Data catalog

FDA FOIA requests

About 15K records

More records

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

2015-847K133573
2025-3166Form FDA 483, FEI 3009389940
2021-4495K191401
2021-8510K992664
2016-10612K032526
2025-12596K161043
2019-8796K183205
2022-1128FEI 3009109670
2018-799K915859
2021-3571K050369, K180033
2022-4397Form FDA 483, FEI 3007772056
2019-7213K163279
2017-5903K123213, K131549, K141448
2023-5551Form FDA 483, FEI 3005949964
2015-2946K123468
2025-11929FEI 3007829657
2015-7736K983210
2022-5032K972699
2018-5528K040372
2025-10655K093362, K123835
2015-9006K150638
2021-7167FEI 1717046
2025-7211K904943
2021-729K081410, K100261, K143405
2022-5435K160433
2024-10613Form FDA 483, FEI 3004380247
2025-10559K862875
2025-12580Form FDA 483, FEI 1419377
2025-8639K050753
2024-4245K233199
2026-5159Form FDA 483, FEI 3003347293
2022-1458K163221, K171651, K191100
2026-5174Form FDA 483, FEI 3017140511
2015-1513K131146, K942530
2014-8201K990328
2015-6010K141119
2025-1289Form FDA 483, FEI 1220423
2018-5210K172236
2015-175P920023
2025-4159FEI 5864
2016-3275K013623, K030883, K072331
2023-1736Form FDA 483, FEI 1025121
2025-4073Form FDA 483, FEI 3004541594
2019-7691K190428, P160019
2020-7741K050525
2020-8606FEI 7695
2016-3441K143752
2018-5032K073090
2019-773K062672, K071178, K103595
2018-34K031759
2024-1553K213536
2018-110K070475, K091405, K103088
2025-7055Form FDA 483, FEI 3006851654
2025-797Form FDA 483, FEI 1045125
2023-4618FEI 3021769057
2018-476K162762
2022-4808Form FDA 483, FEI 3005874880
2025-14082K220122
2020-2358K051647
2021-6638K874752
2015-5405K102217
2018-6474K123486
2019-11928K072932
2026-5772Form FDA 483, FEI 3013411964
2016-7834P030056
2018-8874K172114
2017-10145K101314
2015-8867K002533
2018-7672K032922
2024-6420K182711
2017-9628K162640
2019-1624K163255
2016-8748K160752
2026-4993Form FDA 483, FEI 3001677091
2020-3529K152404
2016-9769K003901
2023-9491Form FDA 483, FEI 3010145797
2020-1570K123904
2019-7237K080670, K112489, K142303
2022-6692K001277
2024-3818EIR, FEI 3013667284
2016-8554K093138
2026-9106K010338
2023-9068K925914
2025-14293Form FDA 483, FEI 1019820
2026-5360Form FDA 483, FEI 1181055
2025-2418K060937
2016-9314K070910
2024-5698Form FDA 483, FEI 3004507660
2023-3261Form FDA 483, FEI 1221645
2024-5764Form FDA 483, FEI 3003770530
2017-8234K163271
2019-6668Form FDA 483
2017-9830K033590, K060183
2021-7442FEI 3002626007
2016-8215K041604
2026-5007Form FDA 483, FEI 3005779557
2024-10623FEI 3009234552
2023-10686Form FDA 483, FEI 3010642815
2021-4376K132920
2017-9102K130164
2023-8709K124018
2024-6989Form FDA 483, FEI 4498
2024-9961K093027
2019-6205K122436
2023-5788EIR, FEI 3006258094
2023-2225Form FDA 483, FEI 3003573572
2017-7331K161672
2023-5341K222001
2023-11524K221301
2016-3583K103106
2019-4141K030086, K033382, K033563
2018-10221K061851
2024-8200K201072
2016-7069K020435
2023-4249Form FDA 483, FEI 3008747271
2022-3146FEI 3004167969
2021-1160K053610
