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 K220079

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
08800177381740 K220079 000
08800039370332 K220079 000
08800039370325 K220079 000
08800039370301 K220079 000
08800039370288 K220079 000
08800039368933 K220079 000
08800039365178 K220079 000
08800039363754 K220079 000
08800039363747 K220079 000
08800039363730 K220079 000
08800039363723 K220079 000
08800039363716 K220079 000
08800039363709 K220079 000
08800039363693 K220079 000
08800039363686 K220079 000
08800039363679 K220079 000
08800039363662 K220079 000
08800039363655 K220079 000
08800039370349 K220079 000
08800039370356 K220079 000
08800090661271 K220079 000
08800090661264 K220079 000
08800090661257 K220079 000
08800090661240 K220079 000
08800090661134 K220079 000
08800090661127 K220079 000
08800090661110 K220079 000
08800090661103 K220079 000
08800090661097 K220079 000
08800039393584 K220079 000
08800039393577 K220079 000
08800039370615 K220079 000
08800039370608 K220079 000
08800039370592 K220079 000
08800039370585 K220079 000
08800039370578 K220079 000
08800039370363 K220079 000
08800039363648 K220079 000
08800039363631 K220079 000
08800039363433 K220079 000
08800039363426 K220079 000
08800039363419 K220079 000
08800039363402 K220079 000
08800039363396 K220079 000
08800039363389 K220079 000
08800039363372 K220079 000
08800039363365 K220079 000
08800039363358 K220079 000
08800039363341 K220079 000
08800039363334 K220079 000
08800039363327 K220079 000
08800039363310 K220079 000
08800039363303 K220079 000
08800039363297 K220079 000
08800039363280 K220079 000
08800039363273 K220079 000
08800039363440 K220079 000
08800039363457 K220079 000
08800039363624 K220079 000
08800039363617 K220079 000
08800039363600 K220079 000
08800039363594 K220079 000
08800039363587 K220079 000
08800039363570 K220079 000
08800039363563 K220079 000
08800039363556 K220079 000
08800039363549 K220079 000
08800039363532 K220079 000
08800039363525 K220079 000
08800039363518 K220079 000
08800039363501 K220079 000
08800039363495 K220079 000
08800039363488 K220079 000
08800039363471 K220079 000
08800039363464 K220079 000
08800039363266 K220079 000
08800177381757 K220079 000
08809986615275 K220079 000
08809986615077 K220079 000
08809986615060 K220079 000
08809986615053 K220079 000
08809986615046 K220079 000
08809986619686 K220079 000
08809986619679 K220079 000
08809986619662 K220079 000
08809986609465 K220079 000
08800177382235 K220079 000
08800177382228 K220079 000
08800177382211 K220079 000
08800177382204 K220079 000
08800177382198 K220079 000
08800177382181 K220079 000
08800177382174 K220079 000
08800177382167 K220079 000
08800177382150 K220079 000
08809986615084 K220079 000
08809986615091 K220079 000
08809986615268 K220079 000
08809986615251 K220079 000
08809986615244 K220079 000
08809986615237 K220079 000
08809986615220 K220079 000
08809986615213 K220079 000
08809986615206 K220079 000
08809986615190 K220079 000
08809986615183 K220079 000
08809986615176 K220079 000
08809986615169 K220079 000
08809986615152 K220079 000
08809986615145 K220079 000
08809986615138 K220079 000
08809986615121 K220079 000
08809986615114 K220079 000
08809986615107 K220079 000
08800177382143 K220079 000
08800177382136 K220079 000
08800177381931 K220079 000
08800177381924 K220079 000
08800177381917 K220079 000
08800177381900 K220079 000
08800177381894 K220079 000
08800177381887 K220079 000
08800177381870 K220079 000
08800177381863 K220079 000
08800177381856 K220079 000
08800177381849 K220079 000
08800177381832 K220079 000
08800177381825 K220079 000
08800177381818 K220079 000
08800177381801 K220079 000
08800177381795 K220079 000
08800177381788 K220079 000
08800177381771 K220079 000
08800177381948 K220079 000
08800177381955 K220079 000
08800177382129 K220079 000
08800177382112 K220079 000
08800177382105 K220079 000
08800177382099 K220079 000
08800177382082 K220079 000
08800177382075 K220079 000
08800177382068 K220079 000
08800177382051 K220079 000
08800177382044 K220079 000
08800177382037 K220079 000
08800177382020 K220079 000
08800177382013 K220079 000
08800177382006 K220079 000
08800177381993 K220079 000
08800177381986 K220079 000
08800177381979 K220079 000
08800177381962 K220079 000
08800177381764 K220079 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.