Data catalog

FDA FOIA requests

About 15K records

All records

Every FDA FOIA request record published by Orca1, 1000 per page. Each page lists the record id and its name; open a record for key facts, related records and what Orca1 adds.

2023-2175Form FDA 483, FEI 3011501361
2025-11195Form FDA 483, FEI 3010892830
2025-3895Form FDA 483, FEI 3011271964
2020-4531K200366
2020-2633K183647
2022-170FEI 3006946288
2023-8056FEI 3010273872
2021-5932K120600
2017-10452K141752
2023-7672P100040
2015-10257K121248
2015-425K033333
2014-9753K041543, K042257, K050559
2016-7547K120995
2022-6575K932122, K944319, K991473
2021-5722K071959
2025-13720K010265, K031949, K051670
2021-3457K133626
2025-3864Form FDA 483, FEI 3007237389
2016-6872K072222
2014-9656K093695
2019-11712FEI 2981
2015-1087K110895
2023-6285Form FDA 483, FEI 3008175374
2018-5476K140882
2019-9531P820083
2023-5829K191352
2016-8322K153707
2021-4800Form FDA 483, FEI 3004377820
2017-2451K091326
2022-6030Form FDA 483, FEI 3013820501
2019-12073K071732
2019-1707K111831
2017-6512K080202
2023-3792K092011
2023-4401FEI 1000117344
2025-9628Form FDA 483, FEI 3004369035
2018-4894K120578, K133386, K160895
2017-4769K163141
2021-282K081532
2015-3566K140980
2019-2694P990081
2019-4619K180570, K182680
2019-11074K102400, K151834, K152332
2021-4903K191407
2023-3758Form FDA 483, FEI 3023229437
2025-6966K240029
2018-2924K842233, K892059, K960425
2015-7657K002630
2026-4932K211333
2024-11153K994339
2023-5620P080012
2024-8115K230681
2024-8117K233995
2018-4147K140190
2024-4053FEI 1000535235
2026-6407K202430, K251224
2016-7521K991786
2022-8543K141801, K160016, K160240
2023-104K213854
2018-5726K063049
2023-2270K212143
2019-7477K190277
2019-4951K020801
2015-9257K092117
2025-2573Form FDA 483, FEI 3004753838
2015-5669K132413
2022-4046K083292, K180165
2021-142K830009
2024-2860P070001
2023-61Form FDA 483, FEI 1719513
2016-10005K160449
2015-1623K043371
2015-5073K120479
2021-6450Form FDA 483, FEI 1627487
2026-1239Form FDA 483, FEI 3010680515
2022-6392K143459
2026-9374Form FDA 483, FEI 1220908
2023-5931Form FDA 483, FEI 3004185580
2023-4003K151904, K172574, K181603
2026-9179Form FDA 483, FEI 3007215524
2021-869K040657
2023-10029K021932, K150017, K161210
2019-10936K143690
2022-4722K212871
2020-4857K850051
2014-9528K091216
2026-9053Form FDA 483, FEI 3014485094
2022-4026Form FDA 483, FEI 3012316249
2017-4374K072618, K120242, K162467
2015-1449K003940
2017-10146K101786
2022-3926K182741
2025-7975Form FDA 483, FEI 3014585508
2016-7457K153249
2015-6145K113259
2017-9033K101535
2017-9674K124043
2020-8567K050114, K122652
2025-11359Form FDA 483, FEI 3012322979
2016-2728K083093, K113657, K122121
2021-3777EIR, FEI 2129284
2017-6148K123270
2021-3452K120917
2018-9314P850038
2025-1556Form FDA 483, FEI 3005669319
2022-7139K902783
2016-3300K091608
2020-3754P830035
2024-9064K082455
2021-3440K090891
2021-2702K192887
2024-6895Form FDA 483, FEI 3021769057
2020-7505K050311
2023-9346K182902
2017-8599P160030
2023-2475K182036