2026-7858FEI 3017254114
2024-9158K211291
2025-12188FEI 1000120548
2019-4270K112568, K131345, K844504
2019-9205K073484
2015-5074K122048
2024-8648K200299
2023-8700K140211, K915075
2023-660K220951
2018-6134K150522
2018-7750K050702
2022-513K211526
2018-6274K172460
2017-2918K052692
2016-2739K150089
2018-1005K153660, K162309
2016-9205K080931
2025-3770Form FDA 483, FEI 3014585508
2020-3553K962649
2024-8586EIR, FEI 1000654629
2023-8254Form FDA 483, FEI 1928237
2015-8213K150754
2018-8459K151199
2022-456K143484, K152070, K171467
2023-1873K103561
2016-656K061996
2019-10987K182296
2026-6895K181324
2022-7756Form FDA 483, FEI 3013441423
2024-9063K031649
2022-2032K162193
2022-7653K221047
2015-9807K140255
2026-7585Form FDA 483, FEI 3007165178
2016-2210K102581
2016-9767K151149
2023-11077Form FDA 483, FEI 1130591
2022-4718FEI 2518422
2016-9521K152379
2018-6411K090993
2025-12064Form FDA 483, FEI 3003428492
2016-404K123696
2021-4192Form FDA 483, FEI 3006619220
2017-1721K083802
2015-3849K944692
2023-2148Form FDA 483, FEI 3009751352
2017-48K160006
2017-1457K093708
2020-8318K200678
2022-4321K212955
2023-11550Form FDA 483, FEI 3007536957
2016-5297K143551
2015-3563K100049
2021-317K181751
2016-9957K093821
2021-1973K150083
2016-10K982946
2020-164K170005
2020-7786K181612
2026-5137Form FDA 483, FEI 3001049282
2026-5095Form FDA 483, FEI 2244725
2026-8749K242557
2016-4892K121597
2026-8040Form FDA 483, FEI 3003347293
2025-8883K241612
2024-7229Form FDA 483, FEI 3007208829
2024-3150Form FDA 483, FEI 3002805559
2018-3555K932364, K932366, K932368
2023-9065Form FDA 483, FEI 1314417
2022-7267Form FDA 483, FEI 3012470925
2024-9217Form FDA 483, FEI 1000526882
2017-10693K934086
2017-9767K103547
2017-9797K060040, K071856, K081007
2015-7662K940852
2016-1105K011812
2021-2310K050156
2016-9294K080964, K994267
2023-2962Form FDA 483, FEI 1037137
2024-8006K241684
2016-7029K160644
2023-6829FEI 3010331645
2023-7793FEI 3014732
2018-5035K172191
2015-4528K061243
2024-16Form FDA 483, FEI 1511629
2019-10146Form FDA 483
2025-8851K160764
2024-8149K030737, K233985
2014-9700K062163
2023-10588K220606, K223299
2017-7932K905685
2017-9014K844630
2015-9846K982946
2018-17K130665
2025-14357P970010
2021-4957K160764
2017-130K080403
2022-4320K212773
2024-4955EIR, FEI 3006126537
2021-5234K071168
2025-138K212815
2020-2477K173780
2018-4318K173692
2025-4498Form FDA 483, FEI 1937990
2016-2109K130852
2020-1722K010817
2023-1965K183078
2023-3854FEI 3008662397
2016-7382Form FDA 483, FEI 4838
2016-8670K142743
2022-7969FEI 6423
2018-8779K172410, K172800, K172823
2022-7784K151904
2020-5497K151620
2020-8663K200803
2020-7979K150835
2022-6137K181043
2023-2337Form FDA 483, FEI 3015967359
2023-1914K131861
2017-9339K170300
2019-3296P120022
2026-1580Form FDA 483, FEI 3013666336
2015-4505K950566, K953645, K983068
2021-3391K062061
2016-5959K011025, K120897, K851086
2022-3442K161777
2026-5837Form FDA 483, FEI 3022977716
2019-5052K133243
2018-3413K841762
