Data catalog

FDA FOIA requests

About 15K records

More records

Continuing the FDA FOIA requests list, 1000 records per page.

2022-5984P160008
2025-12609K231473
2018-3545K151068
2020-6941K173906
2017-358K162421
2017-318FEI 3010511300
2019-7878K113780
2020-5906Form FDA 483, FEI 3003708554
2023-10272K231551
2023-3328Form FDA 483, FEI 1000136478
2015-4710K844504, K851816, K851817
2023-9405Form FDA 483, FEI 3009672666
2025-3347K240062
2023-5512K121173
2018-5138K093159
2015-6314K132522
2016-4740K082556
2019-11562EIR
2018-7058K922123
2021-1462K171959
2017-8391K100442
2020-3663K110826
2021-4809K163234, K170848, K170960
2014-9726K093161, K122702
2022-5228EIR, FEI 3004161147
2016-1954K151413
2019-772K173675, K180205, K181206
2023-6822FEI 3009423112
2019-6231K153236
2023-4700K163549, K223609
2016-4585K010346, K011841, K946147
2019-8738K061314
2016-4631K011034
2015-4181K150155
2016-4395K141358, K150831, K151593
2022-6664Form FDA 483, FEI 1413475
2021-4513K963624
2017-3993K854755
2021-4668K191407
2015-2178K121790
2016-8875K021737
2021-3325K120368
2017-6496K152550
2016-1102K091261
2015-4924K853607, K864696, K875066
2017-4742K060618
2019-6505K191000
2022-8804K121289
2017-9802K083460
2017-9020K163614
2018-5972K171584
2025-11743Form FDA 483, FEI 6749
2021-3941K992664
2017-8051K163512
2017-741K071328
2021-6969K180818
2021-936K123910
2018-4015K943508
2026-8757FEI 3020347218
2017-8548P160030
2018-4360K031099
2025-7245K171886
2015-6974K873996
2022-1996EIR, FEI 3004158247
2018-775K172398
2024-4479K140503
2015-3292K031789, K090197
2016-8632K130670
2023-921Form FDA 483, FEI 3006845464
2024-207K201525
2015-553K130349
2023-11563Form FDA 483, FEI 3932
2026-9401Form FDA 483, FEI 1218058
2018-9539K170981
2025-7379K894259
2017-10457K171392
2016-6146K130419
2018-1133K091978
2016-6782K140951
2019-9119K120775
2020-3825K180075
2026-8078Form FDA 483, FEI 3005921952
2023-6725Form FDA 483, FEI 3020115
2023-9008FEI 1417519
2021-8676K212456
2025-13669Form FDA 483, FEI 4395
2026-8077Form FDA 483, FEI 3034676730
2026-8972Form FDA 483, FEI 3027031650
2017-4910K962863
2018-6684K000855
2021-183Form FDA 483
2021-2967K202784
2016-6669K030857
2023-7623FEI 1220246
2017-1975K093932
2023-41K132540
2016-1104K081942
2024-10988K073693, K083453
2023-11013P930038
2022-1632Form FDA 483, FEI 3009164985
2022-7080Form FDA 483, FEI 3003574171
2024-9960K093027
2026-9103K011489, K071830
2018-8520K171408
2025-1537Form FDA 483, FEI 3003058448
2019-2937K112911
2024-2474K173156
2015-9346K103576
2025-11831Form FDA 483, FEI 3012322979
2017-8155K112860
2018-6380K061771
2015-8892P010032
2016-1751K053095, K072956, K080315
2024-5829K202106
2025-1659K181420
2026-1423Form FDA 483, FEI 3018783057
2021-4776K151814
2023-10227Form FDA 483, FEI 2013342
2024-3577Form FDA 483, FEI 4498
2026-4675Form FDA 483, FEI 3004069780
2016-9781P040003
2024-4965K122831
2026-4938Form FDA 483, FEI 3024580094
2022-3296K212470
2024-4524K223882
2018-8701K060463
2022-7044Form FDA 483, FEI 3017865349
2021-3746K040317
2018-7437K043248, K110123, K112990