2016-7003K083873, K110914
2022-3088K951721
2025-307Form FDA 483, FEI 3029582858
2020-8536K163306, K180454
2024-6103K163622
2019-8223FEI 6664
2014-9482K052267
2018-3454K100268
2016-3037K873422
2021-5930Form FDA 483, FEI 3007772056
2016-7230K122205
2024-7087Form FDA 483, FEI 3010849408
2020-7946Form FDA 483, FEI 2124215
2015-1858K022140
2015-3321K091168
2018-1121K170568
2023-3852FEI 3003347293
2015-9K071202
2024-8969P980040
2022-5894FEI 3942
2025-502Form FDA 483, FEI 3011175548
2021-7778K180129, K182766, K190948
2024-7402Form FDA 483, FEI 1000517638
2017-6536K924408
2019-1051FEI 2027111
2020-4772K173402
2026-7428Form FDA 483, FEI 3011422544
2020-5646K102971
2018-9670K181643
2023-8194K203429, K223046
2014-8547K112181
2023-4240K030674
2015-1997K142915
2019-3442K012232
2015-7889K062842
2026-5256Form FDA 483, FEI 3015177815
2020-7005K090288, K131467, K163127
2015-4183K061201
2020-6888K173761, K190010
2024-10445K232111
2022-3244K162784, K163069, K200163
2017-6150K111520
2019-6210K971745
2019-10227K152926
2025-1502Form FDA 483, FEI 2939520
2019-11905K132343
2015-1885K130921, K142743
2021-3298K190784
2023-2523K101889, K161361, K190442
2023-2718K213815
2024-6991Form FDA 483, FEI 3007208829
2021-5644K171135
2025-426Form FDA 483
2014-8462K901348
2024-4157Form FDA 483, FEI 3011683976
2023-2169Form FDA 483, FEI 3008216220
2025-1954K102912, K132578, K213398
2019-2717K133542, K150799
2022-8737FEI 1419652
2015-859K033761, K042231, K083091
2016-1103K083763
2015-766K053452
2018-3880K160684
2026-8715Form FDA 483, FEI 3005949964
2021-6792K141983, K143457, K163105
2015-1077K123999
2015-91K891773
2014-9979K111250
2026-8760FEI 3020347218
2016-231K151025
2023-10038K212835
2022-5484K140464
2019-940FEI 3009809074
2015-441K024148
2017-9374K040298, K051799, K984058
2016-9891K983067
2022-892K070854
2015-4435K123300
2016-4612K150618
2020-2935K895631
2018-9139K180474
2020-6645FEI 9612007
2022-8203FEI 3001451801
2025-11255Form FDA 483, FEI 1000221463
2025-13253FEI 3004167615
2024-1950Form FDA 483, FEI 1000121370
2022-3898K210575
2017-6305K002884
2017-1335K143364
2026-8859Form FDA 483, FEI 3003347293
2015-336K120532
2022-5779K121698
2023-2743Form FDA 483
2026-9104K011489
2025-2324K242076
2023-7350K200878
2016-991K052168
2024-2525P960009
2021-6446K201778
2019-1568K150476, K181784
2024-1554K232380
2022-6627K173274
2024-2207K151790
2021-6215K061916
2022-4690K011827, K143054, K171565
2015-3941K926104
2024-456Form FDA 483, FEI 3015528146
2020-6994K920025
2018-618K011135
2017-9265K802146
2017-1079K162513
2016-8159K030427
2025-14392Form FDA 483, FEI 3004932373
2019-4229K033488
2017-3476P120005
2021-3406K162383
2018-4674K173317
2019-7871K170470
2016-10294K142085
2016-9704K161768
2023-4406Form FDA 483, FEI 1000125771
2026-1644Form FDA 483, FEI 3009437400
2016-8086K143372
2015-185K140187
2021-1876K143630
2019-4340K161314
2025-1097K812241
2026-1952K241663
2021-1692K181739
2025-10386Form FDA 483, FEI 3010892830
2020-4292K875144
2016-8535K150799