2018-6165P840029
2022-8646K201188, K201898
2022-1638Form FDA 483, FEI 3007363461
2015-9640K812893
2017-7946K060832
2025-10191FEI 1000121696
2019-10961K150869
2023-5183K150095
2014-9244K101641
2024-1710Form FDA 483, FEI 3015549533
2018-7900K090139, K123347, K141735
2017-6508K170195
2025-2561Form FDA 483, FEI 2450054
2019-11541K160806, K161354, K182768
2020-2928K190332
2026-8470Form FDA 483, FEI 3011913386
2022-3286K163232, K190764
2026-8038K211333
2017-8544K082556, K143630, K163689
2025-10069FEI 1220423
2019-3481K062042, K841202, K941781
2017-128K134005
2017-10345K926508
2024-6650EIR, FEI 3001155023
2020-1368K142870
2023-8052K213815, K812564, K942543
2022-8550Form FDA 483, FEI 3012327767
2015-5441P010032
2025-11816Form FDA 483, FEI 3012160128
2020-8211K050456, K143372, K162572
2021-3563K161355
2024-7105Form FDA 483, FEI 3021769057
2025-3676K152319
2023-3374Form FDA 483, FEI 3001237319
2017-2326K014241
2023-940K172381
2016-10103K031024, K040723, K982995
2023-8724FEI 3007134923
2016-10301K152163
2014-9424K042970
2015-9134K010292, K022602, K023160
2021-3436K080863
2017-90K160112
2018-971K172021
2017-9163K161332
2015-4163K033437
2025-7776Form FDA 483, FEI 3002806285
2026-7583Form FDA 483, FEI 3044182936
2025-835K160743
2026-8268Form FDA 483, FEI 3001286223
2017-9K062779
2025-12028Form FDA 483, FEI 3002889431
2017-10743K982532
2016-7769K160420
2018-9957K143380
2016-4671K910007
2023-7624FEI 3006182775
2026-7859Form FDA 483, FEI 3017254114
2019-11933K103332
2019-4666K920015, K950305
2021-8647K170565
2016-7611K040491, K071560, K102404
2023-6660Form FDA 483, FEI 1043551
2021-3672K153502
2015-1832K142787
2025-10745K823836
2021-7637K874428, K895561, K895562
2021-2472K163069
2016-3415K151763
2023-4377Form FDA 483, FEI 3008069988
2015-485K924436
2015-6325K123141
2023-2325K162579
2024-5867Form FDA 483, FEI 1216677
2023-7516Form FDA 483, FEI 1010370
2024-9153K192958
2024-7060Form FDA 483, FEI 3007208829
2023-5582Form FDA 483, FEI 3005949964
2017-7896K170272
2019-10090K171186
2022-4920K031799
2015-6634K143219
2024-6380K941439
2017-5680K133212
2017-2470K153618
2015-7264K061050, K100280, K963872
2017-2245K151159
2026-1966K231325
2015-10204K982256
2018-770K171534
2018-2205K162050
2017-10021K130651, P920023
2016-6594K152061
2024-8319Form FDA 483, FEI 1000635022
2025-3066K220628
2018-6617K021904
2017-6974K163062
2020-7150K081126
2024-714K223290
2025-1797K241197
2019-2565P090015
2023-4654EIR, FEI 3008396914
2025-9630Form FDA 483, FEI 1038833
2021-449K191990
2026-4698Form FDA 483, FEI 3010140265
2016-10581K113215
2023-2931K221614
2016-6639K010727
2021-8833Form FDA 483, FEI 3003166194
2014-8555K132983
2016-5769K970074
2015-5704P010030
2016-4845P000028
2015-7975K024060
2024-9885K072427
2015-9093K031036, K032671
2016-2682K110516
2021-5024K163357
2023-9464Form FDA 483, FEI 3005488132
2022-7028Form FDA 483, FEI 3008590411
2022-8905K150160
2025-12910K243387
2019-10256K133884, K150571
