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 K232200

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
16942067959772 K232200 000
16942067959574 K232200 000
16942067959567 K232200 000
16942067959550 K232200 000
16942067959543 K232200 000
16942067959536 K232200 000
16942067959529 K232200 000
16942067959512 K232200 000
16942067959505 K232200 000
16942067959499 K232200 000
16942067959482 K232200 000
16942067959475 K232200 000
16942067959468 K232200 000
16942067959451 K232200 000
16942067959444 K232200 000
16942067959437 K232200 000
16942067959420 K232200 000
16942067959581 K232200 000
16942067959598 K232200 000
16942067959604 K232200 000
16942067959765 K232200 000
16942067959758 K232200 000
16942067959741 K232200 000
16942067959734 K232200 000
16942067959727 K232200 000
16942067959710 K232200 000
16942067959703 K232200 000
16942067959697 K232200 000
16942067959680 K232200 000
16942067959673 K232200 000
16942067959666 K232200 000
16942067959659 K232200 000
16942067959642 K232200 000
16942067959635 K232200 000
16942067959628 K232200 000
16942067959611 K232200 000
16942067959413 K232200 000
16942067959406 K232200 000
16942067959390 K232200 000
16942067959192 K232200 000
16942067959185 K232200 000
16942067959178 K232200 000
16942067959161 K232200 000
16942067959154 K232200 000
16942067959147 K232200 000
16942067959130 K232200 000
16942067959123 K232200 000
16942067959116 K232200 000
16942067959109 K232200 000
16942067959093 K232200 000
16942067959086 K232200 000
16942067959079 K232200 000
16942067959062 K232200 000
16942067959055 K232200 000
16942067959024 K232200 000
16942067959208 K232200 000
16942067959215 K232200 000
16942067959222 K232200 000
16942067959383 K232200 000
16942067959376 K232200 000
16942067959369 K232200 000
16942067959352 K232200 000
16942067959345 K232200 000
16942067959338 K232200 000
16942067959321 K232200 000
16942067959314 K232200 000
16942067959307 K232200 000
16942067959291 K232200 000
16942067959284 K232200 000
16942067959277 K232200 000
16942067959260 K232200 000
16942067959253 K232200 000
16942067959246 K232200 000
16942067959239 K232200 000
06942067959010 K232200 000
16942067959048 K232200 000
16942067960327 K232200 000
16942067960310 K232200 000
16942067960303 K232200 000
16942067960297 K232200 000
16942067960280 K232200 000
16942067960273 K232200 000
16942067960266 K232200 000
16942067960259 K232200 000
16942067960242 K232200 000
16942067960235 K232200 000
16942067960228 K232200 000
16942067960211 K232200 000
16942067960204 K232200 000
16942067960198 K232200 000
16942067960181 K232200 000
16942067960174 K232200 000
16942067960334 K232200 000
16942067960341 K232200 000
16942067960358 K232200 000
16942067959031 K232200 000
16942067960501 K232200 000
16942067960495 K232200 000
16942067960488 K232200 000
16942067960471 K232200 000
16942067960464 K232200 000
16942067960457 K232200 000
16942067960440 K232200 000
16942067960433 K232200 000
16942067960426 K232200 000
16942067960419 K232200 000
16942067960402 K232200 000
16942067960396 K232200 000
16942067960389 K232200 000
16942067960372 K232200 000
16942067960365 K232200 000
16942067960167 K232200 000
16942067960150 K232200 000
16942067960143 K232200 000
16942067959949 K232200 000
16942067959932 K232200 000
16942067959925 K232200 000
16942067959918 K232200 000
16942067959901 K232200 000
16942067959895 K232200 000
16942067959888 K232200 000
16942067959871 K232200 000
16942067959864 K232200 000
16942067959857 K232200 000
16942067959840 K232200 000
16942067959833 K232200 000
16942067959826 K232200 000
16942067959819 K232200 000
16942067959802 K232200 000
16942067959796 K232200 000
16942067959956 K232200 000
16942067959963 K232200 000
16942067959970 K232200 000
16942067960136 K232200 000
16942067960129 K232200 000
16942067960112 K232200 000
16942067960105 K232200 000
16942067960099 K232200 000
16942067960082 K232200 000
16942067960075 K232200 000
16942067960068 K232200 000
16942067960051 K232200 000
16942067960044 K232200 000
16942067960037 K232200 000
16942067960020 K232200 000
16942067960013 K232200 000
16942067960006 K232200 000
16942067959994 K232200 000
16942067959987 K232200 000
16942067959789 K232200 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


© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.