2020-8001K022011
2016-10140K141117
2015-10235K112817, K131944, K152040
2023-4132K093479
2025-639Form FDA 483, FEI 3011015568
2026-5989K250655
2015-6215K954167
2019-1366K110389
2021-6234K172772
2023-5802K980298
2026-8417Form FDA 483, FEI 3001237796
2016-9230K041219
2026-8623Form FDA 483, FEI 3008585473
2026-5480Form FDA 483, FEI 3010256111
2024-7577P220026
2017-867P160031
2016-4973K133276
2025-8626Form FDA 483, FEI 1925262
2023-1593Form FDA 483, FEI 3013403214
2016-5544K053110
2018-8855K173629
2020-7264K143716, K172206, K181799
2020-5040Form FDA 483
2024-9769K232699
2016-8723K133016
2025-11235FEI 3019216
2026-5973Form FDA 483, FEI 1216602
2016-4615K991568
2018-3099K173682
2019-38K172772
2023-2888K220205
2023-5894FEI 3009380063
2026-5644Form FDA 483, FEI 5468
2023-10348K231168
2019-3951K150286
2025-376K903014
2018-4424K142877
2021-6980K160754
2016-3938K150942
2015-5362K131402
2017-3863FEI 1221826
2022-6690K040383
2022-4906K172044
2026-7776Form FDA 483, FEI 3013944123
2015-9470K884379
2017-3653K092639
2018-3671K050808, K062340
2026-8308Form FDA 483, FEI 3021035729
2026-4915K962613
2023-2062K222476
2022-6135K050574
2015-6003K061640
2015-3705K111303, K111851
2020-4665K190792
2019-1326K180627, K992874
2025-1183EIR, FEI 1000120776
2024-5637Form FDA 483, FEI 3010123206
2023-6264Form FDA 483, FEI 4053
2015-8140K970855
2026-6665K254232
2018-5481K130387
2015-8128K120592
2015-4907K082331
2021-727K003380, K092981, K150286
2023-9178Form FDA 483, FEI 3010860227
2014-8066K140737
2026-5382K241489
2025-12746K012274
2017-5601K142122, K142359
2019-8681K081467
2016-4698K123514
2020-2960FEI 3926
2023-10299K231583
2017-7198K122581
2026-5513Form FDA 483, FEI 1000395711
2023-3715Form FDA 483, FEI 3014498660
2021-1216EIR, FEI 2182208
2024-8758Form FDA 483, FEI 1416980
2023-8501P010047
2017-2352K013481, K122454
2014-8659K121610
2023-5944K904774
2018-1360K121229
2023-9423K203835
2023-7501K223538
2016-2948K152082
2022-5561K063654
2023-2127Form FDA 483, FEI 1282497
2014-8594K060662
2016-3114K023928
2023-4009EIR, FEI 3011053282
2020-5329K143556
2022-872K190292, K201404
2019-6943K180194
2016-6556K160482
2019-6775K002228, K003318
2024-11154Form FDA 483, FEI 3002224346
2021-5985K172875
2020-1064K183575
2025-3907Form FDA 483, FEI 2183715
2022-1082K213028
2018-8970P000005
2024-9862Form FDA 483, FEI 2026940
2022-7390Form FDA 483, FEI 3003166194
2024-8027Form FDA 483, FEI 3003333011
2016-9497K902320
2025-11066FEI 2649711
2017-2945K971320
2024-6134K920501
2017-1393K913749
2022-4585K193067
2024-10635Form FDA 483, FEI 3007617202
2017-4245K060389
2022-8159K060804
2023-6403K190898
2016-6537K040490
2017-4795K070931
2024-3481K231850
2020-8885K042095, K181502, K913098
2023-9117EIR, FEI 1816403
2019-2411K173310
2020-1729K102461
2017-9066K112278
2016-6736K152572
2025-14140Form FDA 483, FEI 3004444888
2022-8678K052424, K123519, K183105
2019-5610K922040
2023-2927K790582
2022-7000Form FDA 483, FEI 1000222289
2022-3163Form FDA 483, FEI 3004452289
