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 K233509

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
00197157026189 K233509 000
00197157026042 K233509 000
00197157026035 K233509 000
00197157026028 K233509 000
00197157026011 K233509 000
00197157026004 K233509 000
00197157025991 K233509 000
00197157025984 K233509 000
00197157025977 K233509 000
00197157025960 K233509 000
00197157025953 K233509 000
00197157026059 K233509 000
00197157026066 K233509 000
00197157026073 K233509 000
00197157026172 K233509 000
00197157026165 K233509 000
00197157026158 K233509 000
00197157026141 K233509 000
00197157026134 K233509 000
00197157026127 K233509 000
00197157026110 K233509 000
00197157026103 K233509 000
00197157026097 K233509 000
00197157026080 K233509 000
00197157025946 K233509 000
00197157025939 K233509 000
00197157025922 K233509 000
00197157025786 K233509 000
00197157025779 K233509 000
00197157025762 K233509 000
00197157025755 K233509 000
00197157025748 K233509 000
00197157068578 K233509 000
00197157068561 K233509 000
00197157068554 K233509 000
00197157068547 K233509 000
00197157068530 K233509 000
00197157025793 K233509 000
00197157025809 K233509 000
00197157025816 K233509 000
00197157025915 K233509 000
00197157025908 K233509 000
00197157025892 K233509 000
00197157025885 K233509 000
00197157025878 K233509 000
00197157025861 K233509 000
00197157025854 K233509 000
00197157025847 K233509 000
00197157025830 K233509 000
00197157025823 K233509 000
00197157068523 K233509 000
00197157040826 K233509 000
00197157026554 K233509 000
00197157026547 K233509 000
00197157026530 K233509 000
00197157026523 K233509 000
00197157026516 K233509 000
00197157026509 K233509 000
00197157026493 K233509 000
00197157026486 K233509 000
00197157026479 K233509 000
00197157026462 K233509 000
00197157026561 K233509 000
00197157026578 K233509 000
00197157026585 K233509 000
00197157040819 K233509 000
00197157040802 K233509 000
00197157040796 K233509 000
00197157040789 K233509 000
00197157040772 K233509 000
00197157040765 K233509 000
00197157040758 K233509 000
00197157040741 K233509 000
00197157040734 K233509 000
00197157026592 K233509 000
00197157026455 K233509 000
00197157026448 K233509 000
00197157026431 K233509 000
00197157026295 K233509 000
00197157026288 K233509 000
00197157026271 K233509 000
00197157026264 K233509 000
00197157026257 K233509 000
00197157026240 K233509 000
00197157026233 K233509 000
00197157026226 K233509 000
00197157026219 K233509 000
00197157026202 K233509 000
00197157026301 K233509 000
00197157026318 K233509 000
00197157026325 K233509 000
00197157026424 K233509 000
00197157026417 K233509 000
00197157026400 K233509 000
00197157026394 K233509 000
00197157026387 K233509 000
00197157026370 K233509 000
00197157026363 K233509 000
00197157026356 K233509 000
00197157026349 K233509 000
00197157026332 K233509 000
00197157026196 K233509 000
00197157068516 K233509 000
00197157069087 K233509 000
00197157068943 K233509 000
00197157068936 K233509 000
00197157068929 K233509 000
00197157068912 K233509 000
00197157068905 K233509 000
00197157068899 K233509 000
00197157068882 K233509 000
00197157068875 K233509 000
00197157068868 K233509 000
00197157068851 K233509 000
00197157068950 K233509 000
00197157068967 K233509 000
00197157068974 K233509 000
00197157069070 K233509 000
00197157069063 K233509 000
00197157069056 K233509 000
00197157069049 K233509 000
00197157069032 K233509 000
00197157069025 K233509 000
00197157069018 K233509 000
00197157069001 K233509 000
00197157068998 K233509 000
00197157068981 K233509 000
00197157068844 K233509 000
00197157068837 K233509 000
00197157068820 K233509 000
00197157068684 K233509 000
00197157068677 K233509 000
00197157068660 K233509 000
00197157068653 K233509 000
