Data catalog

FDA FOIA requests

About 15K records

More records

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

2020-6679K170803
2017-2082K151822, K903207, K972074
2018-8069K102330
2023-8745Form FDA 483, FEI 3002199759
2021-8579K191450
2017-4571K161724
2021-2277K161715
2022-7413FEI 3003306248
2014-8613K133272, K910939, K925851
2015-2692K861401
2017-1216P040046
2019-2974K182373
2017-9711K171392
2023-4337P110008
2020-6963Form FDA 483, FEI 2246315
2016-7452K992703
2025-9635K163597
2017-689Form FDA 483, FEI 2981
2025-10335FEI 3021325287
2026-6617FEI 1221435
2018-8857K173626
2025-13044Form FDA 483, FEI 1000524645
2021-2704K082748
2016-8463K120280
2020-223K180818
2021-2887K182964
2023-7778Form FDA 483, FEI 3010128811
2016-4260K002913
2024-3178FEI 3022988037
2018-567K150754
2016-8420K151964
2025-2186Form FDA 483, FEI 3013944123
2019-7720EIR
2020-3828K192305
2019-5435K940909
2016-2222P110014
2015-4594P120032
2025-12078Form FDA 483, FEI 3008414621
2017-4672K003583
2021-6788K203547
2022-2698K061916, K192663, K760736
2016-281K092227
2021-4907K190675
2016-3506K780058
2025-10730K992244
2026-7627K100593
2024-987K231465
2023-5504Form FDA 483, FEI 3007134923
2017-6415K141965
2019-7240K033364, K061301, K113111
2026-1395Form FDA 483, FEI 3017823876
2021-8249K090897, K103233, K121308
2021-4094K152404, K170520, K190024
2023-1832K212156
2018-3709K112409
2023-7818K131036
2019-726P120022
2015-4241K971861
2019-6262K861188
2021-6888K203450
2021-5578K951709
2016-6025K153249
2016-1078P130021
2018-2511K970577
2018-4091K031894, K173865, K983985
2015-4408P040033
2025-3879Form FDA 483, FEI 1000159898
2018-461K021344
2024-1075K160501
2015-1443K110693
2025-3715EIR, FEI 3011050570
2025-831K060937
2023-4699EIR, FEI 3008396914
2016-8924K041295
2017-7147K162748
2025-750K002620, K081960, K082207
2018-7469K172607
2022-6956Form FDA 483, FEI 3003681915
2021-7011K180818
2018-2460K151683
2019-873K182616
2026-9397Form FDA 483, FEI 1218058
2023-4545FEI 1000307073
2025-3714EIR, FEI 3004450998
2022-2122K182766, K190268
2014-8416K012351, K984631
2025-3221Form FDA 483, FEI 3009809074
2026-1034Form FDA 483, FEI 3013034344
2020-5108K170702
2025-3771FEI 3004142400
2014-9015K123546
2020-2476K191406
2017-8227P010032
2020-3102K031463
2022-6957Form FDA 483, FEI 3009998573
2014-9709K111201
2015-3233K983017
2015-3307K023579
2020-6132K180466
2017-7370K855032, K913228, K952434
2026-8147FEI 3004209178
2024-10625EIR, FEI 1000219637
2023-3605FEI 1819470
2016-3309K143155
2018-5469K152115
2019-2832K123813, K141634, K180560
2019-707K910091
2015-3625K040194
2023-8282K183182
2020-3466K083641, K110124, K123672
2026-9302K801550
2019-1899P820056
2019-6629Form FDA 483, FEI 3768
2016-3115K984361
2026-8596Form FDA 483, FEI 3001451489
2019-1082K062181, K133906, K142041
2020-8320Form FDA 483, FEI 3011277306
2018-6375K102597
2015-1694K142940
2026-8617Form FDA 483, FEI 3006052875
2025-10947Form FDA 483, FEI 4053
2023-5041Form FDA 483, FEI 1038823
2025-12899Form FDA 483, FEI 1873886
2019-6230K182008
2022-3431K011132
