Data catalog

FDA FOIA requests

About 15K records

More records

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

2023-10488Form FDA 483, FEI 3010867648
2026-2024Form FDA 483, FEI 1220648
2014-9790K961088
2022-8373Form FDA 483, FEI 3017936974
2021-852K203040
2015-6107K002149, K003016
2019-2227K173619
2023-10876K081536
2016-5030K111068
2017-1355K133243
2016-5932K101298, K120084, K152802
2020-4332K063159
2026-7584Form FDA 483, FEI 3012262584
2022-6780K221131
2026-6920Form FDA 483, FEI 1416980
2026-6057Form FDA 483, FEI 3029740697
2015-23K083580, K090042, K120500
2015-6321K913128
2015-6004K101133
2018-1347K832622, K843313
2026-9136Form FDA 483, FEI 3003676119
2024-7995K150222
2020-8198K051263, K071194, K072412
2021-949K143457
2020-3255K160942
2023-954K201543
2014-9775K103429
2025-2648K203362
2026-9353Form FDA 483, FEI 2112020
2017-100K121712
2024-1556K231826
2022-5553Form FDA 483, FEI 3009519707
2026-6776Form FDA 483, FEI 3027386225
2026-5477Form FDA 483, FEI 1000516428
2025-14301K051647, K220317
2024-8004K210365
2024-9672Form FDA 483, FEI 3005791808
2015-2699K113351
2015-1645K060224, K080737, K101450
2023-46K221574
2019-1402K150657
2014-9643K141742
2016-6675K014027, K101423, K990498
2019-94K130223
2026-8875Form FDA 483, FEI 1000142899
2023-9875K221603
2020-769K013094, K042686
2015-9179K000781
2020-8767K810037
2021-1457K032958, K131817
2019-1137K151793
2015-5282K142832
2019-4045K041331
2017-5859K081140, K142356, K160231
2019-6483K172935
2015-7917K080444
2021-3299K191718
2021-8689K203401
2016-622K003269, K033810
2020-6614K121655
2023-4511K211855
2019-8314K152434
2019-644K130921
2015-6597K083070
2019-4046K181759
2024-11055EIR, FEI 3005210579
2025-11925Form FDA 483, FEI 2020976
2022-8115K221183
2016-10441K052241
2025-9129Form FDA 483, FEI 3012102437
2026-6786Form FDA 483, FEI 1000117344
2018-1842K001350, K001374
2024-988Form FDA 483
2025-1844Form FDA 483, FEI 1000138339
2022-3154FEI 3007518363
2020-8325FEI 3004013603
2025-837K143253
2018-217K965252
2023-10467K203440
2025-7688Form FDA 483, FEI 3009638066
2016-8951K040658
2023-5086Form FDA 483, FEI 1220905
2017-10678K161882
2021-8091FEI 3926
2025-2371Form FDA 483, FEI 1000515493
2025-8467K241713
2020-4476K151979, K161138, K180109
2022-149K202101
2024-3841Form FDA 483, FEI 3003415347
2022-5261K200162
2024-9946K240376
2023-222Form FDA 483, FEI 3014273501
2025-3659K181787
2017-7664K162771
2023-8950K220660
2015-391K090421
2023-9546Form FDA 483, FEI 3015417614
2020-3956K122106
2018-5649K131467
2026-6505FEI 3002478693
2023-2446Form FDA 483, FEI 2250051
2014-9809K010847
2024-819Form FDA 483, FEI 3001617730
2017-9461K122801
2026-5145Form FDA 483, FEI 3002619777
2019-7987K173388
2021-4485K131895
2025-2309K234055
2025-4473K200587
2015-2824K920025
2023-10315K033801
2018-411K031786
2017-4138K151650
2015-3308K023254, K143182
2025-9545K220075
2015-1826K050016
2016-1165K143445
2019-728K180288
2021-5860Form FDA 483, FEI 3003572099
2025-647Form FDA 483, FEI 3014334038
