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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
G2308H2AF08S070	K222004	000
G2308H2AF11L100	K222004	000
G2308H2AF11M070	K222004	000
G2308H2AF11M100	K222004	000
G2308H2AF11S070	K222004	000
G2308H2AF11S100	K222004	000
G2308H2AF12L070	K222004	000
G2308H2AF12L100	K222004	000
G2308H2AF12M070	K222004	000
G2308H2AF12M100	K222004	000
G2308H2AF12S070	K222004	000
G2308H2AF12S100	K222004	000
G2308H2AF11L070	K222004	000
G2308H2AF10S100	K222004	000
G2308H2AF10S070	K222004	000
G2308H2AF08S100	K222004	000
G2308H2AF09L070	K222004	000
G2308H2AF09L100	K222004	000
G2308H2AF09M070	K222004	000
G2308H2AF09M100	K222004	000
G2308H2AF09S070	K222004	000
G2308H2AF09S100	K222004	000
G2308H2AF10L070	K222004	000
G2308H2AF10L100	K222004	000
G2308H2AF10M070	K222004	000
G2308H2AF10M100	K222004	000
G2308H2AF13L070	K222004	000
G2308H2AF13L100	K222004	000
G2308H1CR012S100	K222004	000
G2308H1CR012S70	K222004	000
G2308H1CR034L100	K222004	000
G2308H1CR034L70	K222004	000
G2308H1CR034M100	K222004	000
G2308H1CR034M70	K222004	000
G2308H1CR034S100	K222004	000
G2308H1CR034S70	K222004	000
G2308H1CR056L100	K222004	000
G2308H1CR056L70	K222004	000
G2308H1CR056M100	K222004	000
G2308H1CR012M70	K222004	000
G2308H1CR012M100	K222004	000
G2308H1CR012L70	K222004	000
G2308H2AF13M070	K222004	000
G2308H2AF13M100	K222004	000
G2308H2AF13S070	K222004	000
G2308H2AF13S100	K222004	000
G2308H2AF14L070	K222004	000
G2308H2AF14L100	K222004	000
G2308H2AF14M070	K222004	000
G2308H2AF14M100	K222004	000
G2308H2AF14S070	K222004	000
G2308H2AF14S100	K222004	000
G2308H1CR012L100	K222004	000
G2308H1CR056M70	K222004	000
G2308H1FT13S100	K222004	000
G2308H1CR90M100	K222004	000
G2308H1CR90S100	K222004	000
G2308HT0506L100	K222004	000
G2308HT0506M100	K222004	000
G2308HT0506S100	K222004	000
G2308HT0708L100	K222004	000
G2308HT0708M100	K222004	000
G2308HT0708S100	K222004	000
G2308HT0910L100	K222004	000
G2308HT0910M100	K222004	000
G2308HT0910S100	K222004	000
G2308H1CR90L100	K222004	000
G2308H1CR78S100	K222004	000
G2308H1CR78M100	K222004	000
G2308H1FT14S100	K222004	000
G2308H1CR12L100	K222004	000
G2308H1CR12M100	K222004	000
G2308H1CR12S100	K222004	000
G2308H1CR34L100	K222004	000
G2308H1CR34M100	K222004	000
G2308H1CR34S100	K222004	000
G2308H1CR56L100	K222004	000
G2308H1CR56M100	K222004	000
G2308H1CR56S100	K222004	000
G2308H1CR78L100	K222004	000
G2308HT1112L100	K222004	000
G2308HT1112M100	K222004	000
G2308H2AF06S070	K222004	000
G2308H2AF06S100	K222004	000
G2308H2AF07L070	K222004	000
G2308H2AF07L100	K222004	000
G2308H2AF07M070	K222004	000
G2308H2AF07M100	K222004	000
G2308H2AF07S070	K222004	000
G2308H2AF07S100	K222004	000
G2308H2AF08L070	K222004	000
G2308H2AF08L100	K222004	000
G2308H2AF08M070	K222004	000
G2308H2AF06M100	K222004	000
G2308H2AF06M070	K222004	000
G2308H2AF06L100	K222004	000
G2308HT1112S100	K222004	000
G2308HT1314L100	K222004	000
G2308HT1314M100	K222004	000
G2308HT1314S100	K222004	000
G2308H2AF05L070	K222004	000
G2308H2AF05L100	K222004	000
G2308H2AF05M070	K222004	000
G2308H2AF05M100	K222004	000
G2308H2AF05S070	K222004	000
G2308H2AF05S100	K222004	000
G2308H2AF06L070	K222004	000
G2308H2AF08M100	K222004	000
