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 P990075

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
00081317001713 P990075 000
00081317001867 P990075 000
00081317001874 P990075 000
00081317001881 P990075 000
00081317001904 P990075 000
00081317001911 P990075 000
00081317001928 P990075 000
00081317001935 P990075 000
00081317001942 P990075 000
00081317001744 P990075 000
00081317001850 P990075 000
00081317001843 P990075 000
00081317001836 P990075 000
00081317001720 P990075 000
00081317001737 P990075 000
00081317001751 P990075 000
00081317001768 P990075 000
00081317001775 P990075 000
00081317001782 P990075 000
00081317001799 P990075 000
00081317001805 P990075 000
00081317001812 P990075 000
00081317001171 P990075 000
00081317001249 P990075 000
00081317001270 P990075 000
00081317001263 P990075 000
00081317001256 P990075 000
00081317004561 P990075 000
00081317001232 P990075 000
00081317001225 P990075 000
00081317001218 P990075 000
00081317001201 P990075 000
00081317001195 P990075 000
00081317001294 P990075 000
00081317001300 P990075 000
00081317009030 P990075 000
00081317009054 P990075 000
00081317001898 P990075 000
00081317001829 P990075 000
00081317009047 P990075 000
00081317001331 P990075 000
00081317001324 P990075 000
00081317001317 P990075 000
00081317001188 P990075 000
00081317001621 P990075 003
00081317001645 P990075 003
00081317001652 P990075 003
00081317001638 P990075 003
00081317001584 P990075 003
00081317001560 P990075 003
00081317001591 P990075 003
00081317001614 P990075 003
00081317001607 P990075 003
00081317001577 P990075 003
00081317001669 P990075 003
00081317001676 P990075 003
00081317001683 P990075 003
00081317001690 P990075 003
00081317001706 P990075 003
00081317001492 P990075 016
00081317001386 P990075 016
00081317001478 P990075 016
00081317001461 P990075 016
00081317001454 P990075 016
00081317001447 P990075 016
00081317001430 P990075 016
00081317001393 P990075 016
00081317001416 P990075 016
00081317001508 P990075 016
00081317001515 P990075 016
00081317001522 P990075 016
00081317001348 P990075 016
00081317001423 P990075 016
00081317001355 P990075 016
00081317001379 P990075 016
00081317001485 P990075 016
00081317001362 P990075 016
00081317001539 P990075 016
00081317001409 P990075 016
10081317029028 P990075 019
10081317029035 P990075 019
10081317029011 P990075 019
10081317029004 P990075 019
10081317028991 P990075 019
10081317028984 P990075 019
10081317028977 P990075 019
10081317028960 P990075 019
10081317028953 P990075 019
10081317029042 P990075 019
10081317029059 P990075 019
10081317029141 P990075 019
10081317029127 P990075 019
10081317029110 P990075 019
10081317029103 P990075 019
10081317029097 P990075 019
10081317029080 P990075 019
10081317029134 P990075 019
10081317029073 P990075 019
10081317029066 P990075 019
10081317029158 P990075 019
10081317028946 P990075 019
10081317028762 P990075 019
10081317028755 P990075 019
10081317028724 P990075 019
10081317028748 P990075 019
10081317028731 P990075 019
10081317028717 P990075 019
10081317028700 P990075 019
10081317028694 P990075 019
10081317028687 P990075 019
10081317028779 P990075 019
10081317028786 P990075 019
10081317028939 P990075 019
10081317028861 P990075 019
10081317028854 P990075 019
10081317028847 P990075 019
10081317028830 P990075 019
10081317028823 P990075 019
10081317028816 P990075 019
10081317028809 P990075 019
10081317028793 P990075 019
10081317028670 P990075 019
10081317030468 P990075 019
00081317002024 P990075 019
00081317002079 P990075 019
00081317002086 P990075 019
00081317002093 P990075 019
00081317002109 P990075 019
00081317002116 P990075 019
00081317002123 P990075 019
00081317002130 P990075 019
00081317002147 P990075 019
00081317002062 P990075 019
00081317002055 P990075 019
00081317002048 P990075 019
00081317001959 P990075 019
00081317001966 P990075 019
00081317001973 P990075 019
00081317001980 P990075 019
00081317001997 P990075 019
00081317002000 P990075 019
00081317002017 P990075 019
00081317002031 P990075 019
00081317002154 P990075 019
00081317002161 P990075 019
10081317030567 P990075 019
10081317030550 P990075 019
10081317030543 P990075 019
10081317030536 P990075 019
10081317030529 P990075 019
10081317030512 P990075 019
10081317030505 P990075 019
10081317030499 P990075 019
10081317030482 P990075 019
10081317030574 P990075 019
10081317030581 P990075 019
00081317002178 P990075 019
00081317004059 P990075 019
10081317030642 P990075 019
10081317030635 P990075 019
10081317030628 P990075 019
10081317030611 P990075 019
10081317030604 P990075 019
10081317030598 P990075 019
10081317030475 P990075 019
00081317001287 P990075 022

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.