Data catalog

FDA FOIA requests

About 15K records

More records

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

2020-786K030226
2016-4198K123215
2016-5991K120486
2023-3664K220677
2025-1033K242277
2020-6467K103410
2026-1033Form FDA 483, FEI 3012121192
2017-4943K013481, K122454, K150766
2026-1454Form FDA 483, FEI 3007697975
2021-219K883780
2017-5690K120023
2020-1599FEI 3007607709
2023-2682K212382
2026-9157FEI 1220908
2024-10333K182972
2025-3876Form FDA 483, FEI 3014171792
2017-5937K791013
2017-2679K040066
2019-8632K050132
2015-2297K883346
2018-3694K062828, K072522
2017-9042K090996
2025-3862Form FDA 483, FEI 3006892202
2025-3857Form FDA 483, FEI 3010052743
2023-11125Form FDA 483, FEI 3004161147
2021-2856FEI 7300
2026-8229Form FDA 483, FEI 3017812890
2015-9942K061866, K143197
2023-5819K152189, K181472
2025-7107K082196
2023-2813Form FDA 483, FEI 3003007907
2020-4218EIR, FEI 3004444888
2020-4301K071937, K191274
2020-4536K190555
2025-3718Form FDA 483, FEI 3027347389
2018-2695K003301, K033840, K973050
2016-2693K082079
2018-6665K172431
2021-3279K202037
2015-8326K032376
2017-3255K080161, K130826
2022-2039K063091
2017-5548K160210
2018-6221K173595
2024-107K132109
2025-1336Form FDA 483, FEI 3006851654
2015-7060K061050, K100280, K963872
2024-4478K170366
2023-6738K173087
2018-5222K052925
2015-6661K082626
2016-7522K101867
2025-10932K792195, K820522, K832382
2024-8792Form FDA 483, FEI 2221941
2018-1173K062339
2015-6012K033880
2018-2204K133212
2026-6590K221824
2023-1448Form FDA 483, FEI 1525897
2022-5960K200865
2021-1493K020227
2022-8537FEI 3001421318
2017-4005K905119, K923442, K923739
2026-4457Form FDA 483, FEI 3001413302
2019-8811FEI 5714
2015-2169K941407
2026-2026Form FDA 483, FEI 3007965489
2020-2812FEI 1045125
2020-8212K121171, K132276, K140273
2024-1366K222327
2023-7202FEI 3014469173
2020-1139K153094
2016-3303K151532
2015-7301K090474, K091411, K093998
2022-6951Form FDA 483, FEI 3016721526
2021-6802FEI 1045254
2017-7894K162613
2023-8227Form FDA 483, FEI 2245590
2016-2680K961939
2023-8857Form FDA 483, FEI 3004932373
2020-4975K050104
2016-8306K103787
2026-5777K243052
2025-300FEI 3016856381
2022-2149K141389, K153193, K170982
2016-4744FEI 7282
2016-3933K130265
2022-7459K905069
2023-5858Form FDA 483, FEI 3003500271
2018-9960K991637
2024-5695Form FDA 483, FEI 3007137928
2026-9334FEI 3003793491
2019-3736K153427
2024-5511K953681
2019-7693P050018
2016-1950K943305, K960673
2017-3197K013648, K023811, K031041
2026-4453Form FDA 483, FEI 2182762
2015-5783FEI 4580
2020-2445K193229
2025-2421K012009
2026-5571EIR, FEI 2246315
2020-7139K173796
2025-7227Form FDA 483, FEI 3006791967
2017-5523K071390
2026-5893K253638
2022-3125Form FDA 483, FEI 3004161147
2023-2601FEI 1219205
2015-5741K021230, K081473, K111601
2023-10483Form FDA 483, FEI 1000120314
2025-1804Form FDA 483, FEI 1318843
2024-9626Form FDA 483, FEI 3006265099
2017-3309K042992
2021-7624K062482
2018-5475K181051
2022-3156Form FDA 483, FEI 2244019
2025-7978Form FDA 483, FEI 3012448339
2024-10334K140944
2019-1382K913490, K923419, K960656
