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 K210980

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
03596010571335 K210980 000
03596010392770 K210980 000
03596010392794 K210980 000
03596010392817 K210980 000
03596010392831 K210980 000
03596010392862 K210980 000
03596010392886 K210980 000
03596010392954 K210980 000
03596010392961 K210980 000
03596010392978 K210980 000
03596010392992 K210980 000
03596010393005 K210980 000
03596010393029 K210980 000
03596010392756 K210980 000
03596010392695 K210980 000
03596010571342 K210980 000
03596010571359 K210980 000
03596010571366 K210980 000
03596010571373 K210980 000
03596010571380 K210980 000
03596010571397 K210980 000
03596010392589 K210980 000
03596010392596 K210980 000
03596010392619 K210980 000
03596010392626 K210980 000
03596010392633 K210980 000
03596010392657 K210980 000
03596010393173 K210980 000
03596010393197 K210980 000
03596010393203 K210980 000
03596010393401 K210980 000
03596010393418 K210980 000
03596010393425 K210980 000
03596010393432 K210980 000
03596010393449 K210980 000
03596010393630 K210980 000
03596010396525 K210980 000
03596010401243 K210980 000
03596010404879 K210980 000
03596010414632 K210980 000
03596010414649 K210980 000
03596010414656 K210980 000
03596010393395 K210980 000
03596010393388 K210980 000
03596010393210 K210980 000
03596010393227 K210980 000
03596010393234 K210980 000
03596010393272 K210980 000
03596010393289 K210980 000
03596010393319 K210980 000
03596010393326 K210980 000
03596010393333 K210980 000
03596010393340 K210980 000
03596010393357 K210980 000
03596010393364 K210980 000
03596010393371 K210980 000
03596010414663 K210980 000
00885556915196 K210980 000
00885556298046 K210980 000
00885556298091 K210980 000
00885556298145 K210980 000
00885556298190 K210980 000
00885556298244 K210980 000
00885556298299 K210980 000
00885556298343 K210980 000
00885556298398 K210980 000
00885556298442 K210980 000
00885556298497 K210980 000
00885556298541 K210980 000
00885556298596 K210980 000
00885556297995 K210980 000
00885556297940 K210980 000
03596010406002 K210980 000
03596010410184 K210980 000
03596010410191 K210980 000
03596010410276 K210980 000
03596010410283 K210980 000
03596010410832 K210980 000
00885556152362 K210980 000
00885556297698 K210980 000
00885556297742 K210980 000
00885556297797 K210980 000
00885556297841 K210980 000
00885556297896 K210980 000
00885556298640 K210980 000
00885556298695 K210980 000
00885556298749 K210980 000
00885556462195 K210980 000
00885556462249 K210980 000
00885556462294 K210980 000
00885556462348 K210980 000
00885556462393 K210980 000
00885556462447 K210980 000
00885556462492 K210980 000
00885556462546 K210980 000
00885556462591 K210980 000
00885556462690 K210980 000
03596010571304 K210980 000
03596010571311 K210980 000
00885556299449 K210980 000
00885556299395 K210980 000
00885556298794 K210980 000
00885556298848 K210980 000
00885556298893 K210980 000
00885556298947 K210980 000
00885556298992 K210980 000
00885556299043 K210980 000
00885556299098 K210980 000
00885556299142 K210980 000
00885556299197 K210980 000
00885556299241 K210980 000
00885556299296 K210980 000
00885556299340 K210980 000
03596010571328 K210980 000
03596010571243 K210980 000
03596010410139 K210980 000
03596010410146 K210980 000
03596010410153 K210980 000
03596010410160 K210980 000
03596010410177 K210980 000
03596010410207 K210980 000
03596010410214 K210980 000
03596010410221 K210980 000
03596010410238 K210980 000
03596010410245 K210980 000
03596010410252 K210980 000
03596010410269 K210980 000
03596010410122 K210980 000
03596010410115 K210980 000
03596010571250 K210980 000
03596010571267 K210980 000
03596010571274 K210980 000
03596010571281 K210980 000
03596010571298 K210980 000
03596010392602 K210980 000
03596010393296 K210980 000
03596010393302 K210980 000
03596010405210 K210980 000
03596010405944 K210980 000
03596010406026 K210980 000
03596010406101 K210980 000
03596010410290 K210980 000
03596010410306 K210980 000
03596010410313 K210980 000
03596010414588 K210980 000
03596010414595 K210980 000
03596010414601 K210980 000
03596010414618 K210980 000
03596010414625 K210980 000
03596010425010 K210980 000
03596010425645 K210980 000
03596010495709 K210980 000
03596010495716 K210980 000
03596010495723 K210980 000
03596010495730 K210980 000
03596010495747 K210980 000
03596010414571 K210980 000
03596010414564 K210980 000
03596010410320 K210980 000
03596010410337 K210980 000
03596010410344 K210980 000
03596010410788 K210980 000
03596010410795 K210980 000
03596010410849 K210980 000
03596010410856 K210980 000
03596010410894 K210980 000
03596010410900 K210980 000
03596010410917 K210980 000
03596010410931 K210980 000
03596010410948 K210980 000
00885556893296 K210980 000
03596010414670 K210980 000
03596010443915 K210980 000
03596010443922 K210980 000
03596010443939 K210980 000
03596010443946 K210980 000
03596010464996 K210980 000
03596010465023 K210980 000
03596010465030 K210980 000
03596010465047 K210980 000
03596010465054 K210980 000
03596010465061 K210980 000
03596010465078 K210980 000
03596010465085 K210980 000
03596010427595 K210980 000
03596010427182 K210980 000
03596010414687 K210980 000
03596010414694 K210980 000
03596010414700 K210980 000
03596010414717 K210980 000
03596010414724 K210980 000
03596010414731 K210980 000
03596010414748 K210980 000
03596010414755 K210980 000
03596010414762 K210980 000
03596010425959 K210980 000
03596010427168 K210980 000
03596010427175 K210980 000
03596010465092 K210980 000
03596010465108 K210980 000
03596010476258 K210980 000
03596010516671 K210980 000
03596010516688 K210980 000
03596010516695 K210980 000
03596010516701 K210980 000
03596010516718 K210980 000
03596010516725 K210980 000
03596010516732 K210980 000
03596010516749 K210980 000
03596010516756 K210980 000
03596010571205 K210980 000
03596010571212 K210980 000
03596010571229 K210980 000
03596010516664 K210980 000
03596010516657 K210980 000
03596010476289 K210980 000
03596010476296 K210980 000
03596010496867 K210980 000
03596010496881 K210980 000
03596010496898 K210980 000
03596010496904 K210980 000
03596010496911 K210980 000
03596010496928 K210980 000
03596010496935 K210980 000
03596010496942 K210980 000
03596010496959 K210980 000
03596010516640 K210980 000
03596010571236 K210980 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.