00197157068646 K233509 000
00197157068639 K233509 000
00197157068622 K233509 000
00197157068615 K233509 000
00197157068608 K233509 000
00197157068592 K233509 000
00197157068691 K233509 000
00197157068707 K233509 000
00197157068714 K233509 000
00197157068813 K233509 000
00197157068806 K233509 000
00197157068790 K233509 000
00197157068783 K233509 000
00197157068776 K233509 000
00197157068769 K233509 000
00197157068752 K233509 000
00197157068745 K233509 000
00197157068738 K233509 000
00197157068721 K233509 000
00197157068585 K233509 000
00197157068509 K233509 000
00197157069452 K233509 000
00197157069445 K233509 000
00197157069438 K233509 000
00197157069421 K233509 000
00197157069414 K233509 000
00197157069407 K233509 000
00197157069391 K233509 000
00197157069384 K233509 000
00197157069377 K233509 000
00197157069360 K233509 000
00197157069469 K233509 000
00197157069476 K233509 000
00197157069483 K233509 000
00197157069582 K233509 000
00197157069575 K233509 000
00197157069568 K233509 000
00197157069551 K233509 000
00197157069544 K233509 000
00197157069537 K233509 000
00197157069520 K233509 000
00197157069513 K233509 000
00197157069506 K233509 000
00197157069490 K233509 000
00197157069353 K233509 000
00197157069346 K233509 000
00197157069339 K233509 000
00197157069193 K233509 000
00197157069186 K233509 000
00197157069179 K233509 000
00197157069162 K233509 000
00197157069155 K233509 000
00197157069148 K233509 000
00197157069131 K233509 000
00197157069124 K233509 000
00197157069117 K233509 000
00197157069100 K233509 000
00197157069209 K233509 000
00197157069216 K233509 000
00197157069223 K233509 000
00197157069322 K233509 000
00197157069315 K233509 000
00197157069308 K233509 000
00197157069292 K233509 000
00197157069285 K233509 000
00197157069278 K233509 000
00197157069261 K233509 000
00197157069254 K233509 000
00197157069247 K233509 000
00197157069230 K233509 000
00197157069094 K233509 000
00197157039165 K233509 000
00197157039943 K233509 000
00197157039936 K233509 000
00197157039929 K233509 000
00197157039912 K233509 000
00197157039905 K233509 000
00197157039899 K233509 000
00197157039882 K233509 000
00197157039875 K233509 000
00197157039868 K233509 000
00197157039851 K233509 000
00197157039950 K233509 000
00197157039967 K233509 000
00197157039042 K233509 000
00197157039158 K233509 000
00197157039141 K233509 000
00197157039134 K233509 000
00197157039127 K233509 000
00197157039110 K233509 000
00197157039103 K233509 000
00197157039097 K233509 000
00197157039073 K233509 000
00197157039066 K233509 000
00197157039059 K233509 000
00197157039844 K233509 000
00197157039837 K233509 000
00197157039820 K233509 000
00197157039684 K233509 000
00197157040727 K233509 000
00197157040710 K233509 000
00197157040703 K233509 000
00197157040697 K233509 000
00197157040680 K233509 000
00197157040673 K233509 000
00197157040666 K233509 000
00197157040659 K233509 000
00197157040642 K233509 000
00197157039691 K233509 000
00197157039707 K233509 000
00197157039714 K233509 000
00197157039813 K233509 000
00197157039806 K233509 000
00197157039790 K233509 000
00197157039783 K233509 000
00197157039776 K233509 000
00197157039769 K233509 000
00197157039752 K233509 000
00197157039745 K233509 000
00197157039738 K233509 000
00197157039721 K233509 000
00197157040635 K233509 000
00197157039677 K233509 000
00197157039530 K233509 000
00197157039523 K233509 000
00197157039516 K233509 000
00197157039509 K233509 000
00197157039493 K233509 000
00197157039486 K233509 000
00197157039479 K233509 000
00197157039462 K233509 000
00197157039455 K233509 000
00197157039448 K233509 000
00197157039547 K233509 000
00197157039554 K233509 000
00197157039561 K233509 000
00197157039660 K233509 000
00197157039653 K233509 000
00197157039646 K233509 000
