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 K243740

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
07899258664804 K243740 000
07899258664613 K243740 000
07899258664606 K243740 000
07899258664590 K243740 000
07899258664583 K243740 000
07899258664576 K243740 000
07899258664569 K243740 000
07899258664552 K243740 000
07899258664545 K243740 000
07899258664538 K243740 000
07899258664521 K243740 000
07899258664514 K243740 000
07899258664507 K243740 000
07899258664491 K243740 000
07899258664484 K243740 000
07899258664477 K243740 000
07899258664460 K243740 000
07899258664620 K243740 000
07899258664637 K243740 000
07899258664798 K243740 000
07899258664781 K243740 000
07899258664774 K243740 000
07899258664767 K243740 000
07899258664750 K243740 000
07899258664743 K243740 000
07899258664736 K243740 000
07899258664729 K243740 000
07899258664712 K243740 000
07899258664705 K243740 000
07899258664699 K243740 000
07899258664682 K243740 000
07899258664675 K243740 000
07899258664668 K243740 000
07899258664651 K243740 000
07899258664644 K243740 000
07899258665511 K243740 000
07899258665504 K243740 000
07899258665498 K243740 000
07899258665306 K243740 000
07899258665290 K243740 000
07899258665283 K243740 000
07899258665276 K243740 000
07899258665269 K243740 000
07899258665252 K243740 000
07899258665245 K243740 000
07899258665238 K243740 000
07899258665221 K243740 000
07899258665214 K243740 000
07899258665207 K243740 000
07899258665191 K243740 000
07899258665184 K243740 000
07899258665177 K243740 000
07899258665160 K243740 000
07899258665153 K243740 000
07899258665313 K243740 000
07899258665320 K243740 000
07899258665481 K243740 000
07899258665474 K243740 000
07899258665467 K243740 000
07899258665450 K243740 000
07899258665443 K243740 000
07899258665436 K243740 000
07899258665429 K243740 000
07899258665412 K243740 000
07899258665405 K243740 000
07899258665399 K243740 000
07899258665382 K243740 000
07899258665375 K243740 000
07899258665368 K243740 000
07899258665351 K243740 000
07899258665344 K243740 000
07899258665337 K243740 000
07899258665146 K243740 000
07899258664194 K243740 000
07899258664385 K243740 000
07899258664378 K243740 000
07899258664361 K243740 000
07899258664354 K243740 000
07899258664347 K243740 000
07899258664330 K243740 000
07899258664323 K243740 000
07899258664316 K243740 000
07899258664309 K243740 000
07899258664293 K243740 000
07899258664286 K243740 000
07899258664279 K243740 000
07899258664262 K243740 000
07899258664255 K243740 000
07899258664248 K243740 000
07899258664231 K243740 000
07899258664392 K243740 000
07899258664408 K243740 000
07899258664187 K243740 000
07899258664170 K243740 000
07899258664163 K243740 000
07899258664156 K243740 000
07899258664149 K243740 000
07899258664132 K243740 000
07899258664125 K243740 000
07899258664118 K243740 000
07899258664101 K243740 000
07899258664095 K243740 000
07899258664088 K243740 000
07899258664071 K243740 000
07899258664064 K243740 000
07899258664439 K243740 000
07899258664422 K243740 000
07899258664415 K243740 000
07899258664224 K243740 000
07899258664217 K243740 000
07899258664200 K243740 000
07899258664972 K243740 000
07899258664965 K243740 000
07899258664958 K243740 000
07899258664941 K243740 000
07899258664934 K243740 000
07899258664927 K243740 000
07899258664910 K243740 000
07899258664903 K243740 000
07899258664897 K243740 000
07899258664880 K243740 000
07899258664873 K243740 000
07899258664866 K243740 000
07899258664859 K243740 000
07899258664842 K243740 000
07899258664835 K243740 000
07899258664828 K243740 000
07899258664989 K243740 000
07899258664996 K243740 000
07899258664453 K243740 000
07899258664446 K243740 000
07899258665139 K243740 000
07899258665122 K243740 000
07899258665115 K243740 000
07899258665108 K243740 000
07899258665092 K243740 000
07899258665085 K243740 000
07899258665078 K243740 000
07899258665061 K243740 000
07899258665054 K243740 000
07899258665047 K243740 000
07899258665030 K243740 000
07899258665023 K243740 000
07899258665016 K243740 000
07899258665009 K243740 000
07899258664811 K243740 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.