2020-2202K023548, K162919, K170551
2017-3524K121074
2023-5360K221590, K222476, K951919
2018-7544P030053
2017-6352K990170
2023-6242Form FDA 483, FEI 1819470
2021-5353P140033
2021-2639K002617, K023305, K972723
2016-9283K160931
2017-5588K152712
2017-2346K151377
2015-1219K122474
2016-6932K013362
2016-3322K150883
2018-649K171120
2020-2420K052523, K070743, K151651
2017-10456K060743
2024-6452Form FDA 483, FEI 3003059934
2026-6207Form FDA 483, FEI 3029926469
2019-5666K183343
2023-9698K231335
2025-9255Form FDA 483, FEI 3013020160
2015-1606K101882
2017-5684K134032
2017-1497K072982
2024-9127K240616
2023-8858Form FDA 483, FEI 3006371704
2024-4747K032716
2026-6059Form FDA 483, FEI 3007922509
2016-8672K130921
2016-3210K153090
2016-10105K142059, K152276, K162571
2018-5308K052567
2017-1073K902999
2025-827Form FDA 483, FEI 3015177815
2021-305Form FDA 483, FEI 3006985147
2018-6667K152341
2023-6471K200171
2020-7530Form FDA 483, FEI 1220246
2023-4425K112595
2015-5959K964518
2023-6957K202280, K212578
2018-4454K173489
2025-299FEI 3007353760
2017-5618P130023
2015-4882K002136
2018-2719K163283
2017-8456K122501
2023-6405K203429, K223046
2017-9990K160364
2015-662K080816, K081162
2020-7948Form FDA 483, FEI 2182501
2025-12825Form FDA 483, FEI 3017140511
2023-1198FEI 3002807944
2022-7765Form FDA 483, FEI 3011583553
2020-7345EIR, FEI 3002807041
2019-5072K183645
2015-7052K141081
2022-5379K122288, K153473, K171410
2024-1568Form FDA 483, FEI 3013722099
2016-7544K031562
2022-6528Form FDA 483, FEI 3004453700
2024-8150Form FDA 483, FEI 2510592
2023-3090FEI 3003166194
2016-1241K082982, K100528, K102525
2017-2306K001122, K033337, K962530
2022-8747EIR, FEI 3010800486
2014-9067K061381
2018-318K152754
2025-9467Form FDA 483, FEI 1718912
2026-5399K223085
2018-5592K962985
2025-10382K243678, K243782
2018-6960K181749
2022-3924FEI 3010667733
2022-3934K140054
2015-5240H990008
2014-8284P110006, P130017
2016-713K050275
2026-1297K250031
2022-2696K043143, K071973, K182422
2025-12095Form FDA 483, FEI 3025107383
2021-3939K874428, K901107, K904931
2023-9324Form FDA 483, FEI 3011395139
2023-5529K923996
2017-1578K071266
2026-8124Form FDA 483, FEI 3027386225
2022-8506K151345
2020-553P050018
2015-171K083704
2015-7533K111450
2024-9233Form FDA 483, FEI 2410808
2019-4389K180020
2018-5992K170897
2025-12863Form FDA 483, FEI 3005334138
2016-6940K131198
2025-7382K221052
2022-5318K210536
2019-6232K092032
2015-1416K140841
2023-1865K013527, K042899
2017-5575P140020
2026-8093Form FDA 483, FEI 3010892830
2017-4735K120103
2017-3017K012105
2022-684FEI 3011391433
2024-7082K101154, K150930
2025-13701FEI 3016678465
2023-10568Form FDA 483, FEI 3013820501
2016-7231K100120
2024-5398Form FDA 483, FEI 3002807005
2015-257K122325, K913023, K925545
2016-4129K153361
2026-1851P240020
2022-4283Form FDA 483, FEI 3007772056
2016-2295K993592
2024-1949Form FDA 483, FEI 3005290929
2020-3513K101356, K132987, K152304
2025-1913Form FDA 483, FEI 3010342616
2023-7779K223144
2021-4494K143114
2019-11917K183599
2025-9408Form FDA 483, FEI 3004305946