G2308H1CR056S100	K222004	000
G2308H2AC08L070	K222004	000
G2308H2AC05M100	K222004	000
G2308H2AC06M070	K222004	000
G2308H2AC06M100	K222004	000
G2308H2AC06S100	K222004	000
G2308H2AC07M070	K222004	000
G2308H2AC07M100	K222004	000
G2308H2AC07S100	K222004	000
G2308H2AC08M070	K222004	000
G2308H2AC08M100	K222004	000
G2308H2AC08S100	K222004	000
G2308H2AC09M070	K222004	000
G2308H2AC05M070	K222004	000
G2308H2AC14L100	K222004	000
G2308H2AC14L070	K222004	000
G2308H2AC08L100	K222004	000
G2308H2AC09L070	K222004	000
G2308H2AC09L100	K222004	000
G2308H2AC10L070	K222004	000
G2308H2AC10L100	K222004	000
G2308H2AC11L070	K222004	000
G2308H2AC11L100	K222004	000
G2308H2AC12L070	K222004	000
G2308H2AC12L100	K222004	000
G2308H2AC13L070	K222004	000
G2308H2AC13L100	K222004	000
G2308H2AC09M100	K222004	000
G2308H2AC09S100	K222004	000
G2308H2AC14S100	K222004	000
G2308H2AC05S100	K222004	000
G2308H2AC06S070	K222004	000
G2308H2AC07S070	K222004	000
G2308H2AC08S070	K222004	000
G2308H2AC09S070	K222004	000
G2308H2AC10S070	K222004	000
G2308H2AC11S070	K222004	000
G2308H2AC12S070	K222004	000
G2308H2AC13S070	K222004	000
G2308H2AC14S070	K222004	000
G2308H2AC14M100	K222004	000
G2308H2AC14M070	K222004	000
G2308H2AC13S100	K222004	000
G2308H2AC10M070	K222004	000
G2308H2AC10M100	K222004	000
G2308H2AC10S100	K222004	000
G2308H2AC11M070	K222004	000
G2308H2AC11M100	K222004	000
G2308H2AC11S100	K222004	000
G2308H2AC12M070	K222004	000
G2308H2AC12M100	K222004	000
G2308H2AC12S100	K222004	000
G2308H2AC13M070	K222004	000
G2308H2AC13M100	K222004	000
G2308H2AC05S070	K222004	000
G2308H1CR056S70	K222004	000
G2308H1CM000450	K222004	000
G2308H1CR000210	K222004	000
G2308H1CT012L100	K222004	000
G2308H1CT012L70	K222004	000
G2308H1CT012M100	K222004	000
G2308H1CT012M70	K222004	000
G2308H1CT012S100	K222004	000
G2308H1CT012S70	K222004	000
G2308H1CT034L100	K222004	000
G2308H1CT034L70	K222004	000
G2308H1CT034M100	K222004	000
G2308H1CH000310	K222004	000
G2308H1CH000230	K222004	000
G2308H1CR090S70	K222004	000
G2308H1CR078L100	K222004	000
G2308H1CR078L70	K222004	000
G2308H1CR078M100	K222004	000
G2308H1CR078M70	K222004	000
G2308H1CR078S100	K222004	000
G2308H1CR078S70	K222004	000
G2308H1CR090L100	K222004	000
G2308H1CR090L70	K222004	000
G2308H1CR090M100	K222004	000
G2308H1CR090M70	K222004	000
G2308H1CR090S100	K222004	000
G2308H1CT034M70	K222004	000
G2308H1CT034S100	K222004	000
G2308H1CT090M100	K222004	000
G2308H1CT090M70	K222004	000
G2308H1CT090S100	K222004	000
G2308H1CT090S70	K222004	000
G2308H1CZ001390	K222004	000
G2308H1CT056S70	K222004	000
G2308H2AC05L070	K222004	000
G2308H2AC05L100	K222004	000
G2308H2AC06L070	K222004	000
G2308H2AC06L100	K222004	000
G2308H2AC07L070	K222004	000
G2308H1CT090L70	K222004	000
G2308H1CT090L100	K222004	000
G2308H1CT078S70	K222004	000
G2308H1CT034S70	K222004	000
G2308H1CT056L100	K222004	000
G2308H1CT056L70	K222004	000
G2308H1CT056M100	K222004	000
G2308H1CT056M70	K222004	000
G2308H1CT056S100	K222004	000
G2308H1CT078L100	K222004	000
G2308H1CT078L70	K222004	000
G2308H1CT078M100	K222004	000
G2308H1CT078M70	K222004	000
G2308H1CT078S100	K222004	000
G2308H2AC07L100	K222004	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