2017-788K143003
2017-236K091009, K103654, K141101
2020-529P090031
2025-3425K210998
2016-7228K062907
2025-9202K861985
2017-5446K162060
2014-8110K103110
2014-9534K141967
2019-3248K002717
2022-6136K053597
2015-8969K091029
2023-6220K161106
2023-10070Form FDA 483, FEI 1000522098
2021-1957K173300
2022-6580K200717
2018-6833K112119
2025-11561Form FDA 483, FEI 3012441529
2019-9592K001962, K013971, K023075
2021-2224FEI 3006784948
2022-4256K213606
2018-3346K905285, K911189, K913185
2016-9948K963305
2025-2342Form FDA 483, FEI 3003059934
2021-7470K133701
2021-3885K053451
2021-3607P990018
2015-5304K932438
2016-1384K150407
2025-8841Form FDA 483, FEI 1825660
2025-7416Form FDA 483, FEI 3007886372
2025-2170K161165
2023-1424K101170
2026-4833Form FDA 483, FEI 3003766921
2025-12096Form FDA 483, FEI 3005998761
2024-1200Form FDA 483, FEI 3010386387
2023-9537Form FDA 483, FEI 3006430881
2021-6619K203155
2023-7576K141145
2018-648K946106
2023-10802Form FDA 483, FEI 3012159165
2020-6912K113819
2018-31K122904
2018-3556K172186
2017-758K132890
2026-4807Form FDA 483, FEI 3015177815
2021-3068K203782
2019-6274K103305, K112226, K130847
2016-8132K103477
2023-9968EIR, FEI 3007113487
2016-2952K140392
2017-5564Form FDA 483, FEI 3788
2024-5828K093694
2016-3323K101098
2016-2223K121447
2015-3120K130978
2017-4646K162670
2019-1819K022447
2024-9366K211309, K231553
2015-2315K053655
2024-9641K200278
2026-9369Form FDA 483, FEI 3008642652
2017-2996K112168
2018-3455K010139, K101997, K140178
2022-4985Form FDA 483, FEI 1628114
2016-3613K964853
2026-9116Form FDA 483, FEI 1220908
2020-1047K170867
2020-2968K081385
2024-10312Form FDA 483, FEI 3021784063
2023-5108Form FDA 483, FEI 3002783962
2023-10068Form FDA 483, FEI 3005609751
2024-2411Form FDA 483, FEI 3002808337
2022-5581FEI 3014273254
2017-161K030742, K071042, K152665
2025-10451Form FDA 483, FEI 2648729
2016-7565K123662
2020-4994P140003
2017-9258K060341, K935380
2023-5997Form FDA 483, FEI 1000221028
2023-2775K972382
2017-4717K991864
2018-3367K173669
2026-5085K253391
2018-8567K112342
2018-5781K180394
2020-7949Form FDA 483, FEI 1000519796
2026-5759K093310
2024-7313Form FDA 483, FEI 3007208829
2026-6584K013513, K090278
2014-8855K111501
2025-8928P100018, P100018S034
2021-370K173761, K190010, K191946
2017-3636K151794
2018-5304K162475
2019-932K180820
2018-3554K173958
2019-10666K052989, K142932, K172457
2019-799K130613, K130614
2025-12094Form FDA 483, FEI 3021219789
2015-7103K140951
2023-6744FEI 2081055
2015-4833K041414
2026-8521FEI 405
2018-3946K122158
2019-8683K152970
2021-6155Form FDA 483, FEI 3008592544
2015-8519K042500, K052445
2017-5784K102595
2026-1214EIR, FEI 1045125
2020-7507K193424
2021-2000K112478
2016-1673K082185, K092271, K110943
2020-7684Form FDA 483, FEI 3011277306
2023-2636Form FDA 483, FEI 3002524000
2024-7949Form FDA 483, FEI 3004079469
2020-2515P970051
2023-2986Form FDA 483, FEI 1819470
2024-2471K052858
2019-1401K050812
2016-3354K851086
2024-3885Form FDA 483, FEI 1000119368
2014-9282K021932, K051296, K080398
2018-4784K850754
2025-2911Form FDA 483, FEI 1150053