2025-10189FEI 3020652309
2025-11566Form FDA 483, FEI 3004161147
2017-6877K160881
2023-50K213562
2025-10777Form FDA 483, FEI 3005670221
2018-6370K173200
2026-2005K020798
2019-919K173164
2023-7522Form FDA 483, FEI 3012770122
2016-872P990074
2023-10256K163714
2024-9655Form FDA 483, FEI 3003399824
2017-3940K160915, K163015
2023-8880K051385
2024-4809Form FDA 483, FEI 3019843904
2022-7611Form FDA 483, FEI 1000513101
2025-8787Form FDA 483, FEI 3017503380
2015-2950K081042
2017-2411K100744
2017-8934K001781
2025-13512K232586, K250335
2026-6261Form FDA 483, FEI 3033428382
2018-878K153638
2019-4651FEI 2017865
2017-10115K963183
2024-7400Form FDA 483, FEI 3013435121
2020-6026K102692
2016-6413K984413
2017-2363K133281
2014-9747K033836
2023-6449Form FDA 483, FEI 1919278
2020-8820Form FDA 483, FEI 1000517638
2016-6640K123571
2023-132Form FDA 483, FEI 2024800
2024-1418K201082, K203088, K220107
2016-5288K900832, K905781, K932755
2017-4865K981262
2022-3593P140003
2023-6879K110306
2018-3541K161431
2025-10176FEI 3030159375
2023-6799FEI 3004170064
2017-7838K052698
2025-7857Form FDA 483, FEI 3008819649
2014-9390K072619
2022-1789FEI 3007193505
2020-4202K010052, K061993, K100040
2018-2105K961735
2015-2538K121396
2022-6384K070328, K082660, K083526
2016-4674K000126
2026-9507K233630
2026-4467Form FDA 483, FEI 1416980
2015-1222K131153
2018-6604P950022
2018-2310K112314
2023-2277Form FDA 483, FEI 1000305932
2022-3380K220158
2020-7282K201098
2026-1247Form FDA 483, FEI 3009340644
2022-377K182700
2018-2589K160176
2025-892EIR, FEI 1819470
2026-5198Form FDA 483, FEI 3030898585
2015-8604K132749
2026-6591K171637
2019-8415K171189
2016-8140K031342
2016-3959K101769
2023-9378Form FDA 483, FEI 1937100
2026-1859Form FDA 483, FEI 3003169402
2019-4505K162466
2025-8914Form FDA 483, FEI 3004161147
2014-9526K972706
2023-7796FEI 3004106598
2018-8692K081740
2024-5656Form FDA 483, FEI 3014328942
2020-8070P070026
2018-5612K950709
2018-1575K173450
2026-9475Form FDA 483, FEI 3018326554
2023-5730Form FDA 483, FEI 3012624817
2019-9832K091930, K113398, K123632
2022-8904K161382, K200232, K200621
2022-1086K111210, K122361, K141758
2015-443K030802
2025-13028K202977, P230003
2016-77K071160
2019-7245H010002, H020008
2025-3625K964436
2015-9888K081981
2017-1336K102341
2024-1404K953257
2022-2474FEI 3009534409
2015-106K090283
2019-8229K063692, K130852, K133276
2016-4646K053514
2022-6762K202079
2021-2138K153049
2019-8231K051093, K081996, K102519
2015-403K122886
2016-6771K082227
2018-2032K952882, K964554, K973873
2023-10313K103433
2017-6358K072397, K113282
2023-325Form FDA 483, FEI 1221053
2024-1918Form FDA 483, FEI 3008395118
2024-6295K130304, K904834
2015-8386K134031
2019-114K100510
2021-7572K181642
2024-6942K122894, K163741, K192732
2023-10606K961366
2014-8280K120233, K122137
2026-1827K050162, K230320, K925640
2019-10042K100341, K110582, K130163
2025-14141Form FDA 483, FEI 3005310494
2021-952K171255
2026-6050Form FDA 483, FEI 2280596
2026-8822FEI 3003418325
2024-10089Form FDA 483
2026-9363Form FDA 483, FEI 3003793491
2021-7711FEI 3017845288