2024-7449K001781
2017-7070K081439
2021-3673K193244
2023-2316EIR, FEI 3001451379
2020-1124K190382
2020-8357K060407, K063715, K080521
2023-9463Form FDA 483, FEI 3012787974
2024-6582K152223
2020-5627FEI 2011068
2017-5911K130281, K141759
2023-2174Form FDA 483, FEI 1000125215
2025-1302Form FDA 483, FEI 1000526882
2019-10221K163696
2018-3945K142596, K161667
2019-4334P150003
2022-7768Form FDA 483, FEI 3003328262
2025-1096K803181
2024-10997Form FDA 483, FEI 3002806503
2018-2166K050124
2021-2136K142556
2018-3676K800829
2015-6315K983483
2017-378K133502
2017-7662K152960
2019-6207K991637
2021-8609FEI 1000354384
2022-8026Form FDA 483, FEI 1000513101
2020-6320K172832
2025-329K182588
2024-8029K233666
2022-7519K002970, K020608, K153473
2022-7416FEI 3014766741
2019-8892FEI 6508
2024-5734K190898, K211840
2017-10363K141148, K142301, K150360
2016-655K030611
2020-5470K132441, K140501, K143380
2015-6937K050418
2021-8401K171565
2020-5223K161212
2019-6691K070978, K150028
2024-223Form FDA 483, FEI 3012234585
2026-6177Form FDA 483, FEI 1219592
2026-7825Form FDA 483, FEI 3003537036
2014-9621K090212
2016-10381K893334
2018-7952K153653
2026-4777Form FDA 483, FEI 3001675293
2020-2341K060057
2024-3154FEI 3001236616
2024-169Form FDA 483, FEI 1000306115
2021-4016K170008
2017-5637K143292
2023-2387K170364
2016-6464K111441
2015-6618K071378
2017-10692K023183
2025-1488Form FDA 483, FEI 3026523692
2024-2706K153372, K213220, K230518
2023-602K211620
2025-1755Form FDA 483, FEI 3010342616
2016-4336K993438
2020-5460EIR, FEI 6750
2022-5444K181240
2017-6996K102400, K160447, K161533
2025-7703Form FDA 483, FEI 3023158661
2019-3362K121917
2017-6991K161533
2023-2638Form FDA 483, FEI 3005248192
2016-3870K032164, K043529, K061328
2018-1307K974393
2015-2783FEI 3366
2023-6743FEI 3005955744
2024-1173K875076
2018-3218K963807, K990560
2023-6019K192088
2015-7400K950491
2020-6173K201056
2024-9883K983648
2015-2570K945835
2026-1641EIR, FEI 1045125
2017-6819P120002, P120020, P120022
2014-8042K052767
2020-5951K081385, K083538, K151313
2022-3810Form FDA 483, FEI 1810189
2017-2756K103345
2022-7457K062925
2021-1724K062672, K071178, K103595
2016-4799K003128, K133981, K953442
2022-1866FEI 3010707607
2023-1998K221590
2025-7280Form FDA 483, FEI 3020856747
2023-4441K230637
2024-4277K122566
2022-5478K131120
2023-7893FEI 3008367216
2024-8568Form FDA 483, FEI 2020372
2015-2973FEI 4460
2025-11843K221183, K240058
2026-7376K092627
2026-8306K250680
2018-7180K110599, K122698
2020-2950K100442, K110486, K131686
2015-8966K790388
2025-12564K222395
2025-2370Form FDA 483, FEI 1039284
2018-8898K060585
2014-8540K082391, K121481, K963204
2026-1411Form FDA 483, FEI 3029300753
2019-2412K182661
2025-9547FEI 3005949964
2019-10312K101428
2026-5265Form FDA 483, FEI 3000717606
2015-4839K030982
2017-6456K073166
2019-10797K080442
2018-4508K963141
2020-7724K192764
2015-954K140845
2021-8125K827501
2017-6656K093447
2023-9001K122880
2022-5143K201290
2025-1652K193263
2019-3400K182768