2016-10398K062842
2014-7978K103227
2025-12995K010303
2016-8520K150792
2016-10384K000742, K001794
2024-1819K033842
2019-7697K072899, K122011, K122558
2016-7992K151123
2022-1880FEI 3010334444
2021-8244K143114
2015-451K041606
2020-4074K040836
2016-4997K152121, K153555
2017-10045K162042
2021-1722K130873, K143630, K162309
2024-9600Form FDA 483, FEI 1000654629
2018-5400K172783
2018-5768K083641
2025-8947Form FDA 483, FEI 3002806285
2019-5182K101567
2014-10009K112605
2026-6012Form FDA 483, FEI 3042472334
2020-7888K191369
2016-8124K082008
2026-8574Form FDA 483, FEI 3009809074
2021-5575K894224
2017-9104K100415
2020-7668K002740, K072410, K151325
2018-471K063204
2019-96K102867
2025-14325Form FDA 483, FEI 3003338236
2025-836K131773
2020-6599FEI 5906
2018-9099K133961
2025-6942FEI 3002807108
2026-6994Form FDA 483, FEI 3004979815
2017-10027K970685
2017-2091K160949, K162225, K162532
2023-10518Form FDA 483, FEI 1000136478
2015-7961K911398
2024-2008Form FDA 483, FEI 3010221586
2018-1980K043342
2020-5131K200907
2025-8963Form FDA 483, FEI 1819470
2019-11146P120005
2016-3962K110824, K130596
2014-10038P050053
2023-6763Form FDA 483, FEI 3004028690
2024-436K133578, K150538, K172856
2022-6423K172047
2019-3882P050027
2024-1844K171882
2014-8851K050738
2026-4940Form FDA 483, FEI 3014534
2015-8221K093584
2025-14146Form FDA 483, FEI 3012478585
2023-7317FEI 1051786
2018-515K103195
2020-4470K891939
2015-8250K010739, K030379, K041662
2018-8849K180068
2024-3510K012241, K141157, K171699
2022-7309K062466, K071176
2017-3054K140828
2022-5186K072757
2024-3911K221365
2019-6748K004009, K070964, K092264
2015-3395K102350
2020-5113K162253
2020-4579K200136
2017-2092K033337
2019-11500K072160, K123486
2018-7365K172906
2015-8535K942901, K942902, K942903
2017-3202P020056
2016-8599K142252
2022-5699K131635
2015-1376K093642
2015-3747K140828
2026-6717K254232
2023-7788K111577
2020-8884K040316, K123980, K882295
2021-7665P150001, P160017
2017-8603K032821
2016-9187K040390
2016-2165K030719
2022-7657K925197
2019-4359K812769
2022-6341EIR, FEI 3008280916
2017-4843K982616, K994435
2024-2147K192732
2022-3129K160578
2024-1841K090070
2015-434K940208, K945594, K951085
2019-7222K122121, K171620, K172259
2020-3564K152415
2018-123K043555
2015-8277K113658
2025-12909K123990, K160254, K190628
2015-3105K112774
2015-8924K002398
2025-3155K123477, K132652, K150894
2019-464K951595
2025-9480K250524
2023-10451Form FDA 483, FEI 2518422
2022-7134Form FDA 483, FEI 3016603289
2019-11675K061880
2025-13016EIR, FEI 1518939
2026-6227K171392, K192872, K210541
2019-10420K092926
2015-10230K124029
2018-10043K093537
2015-8839K954246
2023-8226Form FDA 483, FEI 3008807866
2018-647K022782
2018-33K061556
2023-3271Form FDA 483, FEI 3009534409
2025-13045Form FDA 483, FEI 1211177
2016-9306K130148
2017-2678K100945
2020-6848K030832
2018-3348K062611
2022-414K202527
2017-1474K150059
2019-3727P100026
2018-4483K130852
2025-11142K140312, K190130, K241364
2023-9510Form FDA 483, FEI 2936485
2020-5768FEI 3000215346