2023-8754Form FDA 483, FEI 3001451489
2014-9981K071876, K111266, K112794
2015-7755K143236
2019-10903FEI 3013756811
2019-10084K140306
2023-6031K984358
2020-8684P160047
2025-559Form FDA 483, FEI 3001451826
2025-9750K152947
2017-10159K014099, K140068, K151545
2017-7714K091299
2019-5541K150617
2023-7417Form FDA 483, FEI 3006404071
2017-4400K870188
2018-7065K173004
2019-7194FEI 1718912
2020-5064K970102
2021-1861K203086
2015-9837K090422
2019-5012K032426
2023-10155Form FDA 483, FEI 1000582923
2018-7281K050094
2022-6058K073482
2018-5169K171958
2019-832K163689, K173784, K173785
2015-4825K093138
2022-7381Form FDA 483, FEI 3926
2019-2656Form FDA 483, FEI 4247
2015-1014K071733
2018-9577P820063
2015-9326K142732
2020-531P160008, P160012, P160015
2024-1006Form FDA 483, FEI 3005874553
2026-6226K790608
2022-4030K162128
2023-8955K221294
2015-8141K090189
2018-3340K040780
2025-1102K862317
2016-1895K925794
2026-1860Form FDA 483, FEI 3002904345
2019-6215K091659
2026-6793Form FDA 483, FEI 3015414274
2025-12194Form FDA 483, FEI 3002807295
2018-9544P820063
2015-220K083344
2025-2642K163510, K202406, K220068
2015-10161K150499
2021-3331K210193
2023-10646Form FDA 483, FEI 1717046
2021-2180K202554
2017-7527K110569
2022-7820Form FDA 483, FEI 3011680766
2023-2272Form FDA 483, FEI 3012295910
2026-6406K163217
2023-8580Form FDA 483, FEI 1416980
2022-8220K212217
2020-8008K160331
2015-6298K141371
2024-8136Form FDA 483, FEI 3007666314
2018-4679K081635
2023-3632K191332
2023-190Form FDA 483, FEI 3008002452
2024-5419K061711, K122885, K140023
2025-3865Form FDA 483, FEI 3002480795
2018-4518K170505
2025-1418Form FDA 483, FEI 1218882
2015-2434K031649
2019-1845K083020
2020-509K072740
2019-6920P090016
2026-8383EIR, FEI 3017636737
2023-10668K220830
2017-3341K020776, K021383, K974761
2015-8158K021094
2018-7925K060764, K083208, K141434
2015-6975K002488
2017-3327K043341
2019-7770P160048
2024-1919EIR, FEI 3005596071
2024-7643Form FDA 483, FEI 1810189
2016-740K143153
2022-2334Form FDA 483, FEI 3003124453
2024-7857Form FDA 483, FEI 3012883202
2017-1645K160811
2021-7791K000180
2021-1067Form FDA 483, FEI 3002808268
2019-9319K141059
2015-4409P050016
2019-11699K081532
2015-7229K093665, K971125
2015-3661K063304
2025-9339K151208
2024-4349K051647
2015-7650K142794
2017-7510K012878, K974620
2015-2151K970748
2016-4891K123637
2020-3226K163265
2025-13204K223266
2023-8461Form FDA 483, FEI 3010477
2023-10241Form FDA 483, FEI 3002806497
2019-4442K173444
2020-105K161463
2021-4430K130069
2021-3283K200500
2022-7752Form FDA 483, FEI 3005951712
2025-3402Form FDA 483, FEI 3009638066
2020-2895K191391
2018-334K120944, K132360, K163620
2020-5187K002717, K033523, K082438
2023-10057Form FDA 483, FEI 3009710316
2022-2688K191031
2018-8636K171696
2017-9166K032301
2016-1960K895640
2023-4317P110042
2017-5156K160845
2026-1869Form FDA 483, FEI 3010785603
2022-2651K010849, K030382, K151638
2024-664K132671
2022-4323K212180
2022-2135K080427
2021-7206K180474
2024-4000K081672, K102130
2025-10535K832906, K862412, K864552
