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 P020045

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
00613994610935 P020045 000
00613994610652 P020045 000
00613994611109 P020045 000
00613994610959 P020045 000
00613994610942 P020045 000
00613994610928 P020045 000
00613994610911 P020045 000
00613994610898 P020045 000
00613994610676 P020045 000
00613994610669 P020045 000
20613994775560 P020045 000
00613994610904 P020045 000
00643169957220 P020045 000
00613994610690 P020045 000
00613994610805 P020045 005
00613994610812 P020045 005
00613994610829 P020045 005
00613994686077 P020045 026
00613994775955 P020045 026
00643169023536 P020045 037
00643169023659 P020045 037
00643169023567 P020045 037
00643169023512 P020045 037
00643169023581 P020045 037
00643169023598 P020045 037
00643169023604 P020045 037
00643169023642 P020045 037
00643169023529 P020045 037
00643169023611 P020045 037
00643169023635 P020045 037
00643169023574 P020045 037
00643169023505 P020045 037
00643169023499 P020045 037
00613994981370 P020045 037
20643169023301 P020045 037
00643169023314 P020045 037
00643169023338 P020045 037
20643169023349 P020045 037
00643169023352 P020045 037
00643169023420 P020045 037
00643169023437 P020045 037
00643169023444 P020045 037
00613994981387 P020045 037
00643169519404 P020045 037
00643169023666 P020045 037
00643169023673 P020045 037
20613994775980 P020045 037
00643169023727 P020045 037
00643169023871 P020045 037
00643169023864 P020045 037
00643169023840 P020045 037
00643169023833 P020045 037
00643169023796 P020045 037
00643169023765 P020045 037
00643169023857 P020045 037
00643169023680 P020045 037
00643169023710 P020045 037
00643169023703 P020045 037
00643169023697 P020045 037
00643169195844 P020045 045
00643169203150 P020045 045
00643169273405 P020045 046
00613994775993 P020045 049
00643169279063 P020045 049
00643169449596 P020045 049
00763000306656 P020045 049
00763000306588 P020045 049
00763000306519 P020045 049
00763000306595 P020045 049
00763000306571 P020045 049
00613994775979 P020045 049
00613994776006 P020045 049
00613994775832 P020045 049
00613994775788 P020045 049
00613994775801 P020045 049
00613994775849 P020045 049
00613994775856 P020045 049
00613994775863 P020045 049
00613994775870 P020045 049
00613994775900 P020045 049
00613994775931 P020045 049
00643169450400 P020045 055
00643169450394 P020045 055
00643169450363 P020045 055
00643169450356 P020045 055
00643169450349 P020045 055
00643169450332 P020045 055
00643169450325 P020045 055
00643169450417 P020045 055
00643169504936 P020045 061
00643169504943 P020045 061
00643169504950 P020045 061
00643169504929 P020045 061
00643169504912 P020045 061
00643169504769 P020045 061
00643169504752 P020045 061
00643169504745 P020045 061
00643169352476 P020045 064
00643169352575 P020045 065
00643169352582 P020045 065
00643169352599 P020045 065
00643169352568 P020045 065
00643169352551 P020045 065
00643169352520 P020045 065
00643169352490 P020045 065
00643169352414 P020045 065
00643169352384 P020045 065
00763000306601 P020045 065
20643169352784 P020045 065
20643169352777 P020045 065
00763000306618 P020045 065
00643169352605 P020045 065
00643169352612 P020045 065
00643169352629 P020045 065
00643169352766 P020045 065
00643169352759 P020045 065
00643169352742 P020045 065
00643169352735 P020045 065
00643169352728 P020045 065
00643169352711 P020045 065
00643169352704 P020045 065
00643169352698 P020045 065
00643169495791 P020045 065
00643169352636 P020045 065
00643169352643 P020045 065
00643169352650 P020045 065
00643169352667 P020045 065
00643169352674 P020045 065
00643169352681 P020045 065
00643169495807 P020045 067
00763000306502 P020045 067
00763000306496 P020045 067
00643169352506 P020045 067
00643169496095 P020045 067
00643169672475 P020045 073
00643169672468 P020045 073
00643169672482 P020045 073
00643169946644 P020045 078
20643169950157 P020045 080
00643169950146 P020045 080
20763000279770 P020045 081
00763000279745 P020045 081
20763000279756 P020045 081
00763000279769 P020045 081
00643169983892 P020045 083
00763000011147 P020045 084
20763000228686 P020045 092
00763000228675 P020045 092
20763000412573 P020045 092
00763000412562 P020045 092
00763000359355 P020045 095
00763000359362 P020045 095
00763000645335 P020045 098
00763000645328 P020045 098
00763000645342 P020045 098
00763000486778 P020045 103
00763000593902 P020045 105
00763000593889 P020045 105

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.