2022-1636Form FDA 483, FEI 3009348684
2024-7108Form FDA 483, FEI 3017517827
2017-7011K162833
2025-2609K041163, K133783, K133829
2022-8147K222166
2021-4305K800666
2016-8536K131796
2024-623K231358
2026-5331Form FDA 483, FEI 3011554160
2026-1232P140003
2026-5409Form FDA 483, FEI 3027058844
2017-4419K000180
2021-5391K042557
2023-9457EIR, FEI 1025114
2015-5037K010265
2019-4646K162748, K173931
2018-1811K121374, K140929
2025-11405Form FDA 483, FEI 3015422154
2015-605K140151
2021-5157K923815
2022-6111P200010
2016-9544K882174
2017-3146K161693
2020-7239K002577, K071341, K101092
2016-9280K160520
2019-1239K182075
2020-5059K162676
2020-6347K002329, K012277, K031463
2026-9251Form FDA 483, FEI 1833310
2019-2822K021100
2023-10204Form FDA 483, FEI 3015399803
2020-2574K052003, K052025, K092560
2023-5774Form FDA 483, FEI 3006024395
2019-6214K101920
2023-2947EIR, FEI 3003166194
2023-44K193070
2023-7977K200828
2016-9259K042961
2015-5068K813324
2023-2231P150017, P150017S005
2023-7892FEI 2431014
2022-8453Form FDA 483, FEI 3007728094
2025-1130Form FDA 483, FEI 2020372
2020-7785K160401
2018-863K132646
2022-8802K192872
2023-3873Form FDA 483, FEI 1025121
2017-954K162128
2022-5381K932122, K944319, K991473
2024-8018K221249
2023-2341Form FDA 483, FEI 2250051
2016-8350K051992
2019-8948K173682
2015-7396K100591
2017-2752K082982
2026-9058Form FDA 483, FEI 3014485094
2020-1671K030612, K071790, K946088
2016-10565K803311
2025-13161K936308
2015-6024K131482
2015-2030K092086
2025-12869Form FDA 483, FEI 3011849720
2017-3871K120161
2026-9380FEI 1220908
2025-995Form FDA 483, FEI 3002808145
2015-87K002154
2024-3687FEI 3002808845
2016-5993K161421
2020-2974K182749
2021-6314K200755
2020-8919K954140
2026-7651K211091, K260647
2020-6250K192154
2018-7184K152635
2019-6359K913098, K972496
2026-7843Form FDA 483, FEI 3009770872
2024-10097Form FDA 483, FEI 3005468265
2023-7409Form FDA 483, FEI 3004882774
2022-303FEI 3003630373
2024-7985K113862, K121319
2018-7204K050094
2023-10784Form FDA 483, FEI 3006634485
2015-4430P010032
2018-4152K162078
2026-5220Form FDA 483, FEI 3009241253
2018-2985K150771, K170818
2026-1929Form FDA 483, FEI 1720734
2015-493K140719
2025-12189FEI 3016575387
2025-11402Form FDA 483, FEI 1000488948
2021-8687K202264
2025-14202K240929
2021-3813K951739
2021-5254K160031
2026-9370Form FDA 483, FEI 3008642652
2026-5299EIR, FEI 3010892830
2016-709K964970
2018-2278K171120
2025-12664K081506
2025-4598K242706
2021-5022K093065
2023-8878EIR, FEI 1000340866
2022-7022Form FDA 483, FEI 3006135941
2021-3359K162999
2025-8109Form FDA 483, FEI 3001677091
2023-1983Form FDA 483, FEI 2025648
2020-4610K170527
2014-8161K843146
2016-9276P100042
2023-1218K103720, K160136, K182456
2019-8481K941558
2018-7713K173090
2026-5257Form FDA 483, FEI 2020372
2018-2429K163328
2015-8537K022006, K111717
2015-5451K143014
2025-10522FEI 3015460945
2019-8656K990660
2017-610K143267
2022-7515Form FDA 483, FEI 3015614180
2016-8677K111933
2022-523K153473
2016-4700K141294