2018-1358K140866
2026-4422Form FDA 483, FEI 3006261638
2022-6261FEI 3008769756
2022-6683K180403
2023-5118Form FDA 483, FEI 3002718545
2025-10514Form FDA 483, FEI 5754
2025-10380K233225
2022-4818Form FDA 483, FEI 3009976527
2017-10545K163484
2025-4022K250555
2022-3032Form FDA 483, FEI 3015255331
2019-1868K091217, K103784, K173188
2026-6511Form FDA 483, FEI 3014222368
2026-9180Form FDA 483, FEI 3006385287
2024-7521Form FDA 483, FEI 1220423
2022-3974K071937, K170672, K173577
2019-11820K150878
2018-1465K160229, K171956
2017-4740K021144, K850342, K964224
2018-3735K171356
2024-6112K163548, K171589, K180403
2015-2725K132182
2023-4507K112423, K141932, K190610
2021-539K072757
2020-17K113536
2017-9177K162205
2024-2149FEI 3012266277
2026-7654Form FDA 483, FEI 3041244757
2020-3142K140190, K153293, K162078
2026-5061Form FDA 483, FEI 3009598981
2022-6628K103720
2021-2419P170023
2018-8658K172039
2023-7411Form FDA 483, FEI 3009319607
2021-593K033962
2023-3712Form FDA 483, FEI 3003166194
2023-3540K072002, K083093, K101123
2016-2675K151763
2022-4357K140023
2024-6580K211786
2022-2492K920977
2019-8594K031373, K071220, K091996
2021-546K180466
2015-2935K133705
2023-8053Form FDA 483
2026-9066Form FDA 483, FEI 3013337852
2018-7951K163232
2020-8075Form FDA 483, FEI 2020394
2015-9826K151525
2024-4973Form FDA 483, FEI 1454831
2022-3612K171771
2023-7512Form FDA 483, FEI 3008312728
2025-3224Form FDA 483, FEI 3014585508
2020-5937K173974
2023-8522P060040
2024-9255K193371
2024-4309Form FDA 483, FEI 2246948
2015-5569K930622
2025-4545Form FDA 483, FEI 3012341472
2016-9897K160511, K161266
2025-7920Form FDA 483, FEI 3009336980
2023-5763FEI 3004661493
2016-4640K032163
2018-7712K971640
2019-11824K172258
2016-3080K123265
2017-5130K140780
2024-6423K161090
2016-6311K110661
2015-6717K030684
2017-753K141581
2026-8265EIR, FEI 1317202
2018-442K120412
2023-7504Form FDA 483, FEI 3008492433
2023-10656K220140
2015-3268K102915, K111862
2020-8485Form FDA 483, FEI 1000513101
2025-2685K100261
2018-4341K163328
2019-11072K102461, K122172, K130281
2019-3266K070423, K092503, K111837
2025-12502FEI 3006999111
2026-4429Form FDA 483, FEI 1219540
2018-4477K053342, K063158
2020-5225K152550
2016-9197K080838
2016-6286K112098
2022-5834Form FDA 483, FEI 3007772056
2026-7002K253992
2019-2402K181859
2016-4135K143482
2018-9591P820063
2017-9168K993951
2020-2470K200228
2026-7806K182274
2020-7101K993319
2023-5708FEI 3004450973
2019-10249K173452
2015-9713K944117
2015-9472K993021
2016-2049K041502, K150041
2016-705K143513
2022-1085K993582
2024-2925K090855
2015-8323P890003
2025-442EIR, FEI 3008599177
2025-1049Form FDA 483, FEI 3014171792
2018-5907K160862
2019-3534FEI 1219343
2016-475K131286
2023-5350K212871
2022-6538Form FDA 483, FEI 3015937270
2021-3297K161447
2025-7672K945118
2020-8002K162941
2024-5009Form FDA 483, FEI 3003897287
2026-5047Form FDA 483, FEI 1710034
2019-6217K052322
2026-7787K934445, K954340
2019-5685K073326, K122926, K150709