2018-2118K171158
2023-9310Form FDA 483, FEI 3006371704
2017-7149K162572
2025-11830Form FDA 483, FEI 3013276158
2023-7365K852509, K852510, K941126
2018-2262K060888
2024-7684Form FDA 483, FEI 3003079019
2022-1K190764
2018-9715K082687
2022-2275FEI 3010685285
2025-7275Form FDA 483, FEI 3002807108
2023-8189FEI 2938889
2020-6350K031206, K041485, K071673
2025-10560K251101
2015-6141K032350
2020-7780K163058, K163537
2016-2992K151622
2016-8589K083574
2020-2499K830199
2018-757K152258
2025-11060Form FDA 483, FEI 3014653196
2019-3663K163623
2023-3526Form FDA 483, FEI 3015527848
2019-9565K160942
2018-6548K180111
2015-1447K971918
2018-408K022950
2024-8283K081672, K090855, K102130
2016-529K152041
2024-1199Form FDA 483, FEI 1421101
2019-1403K171610
2023-329Form FDA 483, FEI 2000020733
2024-8364K233798
2020-5872K180904
2015-9318K143577
2022-1164K190719
2026-5815FEI 1825560
2017-8494P040033
2016-966K033448
2024-9674Form FDA 483, FEI 3016721526
2023-1027Form FDA 483, FEI 3008778066
2018-9189K132940
2026-9039Form FDA 483, FEI 3000205837
2015-3627K143280
2022-8110K183579
2019-10220K140954
2026-9198FEI 6034
2019-8599K122528, K142491, K142895
2019-8639K002964
2025-89Form FDA 483, FEI 3007130914
2026-5604K080210, K130324
2020-7371K193228
2019-3191K161554
2023-9551Form FDA 483, FEI 3003015552
2022-7037Form FDA 483, FEI 3013095415
2025-8894Form FDA 483, FEI 2026940
2020-4472K894828
2023-7786K181771
2023-3272Form FDA 483, FEI 3006059917
2022-4193FEI 3002773840
2023-188Form FDA 483, FEI 3003897287
2017-6172K090474, K132104, K150372
2020-752K193202
2026-9347FEI 3008642652
2018-2875K171858
2022-7759Form FDA 483, FEI 3005299806
2014-7998K132671
2023-3068Form FDA 483, FEI 3015200642
2022-6625K212896
2023-10212Form FDA 483, FEI 3007728094
2023-3652K192415, K200948
2025-8007Form FDA 483, FEI 3008500974
2016-2065K955300
2023-10651Form FDA 483, FEI 3009751352
2015-2540K940973
2016-10141K051992
2020-4992K093065
2023-9984Form FDA 483, FEI 3010176616
2015-9917K983454
2024-8167K003458, K030691, K141194
2020-3841K092221
2018-7661K170102
2025-10653K031099
2022-6267FEI 3000215614
2022-2114K193054, K201005
2014-8223K091071
2021-2065K173681, K191716
2018-1335K171556, K172268
2015-1886K141318
2025-7176Form FDA 483, FEI 1000639866
2022-7888Form FDA 483, FEI 3004099493
2023-3650K163232
2016-6902K161210
2024-528Form FDA 483, FEI 3003517954
2024-10476K171699, K171771, K201867
2025-11473EIR, FEI 1810189
2019-4525K163001
2026-8360Form FDA 483, FEI 3002807145
2019-3798K801757, K801758
2015-2642K130545
2026-9399Form FDA 483, FEI 1218058
2023-10731Form FDA 483, FEI 1000132079
2016-2690K113032
2023-5821Form FDA 483, FEI 1819470
2026-5475Form FDA 483, FEI 1520020
2025-11465Form FDA 483, FEI 3015217553
2020-7982K090489
2025-10336FEI 3005857264
2016-7525K142349
2025-7347K232080
2025-10389K200351, K200353, K210284
2019-9110K070598, K143155
2023-2760Form FDA 483, FEI 3002606748
2016-2203K111362, K121862, K122872
2024-2280K003833, K071397, K942246
2020-4979K030684, K081740, K103730
2018-1895K170784
2020-2877K180454