2019-3701K142647
2016-10131K080525
2019-8678Form FDA 483, FEI 4488
2016-405K142463
2023-11529Form FDA 483, FEI 2433615
2019-1694P160030
2024-8192K233496
2016-4500K103346
2021-8452K200298
2025-11417Form FDA 483, FEI 3003007868
2023-7787K182819
2014-8448K122288
2018-2141K171295
2018-26K082898
2019-2798K172545
2025-9504Form FDA 483, FEI 2183744
2025-1003K780326
2020-3964K133385
2021-7079K132904, K171565
2016-5670K811528
2025-14341K231802
2025-13222Form FDA 483, FEI 3004753838
2020-4321K022077
2025-1002K760882
2015-6373K150776
2017-10803K980548
2026-7292Form FDA 483, FEI 3007895168
2017-4565K161865
2019-2902K072834
2017-2635K001241, K853585, K931154
2022-2817K193407
2022-1246Form FDA 483, FEI 3011233554
2018-1797K831000
2026-8630K172492
2015-8310K991668
2019-2880FEI 1841
2016-3217K022774, K070910
2022-1583K131401, K153501
2025-12385FEI 3002795782
2019-4644K981645
2026-6457Form FDA 483, FEI 3029926469
2024-2278K911422, K911425, K924100
2024-2291K222658
2020-6023K924970
2026-5917Form FDA 483, FEI 2450054
2018-1568K041007
2017-5908K011625
2018-3393K153542
2023-5105Form FDA 483, FEI 1220701
2015-2243K063310
2022-6682K163548
2020-3421K142385
2021-6794K080863, K083343, K090168
2017-5363K123527
2020-4469K780181
2015-6326K150912
2019-4658K171167
2025-2606Form FDA 483, FEI 3019856272
2023-10146Form FDA 483, FEI 3007093114
2016-10293K142361
2015-3587K093223
2017-10153K052692
2025-8833Form FDA 483, FEI 3001665800
2014-8067K132749
2023-5728Form FDA 483, FEI 3010041693
2016-3608K123999
2026-8588Form FDA 483, FEI 3027500452
2015-1410K091292
2016-3055K061467, K073547, K090791
2016-4723K983119
2024-10649K151041, K190651
2014-9977K121213
2018-8556K010052
2017-6203K993120
2021-5210K003090
2023-4648K203004
2020-2701K190461
2026-8088FEI 5988
2025-13003FEI 3005949964
2022-7191Form FDA 483, FEI 2545
2015-1948K952974
2024-5589K143513, K181502, K182075
2015-263K141520
2024-3144Form FDA 483, FEI 3005488132
2022-2500K212153
2023-6823FEI 1220246
2015-537K131799
2021-2218K923862
2026-4805Form FDA 483, FEI 1811396
2026-9118Form FDA 483, FEI 1220908
2019-2317K062166
2023-5859Form FDA 483, FEI 3009241418
2021-2703K050311
2018-5778K132951
2019-6216K063178
2025-2384FEI 5864
2024-5830K240297
2015-6449K052931, K070173
2025-4465K150852
2023-3763Form FDA 483, FEI 3015489145
2017-3697P150029
2020-5359FEI 1925262
2024-5014FEI 3008904416
2024-1188Form FDA 483, FEI 3002983930
2026-1093Form FDA 483, FEI 3003218906
2026-1695EIR, FEI 1000136573
2015-6763FEI 6034
2025-3890Form FDA 483, FEI 3029582858
2021-3438K083343
2024-8733K232936
2022-951EIR, FEI 4395
2020-8444EIR, FEI 3022472
2014-9242K911278
2025-11697Form FDA 483, FEI 405
2016-3332K090661
2020-8523Form FDA 483, FEI 3009543051
2019-10440K090626
2025-7720P140029
2022-5485K190005
2025-1080K961055
2026-5567K890492, K893042, K894747
2014-8162K132834
2020-8633P030017
2014-8170K122817, K131255, K141573
2020-6820K024249, K110771, K113422
2015-9866K000722, K011997, K012771
2016-7702P080027