2018-8672K101791
2015-10247K131433, K132108
2024-7338K182618, K203343, K210034
2015-1334K121891
2017-9309K160226
2018-9950K820193, K926565, K930822
2025-14164Form FDA 483, FEI 3001814065
2017-7259K152332
2015-7385K141952
2024-1952Form FDA 483, FEI 3012112573
2016-6592K130991
2014-8122K810271
2018-9546K042026
2016-3947K121795
2024-6459P020014
2026-8127Form FDA 483, FEI 3011651103
2015-4494K122295
2020-7001K081140, K102595, K141637
2019-1569K183704
2026-5207Form FDA 483, FEI 3010508078
2019-2983K180396
2015-10228K122086
2020-6711K140685
2018-4173K172258
2018-9885K182983
2025-12561K212630
2020-2582K112786
2025-10734K833475
2025-11342Form FDA 483, FEI 1000111202
2025-8891Form FDA 483, FEI 3004773609
2021-6327K153399
2019-6322Form FDA 483
2024-5649K133191, K221791
2017-2600K063465
2022-2020K820723
2018-6978K954331
2017-1163P060028
2026-6108Form FDA 483, FEI 3004181533
2025-10343FEI 3020929899
2023-5480Form FDA 483, FEI 3003024548
2020-7180Form FDA 483, FEI 3003079707
2023-2964Form FDA 483, FEI 3015549533
2024-7777Form FDA 483, FEI 1000305746
2019-7711K093460, K101995, K110212
2020-2199K032522, K112470, K142596
2022-4383K980298
2017-5021K051812
2015-177K002154
2023-5531K181977
2018-9219K113356
2015-1210K051093
2021-365FEI 1924066
2025-6995K140714
2025-13781Form FDA 483, FEI 1000547811
2015-6305K151340
2026-1958Form FDA 483, FEI 3009096682
2024-7951Form FDA 483, FEI 3002808845
2014-8320K862653
2019-10550K103429
2018-4389K173035
2022-6707Form FDA 483, FEI 1220423
2015-7332K022774, K132031
2023-1848Form FDA 483, FEI 1937310
2024-6613K192674
2018-506K112605
2016-2229P930016
2020-8821Form FDA 483, FEI 3002626007
2023-5019K223726
2024-8083Form FDA 483, FEI 1219205
2015-5567K070425
2025-11660FEI 3001642379
2019-9968K181965
2016-3918K160044
2024-5898K202106
2021-6114K171969
2017-1646K142505
2015-7062K071827
2026-8478EIR, FEI 3005042488
2015-1472K110661
2023-4241K120781, K201077, K201188
2018-1170K170568
2023-5822FEI 3005949964
2019-10046K023254, K023579, K110212
2023-9910Form FDA 483, FEI 3002808086
2019-6747K033622, K050738, K113231
2026-8267Form FDA 483, FEI 3000717944
2016-888K133800
2026-7180Form FDA 483, FEI 3011292417
2023-3378K193067
2021-5666K203215
2023-10229Form FDA 483, FEI 2021710
2023-10884Form FDA 483, FEI 3009600098
2022-6996Form FDA 483, FEI 3008816697
2025-1091K893820
2025-14340K232524
2022-8642K101589
2025-9353K113106
2017-1200P020056
2025-7165P960009
2016-8471K101077
2025-11187Form FDA 483, FEI 1417519
2016-7111K021349
2016-10385K070876
2022-5697K220867
2019-303K181642
2021-480K191252
2017-5652P040034
2022-1457Form FDA 483, FEI 3004161147
2015-2690K023805
2022-1642Form FDA 483, FEI 2244019
2014-8842K070270
2015-5237K141770
2020-5158K171239, K200952, P190016
2022-5574FEI 3007596547
2020-7122FEI 1841
2026-6225K922770
2024-6622Form FDA 483, FEI 1000121050
2014-8535K920788, K922318
2015-9627K951123
2015-5028K030411, K030925, K051301
2021-3848K022902, K093363
2024-4246K222581
2018-171K163579
2025-4209Form FDA 483, FEI 3015282703
2021-6109EIR, FEI 1221084
