Data catalog

FDA FOIA requests

About 15K records

More records

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

2026-8496FEI 3011649314
2016-7861K981034
2025-4021K232162
2025-14317Form FDA 483, FEI 1025483
2019-11554K192245
2017-3705K162532
2019-6212K161424
2018-5185K032104
2017-5357K131260
2018-7466K083552
2015-133K103113
2023-5234Form FDA 483, FEI 1218813
2023-5903FEI 1039215
2022-3977K093520, K153229, K153283
2025-3677K210544
2023-4535K951919
2025-7938Form FDA 483, FEI 3001677091
2023-7130FEI 1220246
2019-1586K163288
2025-1962Form FDA 483, FEI 1000120743
2022-4852K211678
2023-2241FEI 3011053282
2019-1203K003458
2026-7921Form FDA 483, FEI 1419377
2016-8522K153636
2016-866K153088
2016-1654K141081
2016-233K113066, K143086
2019-10173K811528
2016-1403K092359
2018-4798K972382
2018-8540K061993
2024-7991EIR, FEI 1413475
2023-11521K092721, K172688
2017-5574K162237
2020-7262K913344, K914746, K924754
2019-2766K083608
2023-5336Form FDA 483, FEI 2182207
2016-4625K021288, K023282, K023283
2019-36K181863
2020-5586K010485, K063217, K152765
2025-12323FEI 3033307563
2017-5926K113398
2023-10414Form FDA 483, FEI 1000560772
2016-5572K053547
2015-7880K150962
2016-9161K083621
2019-7239K092227, K101609, K113273
2023-5359K172633, K211347
2017-7019K130167
2018-9874K171323
2026-5493Form FDA 483, FEI 3010806039
2026-4951Form FDA 483, FEI 1718912
2015-7545K134005
2019-11872K163451
2016-6875K121993
2023-5707FEI 3006073153
2023-326Form FDA 483, FEI 3009424883
2018-4430K151123
2016-4338K003250
2016-6309K153048
2025-1172Form FDA 483, FEI 1819470
2026-8583Form FDA 483, FEI 3002806960
2019-8739K052155
2015-8131K092944
2022-2775K901040
2016-8639K130040
2017-213P060028
2020-3560FEI 4442
2025-1072K180451
2015-7384K143752
2015-1978K955672
2024-11257Form FDA 483, FEI 1218882
2018-5759K142801, K160338, K163507
2019-10547P910071
2025-11258EIR, FEI 1317628
2024-5750K910536
2021-8532FEI 1000354384
2016-5742K020234, K020235, K051321
2015-2241K040973
2020-3479K191998
2025-3579K230037, K230167
2024-11218Form FDA 483, FEI 5539
2023-4847FEI 1000122786
2015-7641K110459
2016-8523K160239
2018-1302K120961
2017-1480K965120
2019-2076K180643
2019-6038K083833, K120092, K842607
2024-10327K242382
2019-6239K161555
2018-6864K110268
2025-1658K143659
2023-8859Form FDA 483, FEI 3001451797
2018-6476K170551
2018-1376K172268, K172623
2025-14040Form FDA 483, FEI 2182681
2023-8096K012943, K060540
2018-5906K163696
2022-808K120902
2016-3302K070015
2023-10505K173841
2017-3561K102973
2021-7940FEI 3002095335
2016-8521K153674
2023-8223K182870
2014-8050K080337
2016-8914K140828
2023-1233K090019, K180421, K200878
2019-1138K173281
2017-10282K172520
2024-7952Form FDA 483, FEI 3011158388
2025-2500Form FDA 483, FEI 3005695808
2014-9048K140162
2022-8119K926424
2026-5046Form FDA 483, FEI 3001413302
2016-1282K063509
2018-839K122172, K172677
2016-2051P960053
2026-6655Form FDA 483, FEI 1032500
2018-5486K160555
2015-4808K851816
2015-1444K132437