2023-9482K161431, K173248, K231620
2014-8224K120092
2021-4491K103316
2016-7865K020041
2022-5072K143577
2017-1232K162895
2017-3036K112468
2023-4533K981797
2018-6872K121171
2022-8304Form FDA 483, FEI 1000111286
2022-2690K112822
2018-6388K090932
2016-1065P140031
2023-5471K042415
2024-8590K160127
2019-95K123265
2018-3509K101298
2024-9057K183067
2023-6580FEI 5672
2016-7548K111572
2019-1110K173582
2025-7210K903136
2021-612K001781
2024-7616Form FDA 483, FEI 3009205152
2023-5178K081509, K182036
2023-9492Form FDA 483, FEI 3002513708
2017-6643K093447
2025-2530FEI 3194
2019-6814K182075
2020-7870K171992
2014-9239K123402
2024-2274K190043
2015-2581P000025
2018-2716K932385, K935665
2026-5089H020007, P960009
2022-2564K212725
2025-3824FEI 3008959459
2018-3107K031838
2017-225P030053
2018-7651K180698
2016-8597P910023
2023-2823Form FDA 483, FEI 3003169402
2019-8597K052808, K062189, K090300
2023-4333K201808
2015-6388K023566
2017-18K981091
2026-6808Form FDA 483, FEI 3008413470
2022-5085Form FDA 483, FEI 3007772056
2016-1557K142551
2025-8590FEI 2013736
2025-13604K201298
2014-8198K133223
2024-9548K011666
2017-147K003126
2022-6679K201066
2025-7675Form FDA 483, FEI 3004380247
2026-8020Form FDA 483, FEI 2013342
2021-1036K110456
2017-7363K163529
2025-200K191057
2016-958K062716
2017-6875K102461, K140926, K151793
2023-10729K161354
2024-8338K130896, K981624
2019-4784K033052, K040194, K051085
2019-6151K052303, K120450, K152040
2025-11648K212615, K242429
2026-5468Form FDA 483, FEI 1032500
2023-4807K221070
2020-6800P980052
2020-8007K152286
2025-4396K003458, K021859, K030474
2023-8987Form FDA 483, FEI 3005857264
2025-12894K242907
2024-9363K130113, K200865, K992140
2018-4357K932364, K932369
2021-569K002830, K121688, K140780
2023-3325Form FDA 483, FEI 3002797442
2025-11043Form FDA 483, FEI 3010728615
2016-6543K160252
2015-7846K083620
2017-6125K150407
2022-2958K150877, K181751, K192109
2024-2438K180513, K193547
2018-8117K170159
2015-61K040973
2017-10703K121484
2019-8218K143267
2018-1500K002892
2026-6393Form FDA 483, FEI 3012148004
2018-8568K133251
2014-8099K133809
2015-9691K132343
2023-7813Form FDA 483, FEI 2126519
2022-8723K121057, K121735, K152733
2015-4813K100117
2026-6260Form FDA 483, FEI 3025308469
2024-10106K182732
2019-7207K190819
2019-10921K142061, K163676
2016-4120K091338
2015-771K021494
2016-2334K100874, K112626
2026-8129Form FDA 483, FEI 3001451489
2019-5032K883609
2019-2228K151285
2018-1511K163485
2023-510Form FDA 483, FEI 3004183512
2019-8989K161768
2018-2784K102973
2021-7667P150001, P160017
2026-6508K250690
2024-790Form FDA 483, FEI 1419181
2021-481K191676
2024-3636FEI 1419377
2020-4663K192606
2018-9881K151336
2026-5791Form FDA 483, FEI 3003306559
2026-9342FEI 3003793491
2014-9878K951721
2025-7740Form FDA 483, FEI 3017298490
2025-12000Form FDA 483, FEI 1413399
2015-4686K073262
2019-10318K833430
2024-4395FEI 3014526664
2024-691Form FDA 483, FEI 3002808337
2018-8035K031078
2025-1082K940606
2023-7976K172604
2020-5581K161304, K161467
2024-4047K212696
2021-7858Form FDA 483, FEI 4323
2023-10955K875142, K875145