2024-7385Form FDA 483, FEI 3004142400
2026-9371Form FDA 483, FEI 1220908
2023-11408K230385
2019-1883P820056
2023-5717Form FDA 483, FEI 3017397434
2014-9098K032821
2017-2020K140662
2016-8629K061774, K072685
2017-6367K140939
2021-6903K053052
2016-9773K921820
2025-11455EIR, FEI 3003995201
2016-4134K153293
2015-6628K890598, K902489
2017-9395K092283
2019-7191K143630
2020-2314K022447, K072862, K093510
2026-8205Form FDA 483, FEI 3001675293
2023-597Form FDA 483, FEI 3015200642
2024-9659Form FDA 483, FEI 3006190476
2026-7109Form FDA 483, FEI 3011175548
2024-1493Form FDA 483, FEI 1039131
2024-7696Form FDA 483, FEI 3000957797
2026-8047K252950
2020-7435K112177, K162438, K162642
2026-9349FEI 3008642652
2020-2345P170008
2023-9695K771368
2025-330K162751
2022-2669FEI 1000117344
2023-5781K173408
2022-5772K102101, K123605
2019-1472K990144
2021-1097K183515, K183644, K191597
2017-946K162895
2025-2862Form FDA 483, FEI 3012664855
2023-1026Form FDA 483, FEI 2243057
2023-2234P150017
2022-167K102182, K112114, K140264
2023-2233P150017
2018-9537K030684
2023-5259FEI 2648650
2017-5525K030882
2019-10224K183282
2025-13116Form FDA 483, FEI 3002897187
2020-5953K142706, K142711, K143743
2016-524K142552, K151954
2018-9460K170918
2015-5049K943272
2016-7327K050225
2024-3284K221683
2023-10367Form FDA 483, FEI 3014534
2023-9561Form FDA 483, FEI 3001551180
2014-9266K924018
2015-7511K141926
2023-4868EIR, FEI 3005210579
2018-5828K091216
2023-4609EIR, FEI 3007536356
2023-5984K960224
2023-9511Form FDA 483, FEI 3004014634
2017-5993K023892
2024-8123K203343
2025-3345K191332
2022-1440K152723, K172566, K181974
2018-7684K811409
2021-1195K831793
2018-6391K901625
2021-6793K093647, K120917, K122316
2022-7685Form FDA 483, FEI 5975
2025-9072Form FDA 483, FEI 2183890
2018-5220K103340
2017-46K160511
2022-7659EIR, FEI 3005990076
2023-9757Form FDA 483, FEI 1000124207
2014-9343K050337
2025-803K941189, K994024
2021-4905P990033
2026-7908P200022
2016-4270K150689
2022-5869K192324
2017-9671K911101
2015-8088K942533
2023-4586K150621
2024-6190Form FDA 483, FEI 3012883202
2020-8554FEI 1000513101
2023-3169Form FDA 483, FEI 3010355846
2016-6708K093126
2020-3673P180046
2019-7411K082037
2022-115K211401
2016-1066K100099
2015-4571P080027
2017-9633K143033
2021-4076P030028
2025-11844K200667
2023-4199Form FDA 483, FEI 3001236129
2016-1185K123955, K141520, K151917
2026-8794Form FDA 483, FEI 1833310
2018-10341K173281
2022-8640K101092
2016-6933K082205, K993553
2026-9368Form FDA 483, FEI 3008642652
2026-5771Form FDA 483, FEI 3002783962
2016-8516K791619
2015-2398K142006
2018-485K993900
2018-2735K863815
2017-8050K160064
2016-2631K981095
2021-2336FEI 3017636713
2026-8322Form FDA 483, FEI 3003072803
2017-9764K103767
2021-5621Form FDA 483, FEI 7300
2024-9123K233539
2026-9327FEI 2112020
2019-5777K101182
2023-2716K010139
2017-6211K162572
2024-5661Form FDA 483, FEI 3014408327
2015-2293K130847
2019-108K142178
2023-4761Form FDA 483, FEI 3001092088
2018-9706K110605
2017-6648K951228
2017-126K780003
2023-9999K042937, K082446
2019-5214K183592