2016-9969K133317
2021-4808K052989, K142932, K171566
2022-5441K182102
2017-2146K150154
2014-8584K082761
2025-3075Form FDA 483, FEI 3015892095
2017-6455K141617
2015-8338K142774
2021-4258K952566
2019-2858K123813, K141634, K180560
2023-9005K221585
2025-10937Form FDA 483, FEI 3021159346
2015-5161K030611
2019-5022P080032
2016-6417K993592
2015-9265K028830
2025-12424Form FDA 483, FEI 3000214934
2025-864K221813
2022-7551K202104
2021-3383Form FDA 483, FEI 3011680766
2026-9394FEI 1218058
2026-5625Form FDA 483, FEI 3005949964
2022-4226K220641
2022-8471K122702
2014-8633K093565
2019-11938K150237
2015-2693K933048
2023-6526K013672
2017-9380K083153
2018-377K170960
2015-4807K851817
2024-11138Form FDA 483, FEI 1416980
2015-9056K132169
2017-224P030053
2015-760K991139
2016-8558K073564
2015-3623K033052
2021-1478K203247
2017-7879K152266, K161602
2014-8108K122202
2022-3784K011533
2025-8872Form FDA 483, FEI 2083373
2024-340Form FDA 483, FEI 1833387
2023-4634K040417
2020-5309P190021
2015-8139K100434
2022-3919FEI 1000117004
2017-2207K161311
2019-91K052835
2023-151K013056, K152533
2019-583K142036
2018-9810K820227
2022-6393K130649
2023-7166K160176
2025-12602Form FDA 483, FEI 3009166014
2023-5789EIR, FEI 3006258094
2026-4905K251517
2023-7794FEI 3007208259
2022-8570K192880
2015-2156K120454
2023-742K210162
2024-6894Form FDA 483, FEI 3007208829
2021-5231K151793, K163190
2019-2373K002830, K140780, K141983
2016-8865K160783
2016-8302K020435
2020-4755K183598
2022-2783K211079
2018-4954K100488
2022-948Form FDA 483, FEI 4395
2025-10914K173675, K180205, K181206
2024-6107K191394
2019-6224K024008
2017-5003K160179
2018-9109K132037
2015-5067K860158, K883780, K960728
2019-6752K030281, K111695, K790738
2019-274K172819
2024-1433Form FDA 483, FEI 3010221586
2021-3845P980040
2024-4373FEI 5513
2019-2045K101571
2021-5668P050024
2025-7867K230794
2020-7145K110816
2025-13144K230856
2023-7215Form FDA 483, FEI 2242327
2024-3955K923996
2026-7757K261068
2019-11263K151482
2017-691K150852
2014-9249K895159
2016-1803K152958
2016-10402K042515
2015-6612K062265
2018-9125K103429
2017-7204K121667, K160823
2021-6978K161506
2017-10241K160339
2020-4844K193473
2025-7286Form FDA 483, FEI 4395
2019-2125K172418
2023-11425Form FDA 483, FEI 1218813
2020-1709K001337
2025-11487Form FDA 483, FEI 3010413216
2026-8948Form FDA 483, FEI 3001451489
2024-1714Form FDA 483, FEI 2122870
2020-111K132809
2024-8982P140011
2018-5319K173862
2016-4033K152055
2025-12120Form FDA 483, FEI 3000241849
2015-7390K143752
2019-10543P170004
2014-9132K022894
2018-6927K884790
2022-6659Form FDA 483, FEI 2433012
2018-4809K090217
2016-8157K102063
2023-5609K991702
2017-7769K060804
2021-5619K203192
2018-5529K021049, K024012
2023-6356K103561
2023-5961K990519
2023-1948Form FDA 483, FEI 3013445959
2017-9376K150462
2014-8015K131337
2019-10658K080223, K100989, K142054
2024-5739K150786, K160417, K180237
2026-8131Form FDA 483, FEI 3016548959
2025-3412Form FDA 483, FEI 3007108578
2024-8791Form FDA 483, FEI 3000204191
