375 000
00190376656144 K241375 000
00190376656151 K241375 000
00190376656168 K241375 000
00190376656175 K241375 000
00190376656182 K241375 000
00190376656199 K241375 000
00190376656205 K241375 000
00190376656212 K241375 000
00190376656397 K241375 000
00190376655727 K241375 000
00190376655055 K241375 000
00190376655239 K241375 000
00190376655246 K241375 000
00190376655253 K241375 000
00190376655260 K241375 000
00190376655277 K241375 000
00190376655284 K241375 000
00190376655291 K241375 000
00190376655307 K241375 000
00190376655314 K241375 000
00190376655321 K241375 000
00190376655338 K241375 000
00190376655345 K241375 000
00190376655352 K241375 000
00190376655369 K241375 000
00190376655222 K241375 000
00190376655215 K241375 000
00190376655208 K241375 000
00190376655062 K241375 000
00190376655079 K241375 000
00190376655086 K241375 000
00190376655093 K241375 000
00190376655109 K241375 000
00190376655116 K241375 000
00190376655123 K241375 000
00190376655130 K241375 000
00190376655147 K241375 000
00190376655154 K241375 000
00190376655161 K241375 000
00190376655178 K241375 000
00190376655185 K241375 000
00190376655192 K241375 000
00190376655376 K241375 000
00190376655383 K241375 000
00190376655390 K241375 000
00190376655574 K241375 000
00190376655581 K241375 000
00190376655598 K241375 000
00190376655604 K241375 000
00190376655611 K241375 000
00190376655628 K241375 000
00190376655635 K241375 000
00190376655642 K241375 000
00190376655659 K241375 000
00190376655666 K241375 000
00190376655673 K241375 000
00190376655680 K241375 000
00190376655697 K241375 000
00190376655703 K241375 000
00190376655567 K241375 000
00190376655550 K241375 000
00190376655543 K241375 000
00190376655406 K241375 000
00190376655413 K241375 000
00190376655420 K241375 000
00190376655437 K241375 000
00190376655444 K241375 000
00190376655451 K241375 000
00190376655468 K241375 000
00190376655475 K241375 000
00190376655482 K241375 000
00190376655499 K241375 000
00190376655505 K241375 000
00190376655512 K241375 000
00190376655529 K241375 000
00190376655536 K241375 000
00190376655710 K241375 000
00190376666655 K241375 000
00190376566696 K241375 000
00190376566702 K241375 000
00190376566719 K241375 000
00190376566726 K241375 000
00190376566733 K241375 000
00190376566740 K241375 000
00190376566757 K241375 000
00190376566764 K241375 000
00190376566771 K241375 000
00190376566788 K241375 000
00190376566795 K241375 000
00190376566801 K241375 000
00190376566818 K241375 000
00190376566825 K241375 000
00190376566689 K241375 000
00190376566672 K241375 000
00190376566665 K241375 000
00190376666662 K241375 000
00190376666679 K241375 000
00190376666686 K241375 000
00190376666693 K241375 000
00190376666709 K241375 000
00190376666716 K241375 000
00190376666723 K241375 000
00190376180441 K241375 000
00190376180540 K241375 000
00190376182117 K241375 000
00190376566627 K241375 000
00190376566634 K241375 000
00190376566641 K241375 000
00190376566658 K241375 000
00190376566832 K241375 000
00190376566849 K241375 000
00190376566856 K241375 000
00190376567037 K241375 000
00190376567044 K241375 000
00190376567051 K241375 000
00190376567068 K241375 000
00190376567075 K241375 000
00190376567082 K241375 000
00190376567099 K241375 000
00190376567105 K241375 000
00190376567112 K241375 000
00190376567129 K241375 000
00190376567136 K241375 000
00190376567143 K241375 000
00190376567150 K241375 000
00190376567167 K241375 000
00190376567020 K241375 000
00190376567013 K241375 000
00190376567006 K241375 000
00190376566863 K241375 000
00190376566870 K241375 000
00190376566887 K241375 000
00190376566894 K241375 000
00190376566900 K241375 000
00190376566917 K241375 000
00190376566924 K241375 000
00190376566931 K241375 000
00190376566948 K241375 000
00190376566955 K241375 000
00190376566962 K241375 000
00190376566979 K241375 000
00190376566986 K241375 000
00190376566993 K241375 000
00190376567464 K241375 000
00190376666648 K241375 000
00190376656403 K241375 000
00190376656588 K241375 000
00190376656595 K241375 000
00190376656601 K241375 000
00190376656618 K241375 000
00190376656625 K241375 000
00190376656632 K241375 000
00190376656649 K241375 000
00190376656656 K241375 000
00190376656663 K241375 000
00190376656670 K241375 000
00190376656687 K241375 000
00190376656694 K241375 000
00190376656700 K241375 000
00190376656717 K241375 000
00190376656571 K241375 000
00190376656564 K241375 000
00190376656557 K241375 000
00190376656410 K241375 000
00190376656427 K241375 000
00190376656434 K241375 000
00190376656441 K241375 000
00190376656458 K241375 000
00190376656465 K241375 000
00190376656472 K241375 000
00190376656489 K241375 000
00190376656496 K241375 000
00190376656502 K241375 000
00190376656519 K241375 000
00190376656526 K241375 000
00190376656533 K241375 000
00190376656540 K241375 000
00190376656724 K241375 000
00190376656731 K241375 000
00190376656748 K241375 000
00190376666495 K241375 000
00190376666501 K241375 000
00190376666518 K241375 000
00190376666525 K241375 000
00190376666532 K241375 000
00190376666549 K241375 000
00190376666556 K241375 000
00190376666563 K241375 000
00190376666570 K241375 000
00190376666587 K241375 000
00190376666594 K241375 000
00190376666600 K241375 000
00190376666617 K241375 000
00190376666624 K241375 000
00190376666488 K241375 000
00190376666471 K241375 000
00190376666464 K241375 000
00190376656755 K241375 000
00190376656762 K241375 000
00190376656779 K241375 000
00190376656786 K241375 000
00190376656793 K241375 000
00190376656809 K241375 000
00190376666389 K241375 000
00190376666396 K241375 000
00190376666402 K241375 000
00190376666419 K241375 000
00190376666426 K241375 000
00190376666433 K241375 000
00190376666440 K241375 000
00190376666457 K241375 000
00190376666631 K241375 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.