2025-910Form FDA 483, FEI 1000283452
2023-2809Form FDA 483, FEI 3004388281
2020-3405K102333
2017-6130K832609, K840335, K841215
2018-5970K170574
2025-863K152665
2022-5149K011168
2016-4337K033634
2019-12059K060041, K091156, K951302
2016-4191K941327
2025-2452K213657
2022-6196K131044
2020-5488K152115
2023-8514FEI 1219592
2020-4676K200662
2025-3808Form FDA 483, FEI 3001640191
2025-3089K182964, K191369, K191998
2024-769EIR, FEI 3012448339
2015-387K991864
2025-14176Form FDA 483, FEI 3010002722
2022-8489Form FDA 483, FEI 3005798905
2018-4558K151422
2025-9061Form FDA 483, FEI 2219920
2021-1315Form FDA 483
2016-8615K160818
2019-4887K140841
2023-2732K080355, K140054, K193483
2016-1703K831516
2020-3643K161339
2022-7287K221047
2024-232Form FDA 483, FEI 1000111204
2019-11908K072113
2017-8151K003395
2023-45K150409
2014-9145K083335
2018-2648K173760
2020-3823K181838
2025-13432Form FDA 483, FEI 3015178562
2022-7042Form FDA 483, FEI 3010131789
2017-979K133602
2021-8646K192732
2026-7391Form FDA 483, FEI 3001611427
2022-3413K990658
2017-1396K080376
2023-10302K214048
2021-5503K800999
2016-8561K032885
2023-8539K021481, K152494, K213815
2020-2762K072618, K093447, K120242
2024-6453Form FDA 483, FEI 3003059934
2018-2427K171186
2022-7764Form FDA 483, FEI 3013215912
2021-4421K202599
2016-5263K082385
2021-8871Form FDA 483, FEI 3003166194
2020-6777K201010
2021-3338K202320
2025-2871Form FDA 483, FEI 3015045325
2015-5594K112822
2015-9559K941691
2018-8664K110193
2017-757K852200
2026-5929K250487
2018-787K021317
2019-4061K132066
2016-9664K894184
2015-1010K123128
2016-6078K040687, K052118, K061051
2019-2594K012651, K101702
2015-4806K851818
2022-3562K203774
2016-5673K083169
2025-11396Form FDA 483, FEI 3006349554
2017-3912K042032
2025-349K200278
2015-9989K124041
2017-10116K001408
2023-10540P100021
2020-1941K060057
2016-333P900033
2015-5314K031327
2015-2431K123229
2021-7643FEI 3009600098
2015-4103K101801
2022-4406K072002, K791307
2017-4251K043204
2022-1948K212659
2014-8506K051772, K060745, K111338
2019-4081K160992, K162512, K163415
2024-9627Form FDA 483, FEI 3001576173
2015-1866K052396
2023-9950K170790, K171671, K173972
2018-5056K130366
2017-2055K122234
2019-99K130312
2025-6963K172234
2016-477K130857
2019-3026K183353
2022-5170K021827
2025-1923K072215
2015-5208K030254
2016-816K002095
2015-3464K964325
2026-5384Form FDA 483, FEI 2648729
2023-4850FEI 1030489
2019-3908K140557
2017-5058K800494, K802123
2017-7689K112308
2019-1619K130921
2021-8568K202751
2025-3966Form FDA 483, FEI 3016181636
2022-1865FEI 3002676602
2025-12278Form FDA 483, FEI 3002808845
2018-9698K020530
2026-4896K923364
2022-5934K171237
2026-4419Form FDA 483, FEI 1011574
2017-7194K153729
2019-8740K101851
2019-11932K191280
2023-8940Form FDA 483, FEI 3014162263
2021-5565K140726
2022-5696K200596
2023-5895K222519
2019-6039K071468, K112930, K142408
2020-7146K110815
2023-9143Form FDA 483, FEI 3001605696
2014-8716K081076
2025-268FEI 3007774465
2015-8487K122237, K131113
2026-4583Form FDA 483, FEI 3001592626
2021-607K183000
2019-4029K970594
2016-1098K991502
2019-6153K162314