2023-2822Form FDA 483, FEI 3011660785
2019-7768K002024
2015-3629K142203
2020-5495K170551
2019-11273K161768
2025-2737K243838
2023-4702K101262
2016-8729K141603
2018-5632K172079
2017-3876K162513, K163253
2026-7111Form FDA 483, FEI 3013445959
2015-7166K013559
2025-13040Form FDA 483, FEI 3008312728
2020-1515K182388, K191774, K191823
2022-866EIR, FEI 3007412809
2014-9336K020399
2021-499Form FDA 483, FEI 3004161147
2015-60K040974
2023-4981Form FDA 483, FEI 3005566046
2019-4923K922123
2017-3544K010094
2024-3143Form FDA 483, FEI 3010867648
2024-7488Form FDA 483, FEI 3009711592
2019-42K072251
2023-8899P010047
2024-8659Form FDA 483, FEI 1720129
2018-5951K101052
2024-6082EIR, FEI 1036832
2017-390K110068
2023-4121K213794
2021-1463K183370
2014-9058K140472
2019-6271K051772, K060745, K111338
2020-2577K052155, K083856, K110820
2024-6102Form FDA 483, FEI 3016947689
2016-8587K093594
2020-5378K140552, K141883, K151929
2023-8372K201560, K901202, K902305
2025-2451K100593, K202551, K981531
2017-2308K960415
2015-10196K051284
2022-8194FEI 1000120578
2017-9179K172881
2019-541K951104
2025-13838Form FDA 483, FEI 3001237145
2018-3437K952877
2016-8087K142106
2023-5060K171343
2024-3185FEI 1181121
2019-2518K153392
2019-8743K142706
2024-260K191680
2025-72FEI 3430
2018-7532P980024
2020-6552P030017
2024-748Form FDA 483, FEI 1000087290
2025-1369K212519
2015-1313K033448
2024-224Form FDA 483, FEI 1120890
2021-7012K110472
2019-3546K051525
2021-3296K060408
2025-2927Form FDA 483, FEI 3008910197
2024-8743Form FDA 483, FEI 1413475
2016-4196K110701, K141410
2021-303K852326, K852920, K853643
2023-10874K052615
2016-2755K042506
2015-8995K142679
2020-6687K183195
2016-4561K150802
2017-222K082293
2021-7441FEI 1000477302
2018-7116P080025
2021-6882K896622
2023-3991K153502, K200776, K202079
2018-5929K042613
2014-8877K070964, K120743
2020-3959K172955
2025-9098Form FDA 483, FEI 3002904345
2024-3930Form FDA 483, FEI 3006215390
2023-3064K221841
2023-5678K201590
2026-7939EIR, FEI 3008731457
2026-6610Form FDA 483, FEI 3004139819
2017-6098P050044
2026-8485Form FDA 483, FEI 3009717300
2014-8346K081285
2019-8850K042290
2016-8930K161148
2024-6511K031099, K043574, K140866
2016-1323K063233, K063697, K070179
2024-6108K223144
2020-4473K903607
2015-8709K012098, K953969
2015-2894K122982
2024-3870K191102
2015-9921K003915
2023-10592K003867
2017-5162K163058
2017-9049K153591
2023-7136FEI 1220246
2015-3896K123985
2015-9976K081076
2015-1701K131559
2019-8957K152319, K173760
2016-8638K122817
2014-9126K122288
2025-8946Form FDA 483, FEI 1000071265
2020-5976K180904
2016-6448K893396
2018-499K113732
2021-4786FEI 3011623994
2015-552K122474
2015-2153K082176
2020-4708K191605
2018-2722K171646
2024-8114FEI 3003374183
2026-4934Form FDA 483, FEI 3013559620
2024-7700Form FDA 483, FEI 3006191977
2023-3319Form FDA 483, FEI 3009973336
2016-1240K023830
2015-5171K883239, K900295
2026-5101Form FDA 483, FEI 3001237796
2017-1934K062616
2019-9712P030053