2017-10742K141929, K163099, K171230
2015-5070K011702
2022-2322K192176
2023-4487Form FDA 483, FEI 1000522032
2026-5361Form FDA 483, FEI 3025308469
2024-8157K171671, K183081
2020-2505K082474, K183437, K192764
2018-6241K100635
2026-9372Form FDA 483, FEI 1220908
2023-3856K123563
2023-7133FEI 1220246
2016-10295K132376
2023-5848Form FDA 483, FEI 3010331770
2015-4809K844504
2016-6733P010030
2021-3606K200948
2022-1081K200761
2019-9591K001337, K031649, K120053
2025-14345K953174
2025-2341Form FDA 483, FEI 2242327
2021-1576K192007
2015-10229K140459
2021-4300K150880
2017-6537K160474
2021-3295K060061
2023-10472K143147
2015-2373K102909, K111066
2023-9994FEI 1819470
2024-7406Form FDA 483, FEI 1025114
2026-6570Form FDA 483, FEI 3008034930
2022-8417K183385, K212871
2018-6606K152304
2019-7832K190792
2018-9264K170876
2017-9542K163586
2018-9937K082474, K152547, K171581
2022-7505K222059
2025-2608K113862, K121319, K202365
2026-1051K090885, K110285, K141731
2015-2360K983436
2023-2715K223144
2020-5327K200240
2019-9773K124043, K150462, K161768
2015-100K040977
2023-373Form FDA 483, FEI 3016838734
2015-5013K982083
2021-1102K151296, K161458
2019-3613K182720
2016-10298K121446, K121455, K121461
2021-656K193670
2023-8998K030596
2016-6409K132447
2021-164K161355, K171610, K172356
2025-10205P990074
2026-7502Form FDA 483, FEI 1000517901
2015-1976K922688
2016-3538K931265
2015-4767K140415
2015-8087K101952
2025-2630Form FDA 483, FEI 3003945344
2022-4853K173574
2018-864K160501
2026-8356K112783
2014-8055K945271
2017-2976K153345
2025-10342FEI 3001451489
2020-648K181084
2015-2092K800101
2015-6324K123212
2015-1131K080966
2017-5930K130123
2017-3560K100160, K140190
2014-9189K030281
2019-3220K151499
2019-1779K081917, K113447, K132368
2016-2402K141410
2024-2448EIR, FEI 1819470
2024-400Form FDA 483, FEI 3005841027
2021-5710K940025
2019-10635K043032
2020-1201K973462
2021-664Form FDA 483, FEI 2530154
2024-10648K212815, K223348, K911802
2018-1069K781693
2019-8212P100006
2015-7674K132839
2017-3815K101522
2020-8537K063349, K172085
2018-6369K180151
2016-7529K110332
2017-2594K820227
2023-7621FEI 3010331645
2025-12376FEI 3009493875
2026-5397K234088
2015-6644K141929, K150910, K151236
2014-8526K121700
2015-751K974020
2019-6227K190185
2023-4252Form FDA 483, FEI 1000138447
2023-10199Form FDA 483, FEI 1220423
2022-3072Form FDA 483, FEI 3007183151
2020-1723K936108, K951901, K954140
2021-1912K133957
2023-2810Form FDA 483, FEI 3002805559
2019-747K896017
2024-9743K180817
2025-10729K885138
2022-6964K182149
2023-7888FEI 2245654
2023-1088EIR, FEI 3009534409
2018-4394K063435, K946106
2015-3749K150615
2024-3678K181660
2019-6989K150776
2014-9400K113229
2025-8202Form FDA 483, FEI 1937531
2016-4661K001989
2015-45K041934, K102893, K132560
2023-3092K053646
2023-4674K190780
2019-563K040855
2023-10205Form FDA 483, FEI 2939653
2018-4221K082089
2020-2967K130468
2025-12503Form FDA 483, FEI 3006575795
2026-1630K160231
2018-8153K150611
2019-5181K173727
2015-8281K080108
2021-6111K963376