2025-4483Form FDA 483, FEI 3002889431
2024-6621Form FDA 483, FEI 1000120776
2025-829K091195
2018-851P100009
2021-6637FEI 3926
2026-5008Form FDA 483, FEI 3001698565
2023-7539Form FDA 483, FEI 3015775837
2019-3733K171544
2023-5223FEI 3002907620
2023-10675Form FDA 483, FEI 3004361445
2022-6894Form FDA 483, FEI 3014389576
2021-3040K182519
2022-8303K150914
2024-9301Form FDA 483, FEI 3014407293
2014-8460K132028, K134032
2015-165K141450
2021-7053Form FDA 483, FEI 3010470577
2025-7702Form FDA 483, FEI 3003258310
2024-338Form FDA 483, FEI 3011656326
2019-6321K182564
2018-1787K171269
2020-6466K173926
2016-4519K051188
2014-8621K101477
2020-7073Form FDA 483, FEI 6750
2024-7394K231578
2017-10575K152086
2018-9578P820056
2023-6058Form FDA 483, FEI 3006897899
2019-10057K152938
2021-5136K142491
2025-3866Form FDA 483, FEI 3010023733
2021-3450K103758
2025-10739K843608
2016-887K130702
2019-9023K170818, K171295, K171595
2017-4746K131115
2022-2350FEI 1219343
2019-2704K108818
2023-6030K955650
2025-8605FEI 3011053282
2022-2990P130017
2015-7540K140751
2017-6329K111210
2021-4752FEI 2032493
2015-2290K120831
2018-5467K010911
2019-2115K181465
2018-5272K152061
2017-7047K152970
2018-242K170551
2025-2419K033326
2025-3848Form FDA 483, FEI 3010531069
2022-6010K191407
2019-7618K111285
2026-9156K261913
2023-223Form FDA 483, FEI 3005566046
2015-6362K030632, K040179, K123929
2024-9204Form FDA 483, FEI 2517077
2025-890Form FDA 483, FEI 5701
2023-9940Form FDA 483, FEI 2182208
2017-3643K160629
2025-24K240373
2015-2560K070173
2020-8640K122872
2020-6995K070423, K152525
2016-1417K033275, K120406, K143714
2022-504K210265
2026-6628K250781
2022-5429K111377
2015-6132K030419
2016-4116K151025
2016-3836K140516, K151398
2019-2510K172191
2020-4715K200952
2022-8848Form FDA 483, FEI 3021570645
2016-4645K040354
2026-8202Form FDA 483, FEI 2518417
2025-8226Form FDA 483, FEI 3009495876
2026-9335FEI 3003793491
2019-3732K092363
2015-10143K151525
2016-2644K133137
2023-4481K052099
2017-3936K063231, K113073
2019-705P150031
2023-1915K171294
2017-5114K091930
2016-8959K932122, K944319, K991473
2017-8241K140552, K141883, K151929
2020-1261K895901
2023-3384K180820
2024-9493Form FDA 483, FEI 3002836339
2014-9939K082848, K100889, K111119
2024-7381K233557, K233798
2022-7363EIR, FEI 1719513
2021-3337K203281
2020-7506K082748
2025-9327Form FDA 483, FEI 3012144557
2021-1398K161457
2023-2761Form FDA 483, FEI 3009973336
2026-8354K132021
2016-672K042065
2015-3435K122982
2020-2894K082296, K181197, K190819
2025-3324P990021
2019-5454K123954
2020-854K161991
2025-11361Form FDA 483, FEI 3029835193
2025-10733K833475
2025-11572EIR, FEI 3007666314
2021-4514K210484
2025-2564Form FDA 483, FEI 3007666314
2025-1538Form FDA 483, FEI 1021343
2023-3544Form FDA 483, FEI 3003550196
2018-9819P860003
2023-10085P160031
2018-8545K760894, K864503
2018-3226K001491
2021-7252K013086, K022124, K043527
2020-7673K040335, K122121, K170568
2019-9833K123365
2020-1076K182010
2017-5351K120956, K133907, K151692
2021-4822P080012
2020-3267K020537
2018-3746K070961