2023-10413Form FDA 483, FEI 3019101334
2021-7517P160050
2019-6671K160006, K160864
2019-4985K122432
2022-4662K041007
2022-5439K133538
2026-9332FEI 3003793491
2016-7627K933772
2015-2934K100341
2023-9224Form FDA 483, FEI 2027046
2020-3198K183688
2023-10463K222743
2014-9919K123731
2017-4248K072053
2026-9235K140078
2024-6115K072002, K121710, K151589
2022-707K103429
2018-8656K081740
2024-5856K082890, K181991, K191546
2019-10063K153049
2016-4385K130744, K133338, K141153
2021-8250K073567, K120370, K130899
2021-8869K162191
2021-5839K914220, K914241
2025-9400Form FDA 483, FEI 3000247987
2017-9895K963816
2016-3232K010998
2017-9024K160602
2015-9820K022732, K050004, K983393
2025-10365K031891
2024-11274P900009
2018-2527K173447
2016-4641K151692
2025-11884Form FDA 483, FEI 1045254
2025-14180Form FDA 483, FEI 1000306093
2015-9555K945303
2024-3008K130995, K161296, K210310
2022-5860K051309
2023-3668K092622, K160136, K171237
2025-3849Form FDA 483, FEI 3003310366
2025-8477K955506
2016-1959K151911
2016-4924K111202
2018-77K141865
2023-10211Form FDA 483, FEI 1000123978
2015-8311Form FDA 483
2024-4862Form FDA 483, FEI 1000307073
2019-11830FEI 1110315
2015-5701K150137
2025-1088K903763
2023-10258K163046
2019-8744K142711
2017-5683K120023
2018-5748K040836
2023-6201Form FDA 483, FEI 3006076009
2017-4845K142807, K170648
2023-47K210365
2019-8416K171637
2019-11931K093993
2015-6754K981916
2026-9072Form FDA 483, FEI 3012908140
2021-304Form FDA 483, FEI 3010123655
2020-8131K944393
2024-6183FEI 3005669319
2022-2699K160031, K203192, K910624
2021-6115K171989
2023-3761Form FDA 483, FEI 3013757456
2023-2328K200232
2022-8138Form FDA 483, FEI 3010131268
2024-6583K163109
2014-9976K121916
2025-2632Form FDA 483, FEI 3002757762
2020-7176Form FDA 483, FEI 3002579136
2015-6212K022002
2015-8276K150641
2018-10104K040211
2019-10077P050038, P170012
2019-3932K091461
2019-1632K181180
2019-104K140132
2022-2409Form FDA 483, FEI 1000125255
2023-328Form FDA 483, FEI 3021570645
2017-4997K162047
2022-2849K203714
2025-10744K853152
2022-5433K172754
2015-3620K072201
2017-5466K163401
2015-9417K151324
2024-8835FEI 3002808212
2023-4534K980755
2025-12410Form FDA 483, FEI 1219205
2026-5003Form FDA 483, FEI 1922337
2017-3457K150174
2025-11495Form FDA 483, FEI 3002806503
2015-2936K111773
2021-4093K103031, K120511, K170175
2022-7554K102581
2024-1281Form FDA 483, FEI 1000125771
2020-444K062963
2025-7018K230013
2017-8468K150625
2021-726K151499, K163623, K170438
2018-6957K172740
2026-5281Form FDA 483, FEI 3010892830
2021-4616P860004
2018-628K024322
2023-3762Form FDA 483, FEI 3002840531
2021-3886K170629
2025-8758Form FDA 483, FEI 3009437400
2025-7202K073652
2014-8518K141865
2023-7502K222487
2023-3467EIR, FEI 1025114
2017-5057K143675
2018-513K111818, K120349, K121812
2025-2926Form FDA 483, FEI 3024812789
2015-3091K920873, K935403
2019-2096K943349
2024-7230FEI 3007208829
2024-10658FEI 3008452825
2022-5706K213958
2018-2650K142468
2022-6689K040383