2025-10202K232460
2026-6459Form FDA 483, FEI 3022977716
2023-8470Form FDA 483, FEI 3023229437
2015-2970FEI 4430
2018-8721K143740, K160958
2021-206FEI 5711
2015-3577K023543
2017-5052K121735
2022-1005Form FDA 483, FEI 2650089
2016-729K124031
2015-5275K150563
2015-543K141220
2025-3538EIR, FEI 2183715
2024-906Form FDA 483, FEI 3025301749
2025-8945Form FDA 483, FEI 1417519
2019-566K072549
2015-5825K053622, K090078
2018-106K162594
2015-7086K912472
2019-8940K081439
2024-5727K061711, K103260, K113808
2018-2252K153754
2025-3647Form FDA 483, FEI 3001237796
2017-1357K143405
2024-7695Form FDA 483, FEI 1000222013
2018-1026K150078
2022-7273K210478
2023-5727Form FDA 483, FEI 3009727738
2017-8793K030947, K121048, K140472
2017-170K990687
2015-6994K001828, K032005, K991936
2016-8814K151964
2017-5679K142491
2020-2467K192891
2016-7785K113104
2015-7477K031838
2024-3554K182408
2016-2476K112316
2015-669K930933
2019-8179K190160
2020-3497K191529
2026-7965Form FDA 483, FEI 3027031650
2020-4588K180818
2025-11926FEI 3007096749
2018-5606K103529
2015-1974K871358
2025-13728K072049, K101123, K140312
2021-7881K011208
2023-8809Form FDA 483, FEI 1819470
2023-3033FEI 6362
2020-6500K191666
2023-9035Form FDA 483, FEI 1819470
2026-4472Form FDA 483, FEI 3003640911
2023-2084P030002
2023-6450Form FDA 483, FEI 1000138447
2016-3340K132447
2016-3447K001450, K121194
2025-9297K151208
2016-6743K020698, K942597, K982428
2018-8435K133566
2023-6769Form FDA 483, FEI 3007965489
2026-6453Form FDA 483, FEI 1527607
2024-8169K092849, K093297, K200107
2019-3267K101734, K120766, K121765
2021-5669P100010
2019-11257K132886
2025-2350K190542
2020-1422K160252, K191679
2017-4715K031636
2021-207K082051, K111576
2026-8741K882658
2025-13977Form FDA 483, FEI 1000521505
2022-8713FEI 3009144084
2019-5054K151461
2025-11213Form FDA 483, FEI 3011292417
2015-8880K143086
2022-8378K213334
2026-1681Form FDA 483, FEI 1720734
2014-9006K121484
2014-8279K042648, K063788, K110189
2014-8714K120187
2020-418P020056
2023-5601Form FDA 483, FEI 3002907620
2017-3228K014087, K022548, K034052
2025-11966FEI 3010934853
2022-1605FEI 3003399824
2014-8549K112226
2022-7751Form FDA 483, FEI 1050373
2014-9072K130943
2025-3867Form FDA 483, FEI 3012972516
2026-1623Form FDA 483, FEI 3004161147
2023-2067Form FDA 483, FEI 4324
2015-3868K051338, K150174
2019-4411K190182
2023-386K180481
2025-2645K242323
2015-9467K061247
2021-5902Form FDA 483, FEI 7300
2018-10313K133865
2017-3106K160538
2022-1627Form FDA 483, FEI 3009751352
2016-4024K024180
2019-2867K183592
2014-9832K122288
2023-7639K193552
2018-4275K131249, K151650, K991513
2020-3878P000005
2016-9039K142922
2015-8299K133800
2018-9550K091659
2025-4549Form FDA 483, FEI 3023855046
2025-4414K180346, K230199
2017-8079K132375
2021-7636K200667, K200774, K202285
2020-5090K200795
2022-7518K062049, K150230, K150724
2015-4438K140497
2018-4898K094038
2025-8907Form FDA 483, FEI 1000120505
2019-731K800563, K851082
2023-9939Form FDA 483, FEI 3003166194
2015-5942K021362