2026-7459Form FDA 483, FEI 3008776287
2016-2995K072687
2020-6748K170210
2019-7347K173448
2017-5756K082586
2015-8705K922440
2023-6529Form FDA 483, FEI 2914537
2015-245K141102
2021-5709K071934
2021-955K182036
2025-9618P210007, P970003
2026-8327Form FDA 483, FEI 3003072803
2015-3949K102274, K113597, K132232
2019-11963K141682
2016-3204K101128
2024-1804K222689
2014-8106K123169
2021-4587K110823, K171671
2022-7439Form FDA 483, FEI 3009492128
2014-8511K934440
2023-4407Form FDA 483, FEI 2026424
2019-11279K984552
2025-7213K905831
2026-1713Form FDA 483, FEI 3011575197
2025-11449Form FDA 483, FEI 3014534
2024-10125K992917
2025-2258K944326
2019-3271Form FDA 483, FEI 5539
2014-9133K040324
2018-1427K942321
2016-5604P030053
2023-4464K062672, K071178, K103595
2017-649K123731
2016-777K130651
2015-105K955936
2022-3560K191080
2022-5701K112423
2015-1498K130167
2017-174K161921
2018-7659K170658
2025-7406K031099, K043574, K060381
2018-4390K843757, K843760
2026-8132Form FDA 483, FEI 3035371452
2022-6264FEI 3008875470
2020-7671K031018, K092221, K183688
2023-4324Form FDA 483, FEI 1250045
2024-10465Form FDA 483, FEI 3012267350
2020-7529Form FDA 483, FEI 3002087856
2025-4437Form FDA 483, FEI 3006749547
2016-5260K122217, K133821, K143203
2024-1942Form FDA 483, FEI 3004167720
2017-7156K040238
2023-2281K220567
2016-2640K141785
2019-1846K051665
2024-3317K160414
2015-2122K133077
2021-6507Form FDA 483, FEI 3007772056
2024-3522Form FDA 483
2025-3905Form FDA 483, FEI 3026523692
2018-9690K131177
2020-2411K032833, K123795
2018-8068P150047
2026-6605Form FDA 483, FEI 3035371452
2019-9726K153345
2026-5103Form FDA 483, FEI 1000110937
2020-4145K143752, K182964
2018-5471K161212
2023-11466Form FDA 483, FEI 3010676138
2024-3216K171294
2024-1031K211218
2021-3134K193417
2017-4273K161457
2019-4628K934880
2018-1833K170774
2015-8607K912662
2023-6783K212815
2024-9668Form FDA 483, FEI 2021687
2025-8225Form FDA 483, FEI 3002690289
2017-3816K032818
2025-7225Form FDA 483, FEI 2124143
2019-5055K981415
2024-2279K811404, K820128, K870027
2023-8861Form FDA 483, FEI 2939653
2016-4124K141119
2018-2218K142432
2015-3841K132031
2019-2538Form FDA 483, FEI 3009091796
2020-5771K162233, K191832
2026-7568K060407, K063715, K072152
2019-5794K120301, P150003
2025-3948Form FDA 483, FEI 3012422693
2018-5435K161355, K173085
2016-7783K021792
2017-8585K140178
2022-1096K122660, K173619, K180474
2016-4752K060012, K071227, K123632
2020-6068K042970
2026-4391Form FDA 483, FEI 3009566827
2019-10655K060713
2025-10102Form FDA 483, FEI 3005949964
2021-4496K210025
2017-8777K170155
2021-3447K093919
2020-4717K172851
2018-4388K123907
2017-1615K160942
2017-2238K972964
2023-2955K111202
2017-9396K152055
2025-11393Form FDA 483, FEI 3004380893
2022-4431K210478
2023-4633K110623
2025-11547K934053
2023-3756Form FDA 483, FEI 3007608536
2020-6439K153359
2024-1713Form FDA 483, FEI 3012630624
2017-5556K153080
2021-2711K100831
2020-2861K183603
2025-11804Form FDA 483, FEI 3011430913
2017-3003K143496
2015-9556K931621
2025-12375FEI 3021970859
2016-4725K113036