2026-7976Form FDA 483, FEI 1000136230
2022-2229FEI 3002806285
2022-3053Form FDA 483, FEI 3003857817
2017-8281K011251, K121754, K132655
2025-3652Form FDA 483, FEI 3010085632
2018-9590P820063
2024-8788K073423, K081311, K100451
2015-6147K141049
2022-6262FEI 2124914
2020-3087K162131
2023-6792Form FDA 483, FEI 3009888740
2018-8782K905232, K920844, K922368
2023-4490Form FDA 483, FEI 1000121696
2025-12780K100631, K230364
2018-7037K131493
2024-11216Form FDA 483, FEI 3003828812
2017-7718K003583
2016-1720FEI 1722214
2026-5142Form FDA 483, FEI 3000215335
2014-9054K141522
2022-7783FEI 1220423
2026-6782Form FDA 483, FEI 1000119582
2019-6820K041929, K092405
2019-5089K060169
2015-3608K112595
2016-2062K140279
2025-12379FEI 2936532
2015-5615K063873
2018-6135P160007
2024-4812K991972
2025-3444Form FDA 483, FEI 1513988
2016-3234K964034
2023-398K921872
2016-2720P020014
2018-5186K172258
2025-8461Form FDA 483, FEI 1000123308
2021-4922K202072
2024-7764Form FDA 483, FEI 3008500974
2017-4044K163378
2018-182K151476
2026-6873Form FDA 483, FEI 3004112148
2018-6993K162572
2015-5492K011536
2016-7311K141580, K141698
2020-458K152602
2024-2910K152077
2022-1779K200422, K200667
2024-3558K230857, K240720
2023-250K170982
2019-3269K003335, K053476, K081415
2019-5243K172701
2020-4512K193319
2024-11287Form FDA 483, FEI 3014607865
2016-5546K153698
2018-4776K180265
2014-8256K071468
2020-2486K180111
2022-5342K133593
2015-9558K971358
2023-2370K142870
2022-2330K061711
2024-708Form FDA 483, FEI 2026940
2025-11416Form FDA 483, FEI 3008855505
2024-4855K971664, K972452
2018-6948K141770
2018-4863K160836
2025-2582K242473
2022-2588K182964
2024-327K063295, K231045
2026-8804Form FDA 483, FEI 3019807891
2022-3808FEI 1000513101
2016-9714K152894, K161459, K161966
2015-8675Form FDA 483
2019-2976K173574
2024-3483K803293, K953776, K973827
2020-1987K041331, K061374, K082438
2025-2231Form FDA 483, FEI 3003708554
2025-3936Form FDA 483, FEI 2244725
2025-8481K202157
2023-1560K150880
2016-282K090626, K121579
2026-5300Form FDA 483, FEI 3009134706
2025-13825Form FDA 483, FEI 2220100
2018-717K132987
2026-9367Form FDA 483, FEI 3003793491
2020-8784K190273, K202306
2016-8775K103227
2024-5043K183865
2016-2187K152421
2025-8788Form FDA 483, FEI 3010427901
2018-3972K030837
2016-7628K925624
2014-9544K122129
2019-4620K181472
2026-7328Form FDA 483, FEI 3022175264
2026-6048Form FDA 483, FEI 3012806810
2019-3218K050918
2018-9584P820056
2026-7887Form FDA 483, FEI 3002827704
2024-1946Form FDA 483, FEI 3020869111
2021-3518K189943
2016-3919K121190
2025-3806K213955
2024-4583K021791, K030736, K041197
2024-1026K200947
2021-6323FEI 3425
2018-3116P020014
2017-5227K082426
2024-138Form FDA 483, FEI 3002806457
2019-9521K173510
2014-9940K010336
2020-6940K172796
2025-9173P820012
2023-11186Form FDA 483, FEI 1831301
2022-7520K001401, K183635, K211678
2016-720K073122
2016-8714K130354
2023-2985K000442
2024-2436K900547
2016-6749K131895
2015-3245K073630
2015-8040K042002, K042463, K930564
2018-5536K033660
2015-819K974187