2014-9915K140933
2022-5483K172246
2024-6269Form FDA 483, FEI 3003374183
2019-4783K000068, K103072, K111479
2018-1769K112341, K163188, K170982
2016-3977K013056
2021-960K042936, K110771
2024-9903Form FDA 483, FEI 3010329663
2025-4290K093310
2014-8803K932301
2022-448K190593
2022-5953K121700, K122528, K132028
2021-4575K101309
2025-14390Form FDA 483, FEI 3006784948
2016-10619K121590
2014-9018K090850
2015-1434K121609
2023-7895K050235, K091539
2017-4139K163523
2022-3077Form FDA 483, FEI 3008146975
2026-9506K233886
2015-3942K102452
2015-8697K150481
2024-5044K150669
2026-7816Form FDA 483, FEI 3023251262
2023-640K093395
2023-3759Form FDA 483, FEI 3007981285
2018-6277P080032, P180002
2020-5740K160761
2023-2064K222476
2015-3389K133534
2017-6417K140151
2020-6937K171435
2015-560K142168
2024-4863K771228, K791774, K844077
2022-8492Form FDA 483, FEI 3011682748
2016-6638K092623
2015-300K001962, K002099
2021-3245K210444
2025-11084Form FDA 483, FEI 3019216
2018-5459K173372
2026-5354Form FDA 483, FEI 3011508621
2017-3145K102966, K132567
2019-7487K131252, K133521, K141480
2015-7915K130921, K140933, K142672
2017-9402K172414
2015-9473K142245
2023-8573K192525
2020-7531Form FDA 483, FEI 1000120578
2025-3179Form FDA 483, FEI 3003775072
2016-2895K132829, K150267
2025-12179Form FDA 483, FEI 3005977121
2023-3633K093243
2025-13183Form FDA 483, FEI 3017140511
2025-8906Form FDA 483, FEI 1213643
2022-4292K183635
2019-6919P110027
2020-802K951904
2023-4426K153302
2026-5140Form FDA 483, FEI 3004161528
2019-103K152956
2018-9173K180197
2016-10550K153661
2019-2778K161636
2025-7930Form FDA 483, FEI 2244725
2014-9007K101910
2019-1644K111080
2018-4952K173214
2023-8365Form FDA 483, FEI 3012265577
2022-7808FEI 3002808845
2017-209P040046
2020-5082K152567, K181264
2017-2109K140589
2015-900K063753, K081729
2023-2418K220407
2023-3657K120897
2021-5038K203717
2020-6407K193654
2020-7688K183089
2014-9344K050337
2025-8746K223620
2023-4564K182078
2019-11701K190898
2026-9064Form FDA 483, FEI 3011913386
2025-11574P840001
2018-3406K931393
2025-12542Form FDA 483, FEI 3001239363
2014-8875K070157
2022-5344K212947
2016-6305K143120
2017-3647K162508
2019-8215K001962, K002099, K042455
2019-6219K081777
2020-3269K183432
2023-7649Form FDA 483, FEI 3010437008
2017-9896K093204, K100213, K101267
2020-6472K950621
2015-10163K151632
2024-7694Form FDA 483, FEI 3014407293
2026-7132Form FDA 483, FEI 3005763425
2019-2239K181740
2023-10206Form FDA 483, FEI 3011068448
2023-11197Form FDA 483, FEI 3010413216
2017-4235K003759
2024-5174Form FDA 483, FEI 3008514029
2021-1094P160048
2016-4214K922441
2017-4233K142024
2015-1311K961837
2023-7530Form FDA 483, FEI 3003572099
2023-1992FEI 3002807944
2014-8715K133753
2026-5853Form FDA 483, FEI 3020856782
2019-9192K151244
2022-6881Form FDA 483, FEI 3017936974
2018-5567K081565
2026-6314K252544
2022-8548Form FDA 483, FEI 3010409478
2016-7070K771985
2022-4600Form FDA 483, FEI 1000136478
2020-7947Form FDA 483, FEI 3007738819
2015-8318K132749
2023-6284K212156
2015-3818K123546
2023-3604FEI 1819470