2026-4360EIR, FEI 3003790304
2019-8595K090725, K091051, K143496
2023-7889FEI 3011270181
2017-2906K072836
2016-9224K140575
2016-6670K991426
2025-11173Form FDA 483, FEI 1045125
2017-648K103745
2020-2423K090801, K113658, K162219
2016-623K990276
2016-6324K110727
2015-2025K092886
2023-4178K122619
2018-7774K111442
2025-10746K823176
2025-1084K913485
2025-12597K161043
2014-9789P060019, P130026
2015-168K023905
2015-298K042455, K080079, K120035
2014-8240K142408
2022-8512Form FDA 483, FEI 3016784205
2015-9009K092981, K132313
2021-2282K203782
2018-569K014274
2025-11868Form FDA 483, FEI 3011292417
2018-2203K151179
2023-10545FEI 5615
2023-10657K203737
2023-6050Form FDA 483, FEI 3004170064
2017-1345K160644, K162511
2025-10663Form FDA 483, FEI 2124143
2022-2713FEI 3011400126
2019-10564K130541
2026-5590K242376
2024-6628Form FDA 483, FEI 2411192
2020-8566Form FDA 483
2015-4436K140516
2022-1587Form FDA 483, FEI 3015528146
2016-1326K112411, K123259
2026-4707EIR, FEI 3003112432
2021-947K131278
2022-1701K040317, K955529
2018-9565K173871
2024-1631K231325
2021-4399K170784
2021-3446K093647
2021-3012P020056
2023-6850Form FDA 483, FEI 3012157621
2022-8491Form FDA 483, FEI 3011175548
2025-11538K203267
2015-1850K023135
2024-1777K219228
2025-3498Form FDA 483, FEI 3004380247
2022-4687FEI 3010594257
2024-6166Form FDA 483, FEI 3000241849
2018-698K090242, K091729
2022-8177Form FDA 483, FEI 3013756523
2015-1755K031920
2019-7496K062163, K133226
2023-11119Form FDA 483, FEI 1213643
2023-6204Form FDA 483, FEI 3017884860
2020-5147K073581
2015-9742K061373, K090661
2018-10096K152773, K161772
2014-9398K092227, K101609, K113273
2025-7230K191450, K193371, K193642
2022-6050K142432, K190047, K200482
2025-12001Form FDA 483, FEI 3003315146
2021-4983K003227
2020-2885K191911
2024-5582K955063
2024-278Form FDA 483, FEI 3007118747
2024-1992Form FDA 483, FEI 3015272694
2023-5780K171183
2015-2673K001334, K001773, K032232
2025-11377Form FDA 483, FEI 3002807108
2016-3146K141827
2022-1639Form FDA 483, FEI 3004452289
2023-6248K162843
2016-5732K120800
2015-10201K050770
2023-4666K171646
2021-1800K103563
2018-9549K092032
2023-3270Form FDA 483, FEI 3010120135
2018-5656K924165
2021-4542K193473, K200240, K200795
2021-3966EIR, FEI 3002754162
2014-9178K023961
2017-5185K031206, K071673, K110772
2016-6343K112277
2024-7637K232686
2019-3222K063435, K820193
2016-4234K071230
2025-2826P040034
2019-90K131596, K161237, K163070
2017-5753K964224
2023-3812FEI 1313525
2019-8748K002351
2018-7537K160026
2023-3607Form FDA 483, FEI 3003752255
2016-4896K112208
2024-8177K230846
2024-5223Form FDA 483, FEI 3009306483
2021-6797FEI 1000139754
2023-11558Form FDA 483, FEI 1318843
2016-2863K152009
2026-1849Form FDA 483, FEI 3002821211
2015-5020K051670
2022-220K173119
2022-893K133724, K861730
2016-4082K151650
2019-5053K100104
2015-4180K133987
2025-179Form FDA 483, FEI 3015979371
2017-5075K162603
2020-4100K082315
2022-7767Form FDA 483, FEI 3013649990
2023-5237Form FDA 483, FEI 3004737415
2023-7182K181205, K221658, K221834
2023-7439K223548
2026-4534Form FDA 483, FEI 3860