2023-10016Form FDA 483, FEI 1282497
2024-2616K232644
2019-6641K183238
2019-11262K142962
2015-3259K070180
2023-9442P920046
2016-5668K082385
2025-11037K022051, K110306, K190551
2025-11038K022051, K110306, K190551
2025-14165Form FDA 483, FEI 3001236991
2019-2934K180400
2022-2703K150371, K191293
2018-7530K173575
2015-8720K070326, K111314
2026-1761Form FDA 483, FEI 3010770940
2016-5940K151764
2025-11395Form FDA 483, FEI 1811666
2025-2361FEI 2182318
2018-8539K100040
2014-8115P120010, P980022
2015-6579K052776
2016-1262K040021
2021-8620K161667
2019-10636K121579
2020-7144K101519
2017-3043K820339
2015-10197K121609
2025-10939Form FDA 483, FEI 3003007937
2018-7778P870069
2026-5687Form FDA 483, FEI 2513595
2024-2206FEI 1218402
2021-1894K202610
2025-8259K233472
2025-10741K982998
2024-8886P980040
2018-9234K030129
2015-5006K812442
2015-1689K132312
2023-9309Form FDA 483, FEI 3008344687
2025-7196EIR, FEI 3010892830
2019-3480K171534
2020-4778K052025, K861136
2018-6669FEI 4108
2024-6290K870817
2018-8152K140775
2024-5647Form FDA 483, FEI 3005184723
2020-7978P990026
2016-1928K151307
2016-9118K143014
2019-9389K182964
2023-6470K210790
2022-168K001277, K092590, K110277
2019-9720K160903
2026-5852Form FDA 483, FEI 3004142795
2018-6201K171277
2016-6751K131912
2017-6400K010736
2019-9559K140082
2019-4962K011693, K033437, K061317
2021-3467P990018
2020-7797K201301
2021-1460K143372
2015-1639K031012
2021-5137K160764
2024-4468FEI 3003374183
2023-8117FEI 1313525
2015-1696K072134
2020-875FEI 1000448358
2020-8880K193371, P140015, P160017
2016-5013K052596
2015-3624K051085
2020-609K013478, K904739
2024-7802K020823
2018-1158FEI 6664
2023-7319FEI 3002718877
2024-5641Form FDA 483, FEI 3015528919
2023-6745FEI 1000519796
2016-8071K902729
2017-98K103473
2019-1889K141806
2024-4574K903056
2016-7091K041528
2025-9102Form FDA 483, FEI 3009542936
2021-1088K020455
2025-576K242373
2023-11271FEI 2429304
2017-717K051065
2022-6283K173085
2025-8648EIR, FEI 1518939
2024-5531Form FDA 483, FEI 3007532396
2016-1671K052051
2026-9329FEI 2112020
2023-9500K120204
2024-8110K131845, K202182, K223073
2023-10484Form FDA 483, FEI 1000523895
2021-2632K030086
2020-7367K183230
2019-8227K041269, K140580, K940208
2015-9843K100371
2017-10033K031327
2023-6294Form FDA 483, FEI 3001239363
2015-7480K973704
2020-6863K190580
2025-2974Form FDA 483, FEI 3003752255
2016-9213K030404
2020-7141K081050
2024-1216K073570
2019-10280K102520
2016-9209K041775
2024-5657Form FDA 483, FEI 3007712511
2015-7483K130349
2022-6280K111202
2019-6917P150047
2024-6083K034065
2026-5830Form FDA 483, FEI 2523408
2021-8413K190303
2023-9181Form FDA 483, FEI 3016537375
2026-7441Form FDA 483, FEI 3010197287
2021-1063Form FDA 483, FEI 3006546082
2020-1457K172985
2023-3080Form FDA 483, FEI 2026940
2015-9861K833469, K890134
2023-9651Form FDA 483, FEI 1221541
2026-9262Form FDA 483, FEI 1417592
2016-304K970644
2022-2555K193420
2021-57K171594
2020-1736K160707, K161090
2016-363K112370, K120314, K141273