2025-9272Form FDA 483, FEI 1820334
2023-2954K091459
2019-642K142743
2017-8947K110486
2020-3231K163602
2023-10148Form FDA 483, FEI 3019101334
2020-144FEI 2028492
2023-6289Form FDA 483, FEI 3001620005
2017-363K143608
2023-11313Form FDA 483, FEI 1937531
2019-11751K770977, K850960
2022-7927EIR, FEI 3007475226
2014-8111K113220
2023-2420K191352
2014-9274K123014
2017-5750K053363
2026-5473Form FDA 483, FEI 2011068
2017-2586K091051
2021-7869K112800
2025-12171K241516
2026-8832Form FDA 483, FEI 3011292417
2018-781K962166
2016-6306K820878
2020-4426K091210
2018-6294K053363, K163355
2023-4811K202243
2023-2709K223144
2025-2266K110870
2016-8730K141619
2026-7248Form FDA 483, FEI 3007301207
2023-10430EIR, FEI 3001421318
2017-6660K122172
2016-5692K960167
2021-8741FEI 3005170966
2015-86K002154
2026-6058Form FDA 483, FEI 3003631744
2019-8155K160713
2025-1784EIR, FEI 1119779
2017-1727K070129
2018-8631K030554, K051123
2026-8823Form FDA 483, FEI 3003418325
2022-7938Form FDA 483, FEI 3004161147
2016-9722K082315
2016-4138K111736
2020-377K031018
2018-7665K180634
2024-6609FEI 3003736705
2022-2478K151790
2024-2128K080964, K083460, K091978
2023-8374K203459
2023-4477P160053
2025-8885K191828
2015-8540K033018
2018-612K170722
2017-507K160401
2025-10942Form FDA 483, FEI 3003058119
2022-3133K172179
2019-9113K162567
2017-6118K012352, K012805, K021746
2024-1048Form FDA 483, FEI 1924066
2016-2216K150977
2022-8553Form FDA 483, FEI 3003895865
2024-8137Form FDA 483, FEI 3006003617
2018-9983K163713
2017-5995K140155
2023-7022P100014
2021-606K180388
2017-226K141326
2014-7980K113119
2019-3722K182010
2017-6106K002329, K012277, K031463
2018-2908K003487
2019-1854K911627
2017-9118K131861, K141822, K152319
2021-4660K192207
2023-1263K211877
2024-3840Form FDA 483, FEI 3011567699
2016-3464K072522
2026-7266K220306
2019-6900P140023
2016-5189K092090
2023-8756K200990, K212494, K213096
2024-1572Form FDA 483, FEI 3020869111
2017-2944K855121
2015-7558K133983
2024-2275K231578
2017-9672P110033
2022-3975K102973, K152001, K170249
2019-4273K100786, K112205, K950566
2025-2009Form FDA 483, FEI 3001237796
2025-3856Form FDA 483, FEI 3012972516
2023-2462FEI 3002485711
2021-1647K061232
2023-7996Form FDA 483, FEI 3003768251
2025-3074Form FDA 483, FEI 3002806460
2014-8553K001678
2017-8866K160295
2023-7167K201672
2018-7531K171403
2018-6479K102925
2025-9046K021550
2026-8786Form FDA 483, FEI 3006430881
2020-4471K893901
2023-5889K934261
2022-5144K101889
2019-9701K150137
2023-5650K170505
2024-8708Form FDA 483, FEI 3002808845
2020-7902K130338
2023-6159FEI 3006990600
2015-3479K142282
2019-124K962533
2017-4410K963728
2023-3354K221131
2025-2422K160743
2019-7495K003909, K122288, K930511
2025-13185FEI 3009083745
2026-1376Form FDA 483, FEI 3001236549
2023-10464K203043
2021-7789FEI 1717046
2022-3028Form FDA 483, FEI 3008875046
2018-1171K760171, K770879, K772055
2020-3509K190834
2015-4562K062817
2019-3497K172394
2020-8630K173761, K190010
2015-4168K093845
2022-5250K212658
2023-1494K120781, K931464, K951721
2024-11073K230573, K232461
2015-7315K150012