2022-2984K212265
2017-5555K132323
2022-4809Form FDA 483, FEI 3015937270
2019-6229K143380
2025-3732K973865
2026-6164K081984
2021-5066K131401
2020-8864K191606
2019-6493K042290
2019-5021K171626
2023-5207K180367
2018-8730K170070
2017-3903K140388
2023-916Form FDA 483, FEI 3008778066
2023-7593FEI 3001155023
2014-9967K133521
2016-4852P980048
2023-11196Form FDA 483, FEI 3001665800
2024-6702Form FDA 483, FEI 3002783962
2023-2218Form FDA 483, FEI 1000221992
2025-859FEI 3012823434
2015-5394P850007
2023-4439K102581, K173281
2023-3894K945952
2017-10122K162608
2023-9279K030952
2014-8743K100577
2023-598Form FDA 483, FEI 1000151124
2021-1801K162877
2014-9141K103437
2021-3481K200077
2015-10061K024033
2026-1897Form FDA 483, FEI 3006537560
2026-7374Form FDA 483, FEI 3009336980
2016-5939P950022
2019-10906K993735
2014-8552K041551
2023-9311EIR, FEI 3004363352
2014-9800K012078
2019-3472K961749
2024-7258Form FDA 483, FEI 3021769057
2017-1918K131897, K140847, K152491
2022-3006P010003
2022-4551K121917, K142870
2026-9322K211838, K254056
2021-8089P110008
2023-7318FEI 3003708273
2026-8001Form FDA 483, FEI 3002808086
2014-8736K093677
2025-14223FEI 1220246
2020-2884K160309
2020-3951K170023
2024-383EIR, FEI 6750
2015-5937K061855
2016-2105K946147, K950339
2019-2211K063723, P140003
2021-3330K192863
2024-375Form FDA 483, FEI 2020372
2025-12639K984208
2015-9350K002827
2025-13403K232107
2016-1912K100144, K122766
2021-728K110458, K173544, K182296
2017-402P850007
2021-8509K142327, K191340, K210484
2016-4669K150563
2026-8918Form FDA 483, FEI 3014527928
2021-4352Form FDA 483, FEI 3012539501
2018-82P140003
2025-2293K241891
2022-3576FEI 3009543051
2016-2046K113202, K143484, K152070
2020-4468K770704
2022-380K200247
2020-5227K102511
2023-10887Form FDA 483, FEI 1824206
2021-6449Form FDA 483, FEI 3006695864
2024-9664Form FDA 483, FEI 1000049086
2024-6435Form FDA 483, FEI 3017140511
2020-3240K163566
2025-7937Form FDA 483, FEI 3010166880
2016-8075K100152
2018-2556K151363
2020-3471K162594
2018-2651K162503
2025-11607Form FDA 483, FEI 1000120743
2016-747K141757
2022-4575FEI 1721676
2015-4819K133868
2018-5626K150465, K181001
2023-8220Form FDA 483, FEI 3003694926
2015-3274K922789
2025-2444K903316
2014-8267K110172
2019-12071K083452
2018-5244K131305, K150861, K162172
2019-10165K003323
2024-236K092467
2026-9388Form FDA 483, FEI 1220908
2019-5150K181461
2024-9176Form FDA 483, FEI 3009253624
2017-10192K033257
2025-4675Form FDA 483, FEI 6425
2017-6535K103087
2023-2235P150017
2018-7973K150815
2026-7498Form FDA 483, FEI 3010806039
2017-5226K120033
2022-4813Form FDA 483, FEI 1000474105
2016-5567K092342
2015-1213K810310
2025-4205Form FDA 483, FEI 1000138339
2025-12629Form FDA 483, FEI 3014527966
2023-8371K895920
2022-3111K202830
2016-4936K131962
2017-4726K032519, K060980
2021-215K151071, K183634, K183646
2018-6286K172593
2026-8148FEI 3004209178
2023-505Form FDA 483, FEI 3011277306
2015-5253K142282
2016-4764K100066
2019-7498K003033, K012078, K961088