2024-4881FEI 3017199264
2017-7371K923869
2022-6325Form FDA 483, FEI 3008776294
2024-9335Form FDA 483, FEI 3003925108
2020-6234K172832
2025-11454K163001, K211972, K220820
2021-5116K142482
2017-5133K152446
2024-6300K190764
2018-9563K151834
2023-5040Form FDA 483, FEI 3008243322
2019-6913K130873
2023-1024Form FDA 483, FEI 1000160162
2025-704Form FDA 483, FEI 3011218861
2026-4454Form FDA 483, FEI 3013462427
2015-8411K093362
2023-7447K110374
2015-4557K143531
2025-2319Form FDA 483, FEI 3004753838
2018-3305K143570
2024-2146K012241
2014-9802K003033
2018-3093K132817, K141141
2024-4659K183282
2022-2133K010739
2018-4234K170918
2018-1698K172066
2023-10681Form FDA 483, FEI 3007345964
2016-9111K150574
2016-2539K142718
2014-9289K141708
2022-7065K091393
2022-7497Form FDA 483, FEI 3010119152
2023-5539Form FDA 483, FEI 3007645866
2022-8087K191033, K212706, K212767
2018-4996K161700
2025-1299Form FDA 483, FEI 3001576173
2020-8528K003576, K992908
2025-11360Form FDA 483, FEI 3002297831
2021-5031K162895
2025-4438Form FDA 483, FEI 3013394970
2024-298K213398
2024-7437Form FDA 483, FEI 3007208829
2016-8300K873604
2024-237Form FDA 483, FEI 1220423
2019-3492K043363, K123630, K171652
2026-6196EIR, FEI 3000233845
2024-8651K223914
2026-9331FEI 2112020
2026-7447K241066
2019-6041K012351, K020802, K954504
2019-9242K833866
2023-628K133884, K150571, K152926
2023-862K162617
2020-6124FEI 3343
2023-11311Form FDA 483, FEI 3005900820
2019-6620Form FDA 483, FEI 1000119582
2015-9919K002073
2023-3878Form FDA 483, FEI 3000215346
2025-10479Form FDA 483, FEI 3005949964
2018-9593P870024
2025-2494Form FDA 483, FEI 1000125341
2026-1427Form FDA 483, FEI 1000121639
2022-6728K212747
2016-626K110397, K131559, K140257
2018-6685K000855
2024-5132K191378
2021-330K161307
2018-3492K012991
2023-10895EIR, FEI 2124215
2017-323K121297, K161155
2021-7071FEI 1819470
2018-880K171658
2017-892K062298, K080927
2019-8624K173624
2026-9351Form FDA 483, FEI 2112020
2022-8701EIR
2024-1944Form FDA 483, FEI 3004080795
2020-8238K151336, K153399, K171323
2025-4680EIR, FEI 2124215
2020-3104K191658
2026-7389Form FDA 483, FEI 1825560
2014-9668K083415
2022-8612K181116
2025-9201K040163, K090679
2023-7918K220560
2021-5283Form FDA 483, FEI 3009771004
2026-4814Form FDA 483, FEI 3015177815
2019-11148K190180
2019-9106K141177
2024-8671Form FDA 483, FEI 1220246
2015-3745K090318
2025-336K041059
2019-764K150523
2023-8180Form FDA 483, FEI 3010251542
2015-6302K141288
2023-131Form FDA 483, FEI 2242547
2018-8217K162117
2015-5047K960993
2016-1949K140866
2025-734K142282
2018-8080K172166
2015-8060K113201
2022-4433K162627
2017-674K151955
2023-5845K200480
2023-10544K961199
2022-7763Form FDA 483, FEI 3010824482
2016-5803K141163, K153392, K153689
2021-8368K925080
2016-312K070090, K121795
2017-2650K703649
2015-4439K113811
2018-69K161434
2025-13074K051842, K201067
2022-5552Form FDA 483, FEI 3010009693
2026-7440Form FDA 483, FEI 3010131715
2025-2252K936272
2025-4192Form FDA 483, FEI 3007867940