2014-9554K091131
2021-7669K011827
2018-3497K150361
2018-860K132646
2026-5054Form FDA 483, FEI 1211177
2020-7794K181295, K191489
2023-2635Form FDA 483, FEI 3023245
2018-9547K142711
2022-4815Form FDA 483, FEI 3013424071
2018-6192K171566
2016-6994K091799, K092178, K120772
2018-5123K140910
2016-3849K152700
2016-4804K020518, K141742, K150499
2017-2824K032222
2017-5807K163430
2026-9121Form FDA 483, FEI 1220908
2019-7718K040977, K090283, K955936
2024-7001Form FDA 483, FEI 3005718570
2023-2261K121917, K142870, K190545
2017-1900K943230
2017-5799K021702
2015-129K050159
2026-4806Form FDA 483, FEI 3007219818
2018-9605K170039, K173634, K173670
2024-6841K961825
2022-930K212237
2015-4000K120296
2016-2692K112341
2026-1410Form FDA 483, FEI 3014308816
2024-7042K231470
2016-664K031539
2026-6085EIR, FEI 3011292417
2016-6874K071037
2016-6936K946276
2016-5931K093217, K131861, K133845
2014-9293K080550
2022-5320K192349
2021-169Form FDA 483, FEI 1000128562
2016-6996K040262, K080399
2021-1089K071807
2024-9124K033842, K034065, K832621
2018-7726K131855
2017-1438K152754
2021-4539K180233, K181180, K181295
2026-9107Form FDA 483, FEI 3007695749
2016-8110K030419
2016-7893K962545
2022-5477K092622
2014-8335K011236, K013695, K050344
2024-6943K043063, K090070, K152129
2015-128K102893
2015-6617K031571
2023-2274Form FDA 483, FEI 3009418685
2025-8198Form FDA 483, FEI 3005900820
2025-1815Form FDA 483, FEI 3003800209
2021-3443K093160
2023-2872FEI 4346
2015-4818K110686
2024-3531Form FDA 483, FEI 3013095415
2024-10513Form FDA 483, FEI 2016493
2015-2589K110069
2026-5839Form FDA 483, FEI 3008108789
2023-6320Form FDA 483, FEI 3010806467
2021-8684K200805
2017-5688K100831
2023-5194Form FDA 483, FEI 3014268427
2016-3489K050446
2025-986K143513, K163512, K181502
2020-7143K071629
2018-32K063379
2021-3685K904640, K913459
2025-7449Form FDA 483, FEI 3003059934
2019-6225K994328
2020-2765K091299, K092035, K110569
2015-9057K103692
2016-7641K942821
2022-2432FEI 3008808182
2016-9959K123985, K132092
2017-149K043380, K063044
2020-7147K142908
2019-10091K170150
2024-654Form FDA 483, FEI 3014982186
2026-6753Form FDA 483, FEI 3014585508
2018-6680K121629
2026-7267K220796
2023-4463K051509, K190651, K934261
2021-1487Form FDA 483, FEI 3001833549
2024-8902Form FDA 483, FEI 3001155023
2026-8096Form FDA 483, FEI 3001237796
2015-3167K102478
2022-7662FEI 3002808445
2018-943K162572
2021-4424K062008
2020-5619Form FDA 483
2018-234K140819
2023-10465K202752
2016-4647K070095
2020-7903K182967
2017-10120K070374
2016-7469K003759, K050702, K060554
2025-1918K081311
2024-7525K173681, K210344
2016-10475K033389, K051672, K053345
2022-7225K072757
2024-4572K903058
2026-1271Form FDA 483, FEI 3001236549
2025-8756Form FDA 483, FEI 3010042047
2016-4643K993569
2021-1580P130022
2026-4962Form FDA 483, FEI 3002614107
2017-3793K122160, K153657
2019-10112K160176
2023-9038Form FDA 483, FEI 3004120479
2023-6315Form FDA 483, FEI 1317759
2023-9516Form FDA 483, FEI 1819470
2023-2773FEI 2183553
2017-4518K041363
2018-5246K971794
2023-9983Form FDA 483, FEI 1819470