2016-707K990291
2021-8237FEI 3926
2021-7735FEI 3007772056
2014-9212K092381
2022-722K182964
2017-990P890057
2017-4906K051967
2023-560Form FDA 483, FEI 2242352
2016-9907K103175
2023-9624Form FDA 483, FEI 3005488132
2025-12178Form FDA 483, FEI 3005737891
2024-3642FEI 3011158388
2026-9361Form FDA 483, FEI 3003793491
2024-5733K131222
2019-7372K183091
2023-10342K200667, K213037, K221183
2020-8256K040998
2016-8129K141119
2025-8474Form FDA 483, FEI 2434141
2015-7489K051926
2026-6807K223608
2018-5152K041112
2025-7777Form FDA 483, FEI 1000138339
2023-6722Form FDA 483, FEI 1000221653
2023-5394K862810
2018-5175K132119
2015-1333K133057
2024-2126K152938, K170469, K170790
2016-3921K122470
2016-1237K090145, K130002
2016-1916K063367
2015-8133K022447
2016-8817K152926
2015-10259K013928
2017-177K080788
2022-5868K002519
2015-6317K993455
2023-5769Form FDA 483, FEI 3003768921
2019-10794K190332
2024-5221Form FDA 483, FEI 3008581796
2021-2297Form FDA 483, FEI 3010536692
2017-227K153289
2025-14342K214048
2016-5146K141440
2017-10817K132306
2024-5222Form FDA 483, FEI 3020460367
2026-8007Form FDA 483, FEI 3002807310
2022-1631Form FDA 483, FEI 1818911
2023-562Form FDA 483, FEI 3008501562
2019-9543K171120
2023-2096P030002
2015-3476K133997
2020-1955K003927
2018-470K111010
2014-8219K083833
2021-6210Form FDA 483, FEI 3000279201
2022-5480K172726
2022-4819Form FDA 483, FEI 3003166194
2019-7706K060298, K061373, K080587
2023-5729Form FDA 483, FEI 1000222372
2024-2527K974837
2023-6404K200065
2022-7787K161756
2021-3273Form FDA 483
2015-5629K090034
2025-1149Form FDA 483, FEI 1220423
2019-8960K110605
2016-5961K030688
2017-7336K983831
2017-5668K170263, K170992
2015-58K040971
2017-3208K090725
2022-7758Form FDA 483, FEI 3017065027
2021-6197K203722
2021-7995P040027
2018-5523K160192
2024-6891Form FDA 483, FEI 3005021665
2020-3202K163180
2015-9207Form FDA 483, FEI 2926
2025-1910Form FDA 483, FEI 1220246
2025-12010Form FDA 483, FEI 3002807108
2026-9163FEI 1220908
2026-4379Form FDA 483, FEI 3003075526
2020-1369K181822
2018-4456K160524
2015-3553K090224
2018-5488K161789
2014-10056K993107
2025-11089Form FDA 483, FEI 1025114
2024-9925Form FDA 483, FEI 3001451489
2016-10006K161640
2023-5187K212815
2026-8681Form FDA 483, FEI 1220394
2023-10301P160031
2025-7029Form FDA 483, FEI 3001048992
2022-7404K200599
2026-7932FEI 3001592626
2017-7447K171331
2015-2708K051681
2025-79K230130
2020-2201K001293, K010139, K023914
2026-2037FEI 2243471
2022-4195FEI 3002087856
2023-10730Form FDA 483, FEI 3011656326
2015-6909K150089
2019-10060K172520
2015-7106K093624
2020-2480K161298
2022-4460K133209, K191804
2019-11149K162219
2021-4743K210544
2025-2394FEI 2828
2024-2413K190962
2022-5509Form FDA 483, FEI 3007772056
2017-4805K081990
2015-2706K822068
2021-5686K201782
2016-7784K081635
2023-2807Form FDA 483, FEI 3005012805
2025-12808Form FDA 483, FEI 3009566827
2022-6681K201696
2017-1568K070628
2024-6524K231325
2015-7308K080779
2015-3285K110212
2015-3447K133355
2025-14142K093934