2017-9701K163142
2021-1140K811889, K811923
2024-230Form FDA 483, FEI 3012975098
2019-8543P040008, P060005, P090026
2025-2232Form FDA 483, FEI 3009340644
2021-2772K920773
2021-6235K210759
2026-4936Form FDA 483, FEI 3011508621
2020-4673K163439
2020-8241K061615, K110010, K110715
2015-843K141769
2018-3543K171373
2024-7618Form FDA 483, FEI 2523891
2018-2859K011741, K982412
2015-6216K091935
2022-6792Form FDA 483, FEI 3005949964
2016-2669K022086, K050245, K130794
2026-7846Form FDA 483, FEI 3008817603
2026-9395FEI 1218058
2014-9749K032590
2026-9211FEI 3021060474
2022-1661Form FDA 483, FEI 3001617730
2017-4256K161737
2024-6890Form FDA 483, FEI 3015460945
2023-8863Form FDA 483, FEI 3023167283
2016-5791K152556
2015-10147K021737
2019-706K022574, K043288, K990144
2017-849K152096
2017-9687K072254, K131681, K891008
2017-4185K162309
2026-4914Form FDA 483, FEI 3013696225
2023-5283Form FDA 483, FEI 1000140327
2016-8534K150985
2018-7080K152178
2016-3788K121161, K121803
2025-8831Form FDA 483, FEI 2517077
2015-8037K120333
2022-8914K220997
2019-6990K182940
2025-2081Form FDA 483, FEI 2020372
2016-9696K130560
2023-1162EIR, FEI 1010370
2022-7002Form FDA 483, FEI 3002684533
2015-4835K140284
2023-5193Form FDA 483, FEI 1000526875
2024-6606Form FDA 483, FEI 3026996410
2023-3822Form FDA 483, FEI 1410248
2017-398K834281
2018-1135K172819
2015-1220K954261
2018-7863K172731, K172944, K181368
2021-2853K192268
2024-7050K222547
2025-8119Form FDA 483, FEI 1211177
2015-400K050174, K060846
2015-2641K142697
2017-609K132761
2016-492K141865
2017-880K130210
2022-2408Form FDA 483, FEI 3010412492
2024-10634Form FDA 483, FEI 3002807167
2023-3423K063148
2025-10160FEI 3010162243
2016-10392K151412
2019-4649K182177
2025-790K191272
2023-6809K170974
2015-8770K012852
2023-7577K171652
2015-5938K120315
2019-2101K130442
2025-3692K110962
2023-3718Form FDA 483, FEI 2183449
2017-9548K161768
2017-2198K034057
2023-10069Form FDA 483, FEI 3014498807
2024-7482K123910
2018-6829K100857
2026-1452Form FDA 483, FEI 3004112448
2015-6172Form FDA 483
2024-8678Form FDA 483, FEI 3008194047
2019-9791K062909, K081467, K103087
2024-1139EIR, FEI 2183744
2019-7458K191240
2015-800K001083
2021-170Form FDA 483, FEI 1000477302
2019-9262K894015
2024-415K200483
2022-4196FEI 3004106598
2015-1145K093642
2023-10369Form FDA 483, FEI 1016427
2023-5705FEI 3002808293
2023-6295Form FDA 483, FEI 3010877980
2014-8458K090244
2022-4696FEI 1000175127
2016-5557K961267
2025-9258Form FDA 483, FEI 3001677091
2026-6488FEI 3002807439
2019-7546K163457
2016-8733K143001
2022-4707K180908
2016-9221K050891
2023-11107K150588
2025-2460K870939
2015-1161K124006
2023-2082Form FDA 483, FEI 3010002722
2015-7862K010460
2016-3333K111516, K113830, K133849
2024-951K230997
2015-2106K101791
2021-8612K210561
2019-10868K183296
2022-2137K010156
2021-3415FEI 3003990090
2019-1817K110327
2019-5451K120906
2015-5497K822735, K861316
2025-12398FEI 3003428492
2024-9367Form FDA 483, FEI 3002836339
2016-8079K131248