00197157039639 K233509 000
00197157039622 K233509 000
00197157039615 K233509 000
00197157039608 K233509 000
00197157039592 K233509 000
00197157039585 K233509 000
00197157039578 K233509 000
00197157039431 K233509 000
00197157039424 K233509 000
00197157039417 K233509 000
00197157039271 K233509 000
00197157039264 K233509 000
00197157039257 K233509 000
00197157039240 K233509 000
00197157039233 K233509 000
00197157039226 K233509 000
00197157039219 K233509 000
00197157039202 K233509 000
00197157039196 K233509 000
00197157039189 K233509 000
00197157039288 K233509 000
00197157039295 K233509 000
00197157039301 K233509 000
00197157039400 K233509 000
00197157039394 K233509 000
00197157039387 K233509 000
00197157039370 K233509 000
00197157039363 K233509 000
00197157039356 K233509 000
00197157039349 K233509 000
00197157039332 K233509 000
00197157039325 K233509 000
00197157039318 K233509 000
00197157039172 K233509 000
00197157040628 K233509 000
00197157040109 K233509 000
00197157041274 K233509 000
00197157041182 K233509 000
00197157041175 K233509 000
00197157041168 K233509 000
00197157041151 K233509 000
00197157041144 K233509 000
00197157041137 K233509 000
00197157041120 K233509 000
00197157041113 K233509 000
00197157041106 K233509 000
00197157039974 K233509 000
00197157039981 K233509 000
00197157039998 K233509 000
00197157040093 K233509 000
00197157040086 K233509 000
00197157040079 K233509 000
00197157040062 K233509 000
00197157040055 K233509 000
00197157040048 K233509 000
00197157040031 K233509 000
00197157040024 K233509 000
00197157040017 K233509 000
00197157040000 K233509 000
00197157041090 K233509 000
00197157041083 K233509 000
00197157041076 K233509 000
00197157040932 K233509 000
00197157040925 K233509 000
00197157040918 K233509 000
00197157040901 K233509 000
00197157040895 K233509 000
00197157040888 K233509 000
00197157040871 K233509 000
00197157040864 K233509 000
00197157040857 K233509 000
00197157040840 K233509 000
00197157040949 K233509 000
00197157040956 K233509 000
00197157040963 K233509 000
00197157041069 K233509 000
00197157041052 K233509 000
00197157041045 K233509 000
00197157041038 K233509 000
00197157041021 K233509 000
00197157041014 K233509 000
00197157041007 K233509 000
00197157040994 K233509 000
00197157040987 K233509 000
00197157040970 K233509 000
00197157040833 K233509 000
00197157040611 K233509 000
00197157040475 K233509 000
00197157040468 K233509 000
00197157040451 K233509 000
00197157040444 K233509 000
00197157040437 K233509 000
00197157040420 K233509 000
00197157040413 K233509 000
00197157040406 K233509 000
00197157040390 K233509 000
00197157040383 K233509 000
00197157040482 K233509 000
00197157040499 K233509 000
00197157040505 K233509 000
00197157040604 K233509 000
00197157040598 K233509 000
00197157040581 K233509 000
00197157040574 K233509 000
00197157040567 K233509 000
00197157040550 K233509 000
00197157040543 K233509 000
00197157040536 K233509 000
00197157040529 K233509 000
00197157040512 K233509 000
00197157040376 K233509 000
00197157040369 K233509 000
00197157040352 K233509 000
00197157040215 K233509 000
00197157040208 K233509 000
00197157040192 K233509 000
00197157040185 K233509 000
00197157040178 K233509 000
00197157040161 K233509 000
00197157040154 K233509 000
00197157040147 K233509 000
00197157040130 K233509 000
00197157040123 K233509 000
00197157040222 K233509 000
00197157040239 K233509 000
00197157040246 K233509 000
00197157040345 K233509 000
00197157040338 K233509 000
00197157040321 K233509 000
00197157040314 K233509 000
00197157040307 K233509 000
00197157040291 K233509 000
00197157040284 K233509 000
00197157040277 K233509 000
00197157040260 K233509 000
00197157040253 K233509 000
00197157040116 K233509 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.