2020-166P990081
2026-7133Form FDA 483, FEI 3003514332
2022-4008K072020
2024-4837Form FDA 483, FEI 3009668937
2021-6729K182181
2026-9120Form FDA 483, FEI 1220908
2024-648Form FDA 483, FEI 3011422544
2018-1467K942044, K973500, K992833
2025-7993Form FDA 483, FEI 1000135935
2016-5695K041686
2015-2707K770002
2025-296K883917
2014-8204K900003
2022-7220K010675, K823737
2025-13090Form FDA 483, FEI 3006349554
2026-9510K232919
2024-339Form FDA 483, FEI 3015422783
2016-8970K153049
2023-3813FEI 1313525
2021-3749K153049, K173727, K191828
2026-6458Form FDA 483, FEI 1000120897
2015-3466K133948
2016-8939K053501
2023-4329Form FDA 483, FEI 2245437
2023-3259Form FDA 483, FEI 3015614180
2017-9551K101995, K152258
2024-4183Form FDA 483, FEI 3004507660
2020-1646K171897
2017-3477P120005
2021-5223K072290
2021-3831Form FDA 483, FEI 3009595577
2017-1097K020227, K030382
2022-7553K192059
2025-1089K894269
2024-9630K930496
2022-3055Form FDA 483, FEI 3009492128
2014-9734K133226
2025-9503Form FDA 483, FEI 3002807040
2019-11160K122801, K161642
2025-10943Form FDA 483, FEI 3013960655
2016-808K880232
2017-9218K113572
2021-6856K083300
2016-9K990461
2016-4715K133022
2024-3502Form FDA 483, FEI 3004170064
2018-5577K170507
2020-2517K161484
2015-6328K100597
2025-11980K251971
2026-9344FEI 2112020
2015-5170K141119
2015-7115K760936
2015-8127K102761
2019-8271K120816, K121891, K833549
2017-10399K172111
2019-11629K190176
2017-3550K061090
2022-6937K200776
2016-6328K090585
2020-7512K954237, K962430, K962431
2022-5407K173931
2016-8161K072601
2023-827Form FDA 483, FEI 3005841768
2019-7879K150535
2022-1084K935842
2025-13201K223469
2016-9999K092625
2025-833K033357
2014-9451K062416
2019-7710K032644, K042816, K072234
2015-9619K031328
2021-7879K160016
2025-2184Form FDA 483, FEI 3010676138
2015-2857K012472, K042506, K110044
2018-9607K011488
2015-7867P990009
2016-10073K063229, K083400
2022-5479K061313
2021-7635K191718, K192268, K200547
2022-466FEI 3005892511
2021-4760FEI 7300
2016-4197K864218
2015-6583K100556
2026-9054Form FDA 483, FEI 3000717944
2021-6979K161384
2019-6750K012715, K032821, K040324
2018-412K001852
2016-5275K112924
2023-8777Form FDA 483, FEI 3001451489
2016-1961K143615
2024-6381K904210
2023-11439Form FDA 483, FEI 3002477077
2017-1437K161090
2026-7435K222010
2016-6955K102511
2026-4991Form FDA 483, FEI 1513988
2024-7778Form FDA 483, FEI 3013400718
2016-4618K974186
2017-6458K081625, K081626, K082481
2018-709K152319
2021-7082EIR, FEI 3006813973
2021-4926K133036
2016-8721K132297
2018-42K880038
2026-6460Form FDA 483, FEI 3015431638
2025-12625Form FDA 483, FEI 3010167805
2023-5113Form FDA 483, FEI 3008513398
2017-6959K081767, K110605
2021-5699K063835
2018-5673P850007
2024-9776FEI 1946929
2024-9418K032041
2026-8130Form FDA 483, FEI 3011547157
2022-2711FEI 2183425
2023-5443Form FDA 483, FEI 2523891
2022-4316K220596
2025-8806K864323
2016-7450K130223
2020-1983K001647, K050135, K141718
2017-2920K150869
2024-3156P160026
2025-12216Form FDA 483, FEI 1000124215
2016-1776K000795
2024-8485K905083, K926433