2023-9066Form FDA 483, FEI 3009065312
2023-5798K163223
2025-10946Form FDA 483, FEI 3003078093
2022-3039P060040, P100047
2026-4691Form FDA 483, FEI 3003428492
2021-3775K190160
2014-10013K141681
2017-3642K160949
2024-261K123803
2023-3188K201346
2022-6484K201808
2015-6350K110586, K110619, K113546
2026-4892K861751
2025-12195Form FDA 483, FEI 3012146457
2017-2361K160766
2025-8966K813182, K905663, K942454
2016-9772K925378
2018-9551K953577
2015-500K041242
2022-5434K172319
2023-11433Form FDA 483, FEI 3009169872
2024-6860Form FDA 483, FEI 3012883202
2017-9881K172604
2026-1788Form FDA 483, FEI 3014213973
2026-6765Form FDA 483, FEI 2000010846
2016-3052K093847
2016-8143K022617
2022-2151K173730
2016-6757K072076
2017-8236K142432, K152178, K171366
2021-3980K111426
2022-7517K190292, K193006, K193601
2014-9969K103480
2015-1977K942697
2020-5388Form FDA 483, FEI 3002806485
2017-5758K050216
2026-6176Form FDA 483, FEI 3002998723
2023-7625FEI 1220246
2025-4494K231667
2020-384K182963
2018-3021K163334
2016-6332K152055
2022-4035Form FDA 483, FEI 3013478062
2018-4153K171135
2020-7117K050187
2020-1824Form FDA 483, FEI 3006644670
2017-4119K163144
2021-6319K153605
2018-6507K153049
2021-4380K060389
2016-959K130393
2020-4331K013280
2022-8415Form FDA 483, FEI 1000513101
2016-5262K153239
2016-5513K033913
2022-7414FEI 3002806651
2016-6746K040010, K092623
2023-2769Form FDA 483, FEI 3014650073
2015-9229K100116
2025-14106Form FDA 483, FEI 3003673482
2023-5240EIR, FEI 2182207
2024-4346K073423
2016-6975K161507
2025-13019Form FDA 483, FEI 1039284
2023-3950FEI 3010123655
2017-2345K152086
2026-7383Form FDA 483, FEI 2017865
2016-3998K030902, K031673
2023-4462K160684
2018-697K030554, K090242
2020-161P040005
2021-366P110002
2016-7994K971130
2023-6798Form FDA 483, FEI 3011150327
2016-1725K003720
2026-7417Form FDA 483, FEI 3006794225
2018-1513K021737
2024-1506Form FDA 483, FEI 3008278458
2023-9129K182422
2021-945K131955
2021-8577K172335
2015-9577K964240
2019-10916K190090, K190792
2024-1962K202961, K212835
2023-84Form FDA 483, FEI 3003550196
2018-6679K121057
2024-1702Form FDA 483, FEI 3006073153
2025-1612Form FDA 483, FEI 3009205152
2023-5295Form FDA 483, FEI 3003224146
2019-2588P970003
2026-9336FEI 3003793491
2018-8648K944864
2014-8853K122480
2018-5031K050558
2015-1834K090001
2019-2333K180770
2024-608Form FDA 483, FEI 3021949949
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2022-1658Form FDA 483, FEI 3003046678
2017-5863K080788
2020-6821K072327, K100945, K130845
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2016-10566K152033
2016-8776K770428
2022-6321Form FDA 483, FEI 3012228452
2019-6918P110030
2018-9169K133701
2026-8781Form FDA 483, FEI 3009717300
2026-5589EIR, FEI 6005
2025-6975K181502, K240029, K240177
2017-2574K032392
2026-1246Form FDA 483, FEI 4488
2026-6792Form FDA 483, FEI 3000206772
2016-7067K031889
2018-8028K112314
2017-4412K121682
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2017-5945K163329
2015-5210K082057
2022-5185K101262
2022-4217K142983, K183636, K193576
2016-6550K160056
2020-5498K173510