2025-10377K081233
2016-8201K053358
2024-2962K221943
2022-7855K974303
2025-1459Form FDA 483, FEI 3011504993
2019-5094K060555
2015-7465K073697
2019-1144K170116
2025-8208Form FDA 483, FEI 3003528079
2022-8509Form FDA 483, FEI 3015200795
2018-4801P140003
2026-5411Form FDA 483, FEI 3003338236
2023-251K191352, K200748, K202977
2017-9465P100018
2015-5154K883239
2015-4888K902075
2022-1651Form FDA 483, FEI 3013419467
2017-2554K130581
2023-2268Form FDA 483, FEI 1927197
2021-8682K193135
2020-1738K844920
2017-5367K870374
2025-3273Form FDA 483, FEI 3000241849
2021-677K143203, K150112, K160936
2023-4635K913129
2019-8949K150361
2026-4427Form FDA 483, FEI 2246315
2016-8114K130740
2021-6313K200621
2023-2146Form FDA 483, FEI 1050373
2015-9336K982418
2017-10455K172856
2025-1483K151208
2023-9137Form FDA 483, FEI 3005730406
2015-5202K121765
2025-8890Form FDA 483, FEI 3010599708
2024-9762K990657
2017-340K160614
2018-6523K170551
2014-9341K922052
2016-6414K983517
2024-172Form FDA 483, FEI 1000524572
2016-3951K153449
2025-420Form FDA 483, FEI 1713910
2022-3085K935189
2023-6377K212871
2017-8584K150960
2024-3847Form FDA 483, FEI 3006621944
2016-8596K961433
2019-11964K133811
2020-5736K070779, K150019, K181864
2025-2840Form FDA 483, FEI 3002807308
2017-7417K950822
2025-866K240929, K240993, K241887
2022-7015FEI 1000148471
2019-11174K010031
2025-13047Form FDA 483, FEI 2523676
2016-3851K153486
2020-4718K113693
2022-3179P140003
2023-6406K010670
2025-13101K150907, K192539
2016-3630K142319
2020-7173FEI 6362
2016-7031K142488
2018-798K162905
2025-2651K242913
2026-8352K131098
2017-6581K162205
2016-8115K053112
2021-8520K201772
2024-2005Form FDA 483, FEI 3012728846
2018-7897K173224
2020-4474K903756
2023-6808K200232
2020-5352K130872, K183635
2022-4315K220596
2021-3522K083489, K090325, K100462
2024-55K191747, K203028, K210710
2026-5070K210174, K220938, K250896
2015-3286P960009
2021-7584FEI 3007772056
2025-12005K251229
2020-3907K151117
2023-3659K143386
2018-1351K172935
2025-3082Form FDA 483, FEI 3019856272
2023-8171EIR, FEI 4395
2016-2616K940842
2017-217P060028
2025-12898Form FDA 483, FEI 1000306093
2017-1902K030733
2024-4861Form FDA 483, FEI 3004142400
2023-3976K151987
2017-10690K073482
2019-4792K060232, K060233
2024-6088Form FDA 483, FEI 3003015552
2014-9187K790738
2023-8996K230560, K230930
2026-5148Form FDA 483, FEI 3009542956
2018-7291K001647, K943997
2022-4554K181661
2022-5930K191259
2016-5551K103025
2018-5494K103140, K143233, K170441
2025-4366K142567
2015-7714K024367
2023-6657Form FDA 483, FEI 1929691
2020-4993K152550
2016-4512K123691
2019-610K934738
2021-2539K123910
2018-6873K111992
2016-4642K001536
2024-4416EIR
2026-5388Form FDA 483, FEI 2124215
2025-7910K223669
2018-6608K173929
2026-6490FEI 1825560
2025-10072Form FDA 483, FEI 3002807108
2022-2331K212149
2023-10279EIR, FEI 3005012805
2020-2312K063435, K140775, K170551
2024-7704Form FDA 483, FEI 3005636544

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