2017-8659K972375, K972376
2020-7491K831678
2016-10584K160433
2018-9757K150711
2026-5322K893480
2017-6296K162470
2018-8541K181863
2016-3168K041331
2026-5212Form FDA 483, FEI 3003338236
2019-2781K180850
2022-873K203768, K203772, K203774
2015-5939K904950
2015-234K141399
2023-9182Form FDA 483, FEI 3005515469
2015-9255K083822
2023-4701K213833
2014-9179K070561, K103412
2022-6671FEI 3002315840
2024-1772K223620
2015-7752K123910
2025-638Form FDA 483, FEI 1000159898
2025-3312K053055
2017-751K072505
2018-6384K030861
2015-5740K002063, K140249
2016-8437K020114, K143242, K160342
2024-9434K020808
2025-14336K252392
2016-3935K081389
2020-6735Form FDA 483, FEI 3001883144
2022-8165Form FDA 483, FEI 3000204446
2021-6935Form FDA 483, FEI 3007772056
2023-1151K221479
2017-1922K921415
2015-1439K070375
2018-6171K030281
2020-2102FEI 3005083505
2015-594P050027
2016-9700K051242, K160755
2015-9808K130793
2015-8358K001447, K022086
2015-2270K874656, K932199, K941870
2022-4546K190610, K201806, K202554
2015-9059K926139
2017-4738K170784
2026-6055Form FDA 483, FEI 3009384112
2023-773K213087
2022-1079K111738, K213631
2023-10503K230775
2016-3176K103233
2015-3570K053025
2015-10057K042076
2018-9524K141922
2025-1760Form FDA 483, FEI 3004073926
2016-7999K090095, K091160, K093423
2023-5810Form FDA 483, FEI 1000120916
2024-7860K234114
2023-11536Form FDA 483, FEI 3003800209
2019-7922K160770
2015-5906K002138
2014-8314K844918
2025-2156EIR, FEI 3007772056
2023-3444Form FDA 483, FEI 1221539
2018-652K020537
2024-10157Form FDA 483, FEI 1319086
2019-8984K142432, K152178, K171366
2022-1398K173739
2017-1612K111495
2015-8091K043193
2022-7762Form FDA 483, FEI 3005670760
2021-8340K142491
2022-1436K100055, K100763, K101123
2021-8771K163296, K173632
2019-7719K030685, K050159, K112679
2019-9723K160493
2025-3627K972496
2023-7702Form FDA 483, FEI 1049754
2023-2733K092219, K151901, K172007
2022-4984K023984
2021-8443K872048
2017-642K160968
2019-6753K020311, K041283, K062340
2018-1806K101764, K932571
2020-4449K192063, P170019, P190014
2023-2167Form FDA 483, FEI 3017168767
2016-3473K150841
2025-3209Form FDA 483, FEI 3005669319
2026-5141Form FDA 483, FEI 3010396502
2017-1253K954798
2018-2828K900516
2019-9594K000580, K051681, K131287
2017-6335K122953
2017-5793K093489
2019-8701K152014
2016-7321K132785
2026-9167FEI 1220908
2016-8584K071845
2016-809K884309
2022-446K163512
2019-10196K153049
2020-7790K191272
2017-10451K011369
2018-4169K152948
2026-5514Form FDA 483, FEI 1000548922
2015-4653K142672
2024-4048K233737
2020-3012K152754
2017-4838K061780
2021-2705K930669
2019-6826K011488, K121064, K142603
2017-2394K091186
2025-326K160333
2016-5240K141620
2015-6821K862022
2015-9915K143263
2020-3961K163622
2018-3316K950270
2017-1199K954530
2024-5783Form FDA 483, FEI 3008787503
2023-9839K130191, K192423, K220549
2025-1455Form FDA 483, FEI 3008361680
2022-6194K181612
2018-1582K173587
2017-5905K990284
2019-3265K010265, K102859, K813324
2022-5550Form FDA 483, FEI 3003595343