2016-8439K060070, K063224, K093737
2025-13673FEI 3005949964
2017-8269K170984
2021-3686K032226, K073707, K092148
2026-7828Form FDA 483, FEI 3013634985
2023-2755K223144
2015-5271K071573
2017-6439K170724, K171255
2024-8193K233580
2023-5844K202536
2018-5971K170595
2017-8110K162759
2021-5271K033268
2017-8153K171331
2017-9276K170082
2023-3117Form FDA 483, FEI 3011184129
2017-4785K133265
2021-2949K073377
2025-4453K181980, K202327
2015-7101K121743
2024-1567Form FDA 483, FEI 1216783
2015-3377K101979
2015-8849K143527
2024-9673Form FDA 483, FEI 3010800486
2019-2623K171321, K171444
2023-10507K202182
2017-4772K042200, K070854
2020-7392K041393
2015-345K133578
2016-9271K964152
2022-6031Form FDA 483, FEI 3009882464
2018-9699P140009
2025-8323K241108
2023-9785K223209
2016-1979K021859, K061146, K870200
2015-7131K101386
2021-4026K053253
2015-6442K062868
2015-4064K142098
2017-10773K030573
2017-2682K141405
2022-447K181502
2025-11594K982597
2022-4021Form FDA 483, FEI 3014447708
2023-7270Form FDA 483, FEI 1925262
2020-1501P980025
2024-10654K170826
2016-6709K123555
2024-6117K081536, K092467, K191546
2026-8683Form FDA 483, FEI 1000121696
2025-3851Form FDA 483, FEI 1000518597
2018-7671K871157
2018-2268K152721
2024-813P040034
2026-6709Form FDA 483, FEI 3010890287
2021-165K102734, K152021, K153655
2015-9708K982256
2017-4864K071859
2022-345K203695
2026-5136Form FDA 483, FEI 2650089
2017-6752K080180
2015-10211K023098
2018-3386K142427, K161038
2019-11961K141769
2026-8012Form FDA 483, FEI 3011089437
2022-7711K051263, K072412
2023-8598K230857
2021-6594FEI 3019216
2021-6999K200918
2025-7677Form FDA 483, FEI 3014585508
2018-583K161469
2019-39K132496
2022-4011K131282
2025-1633Form FDA 483, FEI 3010079067
2023-2217Form FDA 483, FEI 1047429
2019-8226K122886, K140313, K141668
2024-9881K930748
2016-8586K052198
2019-3933K083695
2019-12067K183085
2024-9926Form FDA 483, FEI 1000120743
2016-6977K083707
2017-2132K062291
2017-6351K983102
2018-7257P100003
2020-6570K193559
2015-8630K031925, K992556, K994328
2026-7754Form FDA 483, FEI 1000119582
2016-4935K151650
2019-9154K143169
2018-7881K936304, K945531, K952030
2019-10646K060713
2023-10150Form FDA 483, FEI 3015151147
2014-9658K100669
2017-1249K083009, K093672, K150222
2019-8313K133279
2024-8176K223316
2021-292Form FDA 483
2025-3838K222786
2015-5670K130781, K143527
2021-472K180346
2023-9221Form FDA 483, FEI 3017718237
2017-5686K122528
2024-5133K173348
2015-5008K844401
2022-5249Form FDA 483, FEI 3007772056
2022-3929K190929
2022-4128FEI 3006846316
2026-8355K111595
2026-6239Form FDA 483, FEI 3003347293
2022-5914K040911
2023-10000K232852
2021-724K102861, K111458
2017-10026K120446
2025-12386FEI 3010144038
2016-7879FEI 6892
2019-98K180185
2014-8049K121932
2015-3254K093438
2025-2337K092886
2020-5954K090626, K091461, K121579
2015-9168K151971
2023-5487K113636, K131230, K141656
2019-6809K023723, K092283, K152960
2021-3038K210269
2015-5137K842754
2020-5739K051348
2017-5648P130014
2023-10036K213334
2022-2027K160084
2015-809K123369
2017-2031K161092
2017-4837K163415