2019-3600K113621, K151199
2021-2300Form FDA 483, FEI 3010667733
2024-3499Form FDA 483, FEI 3004185580
2025-1344K101847, K992069
2015-3075K053625, K120894, K132520
2024-62Form FDA 483, FEI 3001675293
2021-5685K200803
2018-5674Form FDA 483
2025-2228Form FDA 483, FEI 1819470
2018-4687K173405
2017-7595K072757
2021-2769K871881
2016-5508K082315
2017-8195K161183
2021-8637K202345
2018-8131K171429
2016-2173K043260
2016-8528K160537
2022-45K152286, K182556
2022-4159K211222
2022-7534K110457
2021-5828Form FDA 483, FEI 2025816
2018-6403K151127
2025-10019K210069
2018-1339K162323
2020-7654K090083, K111105, K132325
2019-7849K183344
2025-8757Form FDA 483, FEI 3001642379
2022-7010Form FDA 483, FEI 3015775837
2022-5015K212981
2021-8508K192154, K192880, K193654
2021-4193Form FDA 483, FEI 1000477999
2019-11573P040024
2018-6687K072240
2016-9782K121370, K910875, K970788
2023-9706Form FDA 483, FEI 1819470
2023-6904Form FDA 483, FEI 3021169199
2016-8448K061903
2015-9007K150639
2017-2866K161457
2021-1911K022124
2025-1798K090414
2022-177FEI 1050373
2024-10062Form FDA 483, FEI 3008384335
2016-815K021792
2022-6198P120006
2022-3036K080355
2019-9560K152115
2017-3639P120005
2018-1372K150880
2025-4194Form FDA 483, FEI 3012075008
2020-6649K182456
2025-14292Form FDA 483, FEI 3002864192
2018-9116K133226
2024-5658Form FDA 483, FEI 1000137876
2017-382K023116
2021-2636K203550
2023-982Form FDA 483, FEI 3016743107
2016-7764K130010, K141142, K141771
2022-8554Form FDA 483, FEI 3007856226
2021-4403K092639
2017-3118K131601
2014-8541K103758
2014-8556K051980
2025-1777Form FDA 483, FEI 1319211
2016-3923K050418
2021-8031K210936
2016-8591K950889
2023-9438Form FDA 483, FEI 3002836339
2014-9259K090696
2024-10941Form FDA 483, FEI 3003272809
2023-7513Form FDA 483, FEI 3014833750
2017-7190K163225
2017-485K070065, K071902, K073703
2022-1659Form FDA 483, FEI 3001237338
2016-6106K101104
2018-636K021442, K021446, K091272
2020-6186K182372
2022-4298K960047, K960049, K965030
2026-5336Form FDA 483, FEI 1222117
2024-8124K231355
2021-1479P190032
2015-1827K993678
2018-3198K140407
2021-4876K173681, K173860, K173974
2023-4075FEI 3003701733
2016-4620K113770
2022-2761Form FDA 483, FEI 3003197096
2014-10040K040415, K942583, K971048
2015-4058K082188, K103595, K133921
2024-5899K240297
2016-9285K160026
2015-3567K142988
2016-4846K152569
2016-566K093717, K142603
2024-2029Form FDA 483, FEI 1039131
2019-111K080917
2024-6113K113106, K140158, K151580
2022-5145K131036
2023-5490K033548
2018-9082K132038
2024-649Form FDA 483, FEI 3006191977
2023-10915K222658
2025-1785K925378
2021-3182K132623, K151244, K162567
2023-11391Form FDA 483, FEI 1000135935
2022-6811Form FDA 483, FEI 3007134734
2018-5872K131103, K131553, K984233
2024-1552K223213
2015-2787FEI 3374
2026-6136Form FDA 483, FEI 1250045
2016-7097K152568
2021-8650K170435
2015-1192K040858, K080228
2017-1643K160434
2023-2801FEI 3010511300
2020-5956K030226, K140596, K141109
2024-7920Form FDA 483, FEI 1000117611
2022-3611K130255
2016-5660K811036

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