2025-14320Form FDA 483, FEI 3007886583
2014-8804K140378
2020-3962K131234
2025-3863Form FDA 483, FEI 3008321254
2026-8882Form FDA 483, FEI 1922337
2024-225Form FDA 483, FEI 3001744192
2015-1869K123653
2023-9250FEI 3004785273
2020-1429K031373
2022-106K143094
2021-253K200608, K201607
2020-5692K191332
2023-5442Form FDA 483, FEI 3013934051
2024-10477K033801, K103433, K163046
2019-9541K150869
2018-8499K181771
2017-1641K141833
2026-7347P960020, P990002
2015-1085K060463
2016-8443K111254
2023-5921K093923
2017-5098K031373, K122953, K160252
2014-9974K033374
2026-8572K243515
2021-3152K070351
2024-1964FEI 1219738
2025-176Form FDA 483, FEI 3012265577
2023-6203Form FDA 483, FEI 1043646
2025-14167Form FDA 483, FEI 3021570645
2024-7405Form FDA 483, FEI 3007208829
2016-6873K073088
2018-3762K151168
2023-3038FEI 3274
2019-2701K153611
2019-10429K941258
2016-10611K133742
2020-2298K020537
2017-1370K060812, K063377
2025-3582Form FDA 483, FEI 3007237389
2024-4534Form FDA 483, FEI 3025488663
2015-3225K994010
2017-339K992760
2015-5251K101990
2015-5248K141122
2023-9800Form FDA 483, FEI 3010622588
2017-8734K163407
2022-5543Form FDA 483, FEI 3009659896
2023-3267Form FDA 483, FEI 3011099779
2023-1462FEI 1410248
2017-3438K170456
2017-8201K071538
2021-4917Form FDA 483, FEI 3007772056
2020-1428K182581
2023-8192FEI 3005880844
2019-6222K140501
2025-8905Form FDA 483, FEI 3002806503
2015-6506K972217, K972219
2017-3949K061204, K920844, K974285
2022-5564K010817, K022077, K112791
2025-14326Form FDA 483, FEI 3024508819
2018-3103K091283
2017-1348K901659
2014-9535K142303
2025-14184K210693
2018-346K170216, K170415, K170814
2014-9449K840613, K863539, K893531
2025-3855Form FDA 483, FEI 3010052743
2016-7061K151482
2021-4017K171011
2019-2722K093520, K153283, K180162
2019-10537K172166
2024-6116K123803, K173841, K191680
2017-8576K012868
2026-6043Form FDA 483, FEI 1011574
2023-7826K160176
2022-7666K211785
2025-1705K241488
2023-10083P160031
2024-304Form FDA 483, FEI 3010155661
2021-8058P040021
2021-7414FEI 3007772056
2016-4644K121221
2023-1567EIR, FEI 3000209995
2025-1500Form FDA 483, FEI 3015907115
2022-8197K110424, K173730, K203641
2016-8855P840002
2025-1928K034065
2025-13105K191556
2022-8585K191614
2025-9052FEI 9673241
2022-2028K081467
2018-10187K063148
2024-2315Form FDA 483
2019-10960K190792
2026-1261K092342, K250493
2015-550K130010
2019-9274K153729
2018-3411K132671
2016-9174K111622
2023-504Form FDA 483, FEI 1819174
2022-4807Form FDA 483, FEI 3013014383
2024-10085FEI 3010060216
2021-2011K101428
2022-3504K143120
2015-5099K003154
2020-6733Form FDA 483, FEI 3011270181
2017-6696K133916
2023-6638K052767
2018-6255K171810
2023-2925K192875
2022-7523Form FDA 483, FEI 3004146605
2023-8176Form FDA 483, FEI 3015549533
2026-1868Form FDA 483, FEI 3030438338
2017-5682K162050
2021-7524K033960
2023-3382Form FDA 483, FEI 3006111110
2018-6686K043509
2021-7439K161112, K162248, K162524
2023-1023Form FDA 483, FEI 3017419219

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