2023-5115Form FDA 483, FEI 3008747271
2017-4954K160755
2024-4520Form FDA 483, FEI 1824619
2020-3477K170581
2021-3898K170165
2020-7687K072979
2017-6501K102329
2025-3303Form FDA 483, FEI 4395
2014-8177K080275
2018-5247K170957
2022-2136K161579
2018-5349P100006
2024-7440Form FDA 483, FEI 2212018
2017-8767K163431
2024-2529K984523
2021-7626K982838
2022-3777K200755
2022-5303K121917
2017-2597K150553
2023-2681K201525
2025-10736K223243
2021-7799FEI 3023245
2022-7667K212382
2025-3884Form FDA 483, FEI 1924066
2021-3183K132623, K151244, K162567
2015-1407K133672
2025-1864Form FDA 483, FEI 3015328411
2020-5224K093065
2016-7634K942823
2025-4271K211008
2016-9564K882174
2016-8165P100006
2016-1332K142359
2024-5643Form FDA 483, FEI 3016475736
2018-8151K152181
2024-9646K213954
2016-7595K162141
2021-3135K192101
2015-5563K132105
2017-6498K052848, K053527, K120737
2026-9379Form FDA 483, FEI 1220908
2023-9650Form FDA 483, FEI 3006575795
2017-662K101194
2026-5586Form FDA 483, FEI 1416980
2025-1505Form FDA 483, FEI 3011237770
2016-5511K991903
2025-12563K230722
2018-1225K082538, K111976, K162740
2018-7061P860004
2015-7325K080788
2022-7147FEI 3007772056
2019-4189K123910
2025-2190Form FDA 483, FEI 5539
2017-9796P030002
2016-9038K052194
2017-5360K023892
2016-3745K141953
2016-9698K042816, K132290
2016-9506K121936
2015-4910K992135
2019-11644K150445
2014-8757K102307
2020-7788K190693
2016-5283K132741
2024-4519Form FDA 483, FEI 3009690171
2019-1023K173619
2015-8965K010343
2024-3000K233227
2020-4517K182920
2020-8813K190070
2018-9589P820056
2025-2923Form FDA 483, FEI 3005196642
2023-4330Form FDA 483, FEI 1627186
2023-4025Form FDA 483, FEI 3002718545
2025-1000K181013, K203215, K222588
2025-11889EIR, FEI 3015871081
2016-8331K160237
2017-7255K802566
2025-10863K220122
2018-8528K172462
2025-14236Form FDA 483, FEI 3003063996
2025-13068EIR, FEI 1119779
2015-172K081480
2018-2053K120009, K151986
2014-8271K051197
2018-6531K760699
2020-7672K002629, K002633, K002705
2021-6762K182811
2022-7757Form FDA 483, FEI 1000115518
2018-3080K112692
2020-4980K002172, K002699, K010051
2025-12378FEI 3021902344
2023-9003K223263
2023-5770Form FDA 483, FEI 3003381355
2022-3073Form FDA 483, FEI 3016490370
2022-336K945794
2015-4217K142564
2017-872K163253
2018-744K131895
2022-6282K001409
2023-191Form FDA 483, FEI 1000136007
2022-6175EIR, FEI 1718850
2025-10676EIR, FEI 3009234552
2016-8127P100026
2022-2029K183290
2023-6335Form FDA 483, FEI 3007697249
2026-6310K253661
2018-2403K153239
2015-8093K845036
2018-9606K162914
2024-5129K142620
2025-1188FEI 3007134923
2023-11037Form FDA 483, FEI 3019101334
2014-10058K132148
2024-8386Form FDA 483, FEI 1000654629
2024-5131K082837
2023-9687Form FDA 483, FEI 1819470
2022-6581K192109, K202487
2024-8987K150174
2016-8595K152434
2015-5785FEI 4393
2015-1401K032222
2020-7158FEI 3926
2024-1050Form FDA 483, FEI 1000526834
2024-1349FEI 5468
2026-4917Form FDA 483, FEI 1000142899
2015-1975K902936
2023-2956K193135
2023-2226Form FDA 483, FEI 3009688114

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