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 K250908

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
10889981337674 K250908 000
10889981373870 K250908 000
10889981373887 K250908 000
10889981373894 K250908 000
10889981373900 K250908 000
10889981373917 K250908 000
10889981373924 K250908 000
10889981373931 K250908 000
10889981373948 K250908 000
10889981373955 K250908 000
10889981373962 K250908 000
10889981373979 K250908 000
10889981373986 K250908 000
10889981373993 K250908 000
10889981373863 K250908 000
10889981373856 K250908 000
10889981337681 K250908 000
10889981337698 K250908 000
10889981337766 K250908 000
10889981337780 K250908 000
10889981373757 K250908 000
10889981373764 K250908 000
10889981373771 K250908 000
10889981373788 K250908 000
10889981373795 K250908 000
10889981373818 K250908 000
10889981373825 K250908 000
10889981373832 K250908 000
10889981373849 K250908 000
10889981374006 K250908 000
10889981374013 K250908 000
10889981374174 K250908 000
10889981374181 K250908 000
10889981374198 K250908 000
10889981374204 K250908 000
10889981374211 K250908 000
10889981374228 K250908 000
10889981374242 K250908 000
10889981374259 K250908 000
10889981374266 K250908 000
10889981374273 K250908 000
10889981374297 K250908 000
10889981374303 K250908 000
10889981374310 K250908 000
10889981374167 K250908 000
10889981374150 K250908 000
10889981374020 K250908 000
10889981374037 K250908 000
10889981374044 K250908 000
10889981374051 K250908 000
10889981374068 K250908 000
10889981374075 K250908 000
10889981374082 K250908 000
10889981374099 K250908 000
10889981374105 K250908 000
10889981374112 K250908 000
10889981374129 K250908 000
10889981374136 K250908 000
10889981374143 K250908 000
10889981374327 K250908 000
10889981337667 K250908 000
10889981332952 K250908 000
10889981336707 K250908 000
10889981336783 K250908 000
10889981336820 K250908 000
10889981336851 K250908 000
10889981336868 K250908 000
10889981336875 K250908 000
10889981336882 K250908 000
10889981336912 K250908 000
10889981336974 K250908 000
10889981336981 K250908 000
10889981336998 K250908 000
10889981337001 K250908 000
10889981337018 K250908 000
10889981336684 K250908 000
10889981336677 K250908 000
10889981332969 K250908 000
10889981336356 K250908 000
10889981336363 K250908 000
10889981336370 K250908 000
10889981336431 K250908 000
10889981336479 K250908 000
10889981336486 K250908 000
10889981336493 K250908 000
10889981336509 K250908 000
10889981336615 K250908 000
10889981336622 K250908 000
10889981336653 K250908 000
10889981336660 K250908 000
10889981337025 K250908 000
10889981337063 K250908 000
10889981337452 K250908 000
10889981337469 K250908 000
10889981337476 K250908 000
10889981337483 K250908 000
10889981337490 K250908 000
10889981337506 K250908 000
10889981337513 K250908 000
10889981337575 K250908 000
10889981337582 K250908 000
10889981337605 K250908 000
10889981337629 K250908 000
10889981337636 K250908 000
10889981337643 K250908 000
10889981337445 K250908 000
10889981337421 K250908 000
10889981337070 K250908 000
10889981337087 K250908 000
10889981337094 K250908 000
10889981337100 K250908 000
10889981337223 K250908 000
10889981337230 K250908 000
10889981337247 K250908 000
10889981337254 K250908 000
10889981337285 K250908 000
10889981337292 K250908 000
10889981337315 K250908 000
10889981337391 K250908 000
10889981337407 K250908 000
10889981337650 K250908 000
10889981374334 K250908 000
10889981374969 K250908 000
10889981375133 K250908 000
10889981375140 K250908 000
10889981375157 K250908 000
10889981375164 K250908 000
10889981387396 K250908 000
10889981387402 K250908 000
10889981387419 K250908 000
10889981387426 K250908 000
10889981387433 K250908 000
10889981387440 K250908 000
10889981387457 K250908 000
10889981387464 K250908 000
10889981387471 K250908 000
10889981375126 K250908 000
10889981375119 K250908 000
10889981374976 K250908 000
10889981374983 K250908 000
10889981374990 K250908 000
10889981375003 K250908 000
10889981375010 K250908 000
10889981375027 K250908 000
10889981375034 K250908 000
10889981375058 K250908 000
10889981375065 K250908 000
10889981375072 K250908 000
10889981375089 K250908 000
10889981375096 K250908 000
10889981375102 K250908 000
10889981387488 K250908 000
10889981387495 K250908 000
10889981387686 K250908 000
10889981387693 K250908 000
10889981387709 K250908 000
10889981387716 K250908 000
10889981387723 K250908 000
10889981387730 K250908 000
10889981387747 K250908 000
10889981387754 K250908 000
10889981387761 K250908 000
10889981387778 K250908 000
10889981387785 K250908 000
10889981387792 K250908 000
10889981387808 K250908 000
10889981387679 K250908 000
10889981387631 K250908 000
10889981387501 K250908 000
10889981387518 K250908 000
10889981387525 K250908 000
10889981387532 K250908 000
10889981387549 K250908 000
10889981387556 K250908 000
10889981387563 K250908 000
10889981387570 K250908 000
10889981387587 K250908 000
10889981387594 K250908 000
10889981387600 K250908 000
10889981387617 K250908 000
10889981387624 K250908 000
10889981387822 K250908 000
10889981374952 K250908 000
10889981374341 K250908 000
10889981374518 K250908 000
10889981374525 K250908 000
10889981374532 K250908 000
10889981374549 K250908 000
10889981374556 K250908 000
10889981374563 K250908 000
10889981374570 K250908 000
10889981374587 K250908 000
10889981374594 K250908 000
10889981374600 K250908 000
10889981374617 K250908 000
10889981374624 K250908 000
10889981374631 K250908 000
10889981374501 K250908 000
10889981374495 K250908 000
10889981374358 K250908 000
10889981374365 K250908 000
10889981374372 K250908 000
10889981374389 K250908 000
10889981374396 K250908 000
10889981374402 K250908 000
10889981374426 K250908 000
10889981374433 K250908 000
10889981374440 K250908 000
10889981374457 K250908 000
10889981374464 K250908 000
10889981374471 K250908 000
10889981374488 K250908 000
10889981374648 K250908 000
10889981374655 K250908 000
10889981374815 K250908 000
10889981374822 K250908 000
10889981374839 K250908 000
10889981374846 K250908 000
10889981374853 K250908 000
10889981374860 K250908 000
10889981374877 K250908 000
10889981374884 K250908 000
10889981374891 K250908 000
10889981374907 K250908 000
10889981374914 K250908 000
10889981374921 K250908 000
10889981374938 K250908 000
10889981374808 K250908 000
10889981374792 K250908 000
10889981374662 K250908 000
10889981374679 K250908 000
10889981374686 K250908 000
10889981374693 K250908 000
10889981374709 K250908 000
10889981374716 K250908 000
10889981374723 K250908 000
10889981374730 K250908 000
10889981374747 K250908 000
10889981374754 K250908 000
10889981374761 K250908 000
10889981374778 K250908 000
10889981374785 K250908 000
10889981374945 K250908 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.