2017-1164P040046
2023-4369K180578
2023-9020Form FDA 483, FEI 3001451489
2025-10197Form FDA 483, FEI 3014345398
2016-5920K160511
2023-4488Form FDA 483, FEI 2183613
2022-7772Form FDA 483, FEI 1000513101
2015-1693K091158
2016-4007K062795
2015-5025K111377
2021-8691K211129
2025-1085K911387
2018-5767K063091, K130943
2024-4866K233952, K241178
2025-2351K193371, P150017
2022-4973P150001, P160017
2021-333K200698
2023-10374Form FDA 483, FEI 1010370
2018-8407K760822, K812810
2026-8015Form FDA 483, FEI 3008724689
2017-2030K140533
2025-9544K022357
2016-8158K101677
2015-2104K092239
2018-9113K163234
2023-7145K222210
2017-5797K161885
2023-1269K160068
2017-3704K161433
2021-1394EIR, FEI 1220477
2025-6965K161014
2023-5298Form FDA 483, FEI 1000149660
2023-5333Form FDA 483, FEI 3005070406
2020-6638K171120, K192803
2015-2286K143314
2026-5333K945954
2025-1802K192928
2021-8882FEI 3003769089
2019-9390K160537
2022-5215K020608
2024-11207Form FDA 483, FEI 1037230
2024-758Form FDA 483, FEI 3002806457
2016-2141K980853
2023-9907Form FDA 483, FEI 1819470
2022-2900K172007
2015-8473K120388, K133174
2019-2110K173493
2016-8667K033566, K051958
2015-1575K881917
2015-7966K801969
2023-7798K150160
2019-10539K170059
2017-3185K130874, K141456, K162176
2021-6843K071973
2025-2207K210136
2019-9535K162762
2017-8940K131686, K143213
2025-2461K233700
2026-1492Form FDA 483, FEI 3009546466
2023-7536Form FDA 483, FEI 3016667340
2016-9119K831004, K833026
2021-3360K163154
2021-176K041007
2025-328K153745
2024-8701K242066
2021-7038Form FDA 483, FEI 1819470
2021-2774K032147
2017-2749K062779
2015-6494P010014
2024-9561Form FDA 483, FEI 3002836339
2025-10776K053379, K080445
2016-8125K031128
2021-3017K143120
2022-3046K212522
2021-2221K954880
2017-10746K984220
2022-6815Form FDA 483, FEI 1000123978
2015-7457K002931
2020-5578K200774
2021-6465K030239, K173300, K173761
2015-8334K042605
2018-9570K063582
2018-6136P160048
2024-9413Form FDA 483, FEI 3011913386
2015-10058K131131
2022-2358FEI 3005581270
2017-9760K080964
2022-1244Form FDA 483, FEI 7300
2015-8134K000783
2016-9365K161882
2021-4935Form FDA 483, FEI 3013111692
2024-4184K203517, K211733
2022-8059K934065
2019-4404K180161
2025-4506Form FDA 483, FEI 7300
2024-6120Form FDA 483
2026-6292Form FDA 483, FEI 3002807722
2025-11245K192774
2024-6427Form FDA 483, FEI 3004453700
2024-9867K202300
2014-9142K093128
2022-6594K143563
2024-4751K041163, K133783, K133829
2019-33P970051
2018-8675K110193, K982182, K983471
2024-9615K111738, K132109, K182422
2024-4736K213846
2016-3036K963305
2020-71P160030
2017-8324K031327
2022-5176K072113
2017-7836K091321
2024-2605EIR, FEI 3009493875
2017-10447K945120
2018-9996K043380
2019-8947K132817, K141141
2022-2683Form FDA 483, FEI 3004161147
2023-7986Form FDA 483, FEI 3010900508
2025-12006K140630
2016-9214K102242
2024-6299K190764
2025-8200Form FDA 483, FEI 1025114
2024-4859K964066
2024-11286Form FDA 483, FEI 3010201075
2017-7663K130975

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