2017-2629K062991
2019-8298FEI 5822
2025-10671EIR, FEI 3007143268
2016-7698K043557, K051664
2023-7849K181686
2024-9665Form FDA 483, FEI 3016429887
2015-3477K131681
2017-2393K032904
2019-1008K073468
2016-3078K041194
2021-1461K200717
2023-9272Form FDA 483, FEI 1316463
2017-1644K151359
2026-5099Form FDA 483, FEI 3015282703
2017-2094K162895
2021-3768K060978
2022-8541FEI 3005916315
2014-8862K120582
2023-748K152127, K181038
2019-4621K151185, K152519
2018-7683K163277
2025-4304Form FDA 483
2026-4725K162193
2016-4696K143499
2017-5014K143169
2023-6444Form FDA 483, FEI 3004473533
2018-1422K173119
2026-5733Form FDA 483, FEI 3034735187
2014-8215K961725
2018-5842K061615, K110715
2023-5481Form FDA 483, FEI 3002970979
2025-7443Form FDA 483, FEI 3011277653
2019-3289K151635, K161773
2025-834K012009
2023-10208Form FDA 483, FEI 3012250536
2014-9428K033364
2025-3874Form FDA 483, FEI 2242327
2016-3061K112770
2023-11308K081122
2018-5525K101749, K112711, K173542
2022-3911K130283
2025-14339K233648
2020-5618K170155
2025-10177Form FDA 483, FEI 3014534
2023-6426K211228
2022-6446K203503
2018-10026K161384
2017-2422K123588
2017-960K914524
2019-10142K163628
2023-2269Form FDA 483, FEI 3013445959
2026-9040Form FDA 483, FEI 1000138377
2022-8112K220230
2024-4838Form FDA 483, FEI 3015134004
2026-9345FEI 3008642652
2016-5610K030714, K033514, K131660
2026-1760Form FDA 483, FEI 3030595020
2022-6896Form FDA 483, FEI 3007225376
2016-9689K081509, K120561, K131278
2016-8708K110739
2017-3794K151650
2021-8412Form FDA 483, FEI 3005862821
2022-4686FEI 3007738819
2025-1286Form FDA 483, FEI 1045125
2025-8580Form FDA 483, FEI 3004965821
2021-3776FEI 1000535235
2024-2809FEI 3020929899
2023-8862Form FDA 483, FEI 3001003398
2020-265K193375
2016-6734K140561
2022-383K203735
2015-8687K063166
2019-4383K024006
2015-1981K122219
2015-9466K133057
2016-10329K121197, K133701
2024-9298Form FDA 483, FEI 1825527
2015-759K140464
2025-1915Form FDA 483, FEI 3015980493
2023-3810FEI 1313525
2025-3887Form FDA 483, FEI 3004753838
2016-708K111077
2025-3232EIR, FEI 1824206
2022-7226K201881
2021-6857Form FDA 483, FEI 3010470577
2017-6405K122422, K160437
2016-8664K130744
2015-3936K063722
2017-4439K130845
2024-18Form FDA 483, FEI 3005382058
2018-10147K043596, K103319
2015-98K132560
2016-6474K103646
2015-2875K130802
2016-399K012937, K971675
2015-3561K140575
2020-1719K162438
2018-1700K153642
2014-8630K100820
2026-9134Form FDA 483, FEI 1032500
2022-8714FEI 3005641545
2023-6659Form FDA 483, FEI 1819470
2017-4990P810046
2024-10165K241361
2024-8294K233253
2016-7542K150707
2018-4185K131305, K150861, K162172
2025-10740K982999
2017-8794K964622, K980866
2026-6098Form FDA 483, FEI 3008595179
2020-8607K071732, K091217, K103784

About this dataset

The FDA publishes logs of the Freedom of Information Act (FOIA) requests it receives. Orca1 links each request to the FDA establishments (FEIs) and premarket submissions it names. Requester names and the request text are not shown.

Source: U.S. Food and Drug Administration (FDA), FOIA request logs