2022-2589K063217
2025-9189Form FDA 483, FEI 3004035727
2022-4194FEI 3006260740
2016-536K112628
2019-10204K191503, K191645
2021-5694Form FDA 483, FEI 1000306051
2016-10428K863547
2023-3059Form FDA 483, FEI 3009751352
2024-10892K970639
2015-1871K143155
2023-5976Form FDA 483, FEI 3003200197
2024-8637Form FDA 483, FEI 1811396
2022-4166K092219
2026-5700K250298, K981260
2016-5813K152384
2022-8301K903163
2023-7325Form FDA 483, FEI 3000215342
2025-1070K220411
2026-9396FEI 1218058
2024-8803K192930
2021-6761K061079
2019-7537Form FDA 483
2024-3218K131861
2022-8803K210541
2024-7631K163001
2016-8722K160770
2015-5151K900295
2024-4994K171658
2026-7458Form FDA 483, FEI 3008514029
2019-7686P160030
2025-9488Form FDA 483, FEI 1000221028
2023-8281K221241
2022-5544Form FDA 483, FEI 3007712511
2021-5859Form FDA 483, FEI 3014074925
2015-7362K142779
2020-8610K033488, K123710, K190230
2014-9744K031168
2017-4231K110332
2025-13394Form FDA 483, FEI 3023251262
2019-10706K181603, K182182
2025-12638Form FDA 483, FEI 3002807393
2020-4556K002705
2018-2704K162309
2019-7872K142649, K143314, K150783
2025-10184FEI 3025620599
2019-2044K130626
2022-5937K192155
2018-8082K180690
2018-2740K860467
2015-1004K081406
2023-7819P200021
2023-8491K050843, K072683
2015-9697K102439
2022-3279K882980
2023-6288Form FDA 483, FEI 3004558433
2025-3906Form FDA 483, FEI 1930126
2016-8135K032123
2021-7987K213163
2023-7440K070136
2025-8719K792712
2025-10340FEI 2020372
2023-7579K173718
2020-6545K071562, K160538
2016-5311K983045
2018-591K013093
2022-4867Form FDA 483, FEI 3015614180
2021-6321K192385
2021-6025K200242
2025-8889Form FDA 483, FEI 3008414621
2019-10912K192194
2022-6954Form FDA 483, FEI 3013649990
2024-3283K181451
2026-1270Form FDA 483, FEI 2021236
2021-4339K132671, K153407
2018-548P000005
2019-713K820280, K820492, K827123
2021-1872K202045
2022-8716FEI 1316297
2019-4303K060055
2016-9202K110203
2018-6527K143615
2023-11418Form FDA 483, FEI 3009809074
2014-9422K121964
2016-496K131345
2016-1966K140933
2019-8276K050016, K130126, K131559
2025-13401K242735
2023-9067K220635
2021-8339K160764
2019-9083K072410
2018-9581P820056
2020-5000EIR, FEI 3010079947
2023-5361K062466, K071176, K072757
2023-915Form FDA 483, FEI 2243057
2016-1820K122494
2016-2543K142969
2024-5459Form FDA 483, FEI 3006435903
2024-5642Form FDA 483, FEI 3010089756
2025-2499Form FDA 483, FEI 3009234552
2019-7967P160048
2026-1368FEI 3007134923
2019-8776K971849
2023-10480Form FDA 483, FEI 3002995416
2021-603P110042
2019-4026K183078
2016-8864K161289
2016-1013Form FDA 483, FEI 5468
2020-7076K002699
2023-5236Form FDA 483, FEI 3001451660
2022-6953Form FDA 483, FEI 3006315274
2019-10313K150067
2023-1280Form FDA 483, FEI 7759
2017-153K161266
2017-8277K001122, K962530, K974098
2024-2804K002837
2015-10206K053476
2024-3852K100451
2018-3985K171069
2023-9218Form FDA 483, FEI 3003156974
2018-2342P160007
2023-10994Form FDA 483, FEI 3005543241
2019-7722K053106, K102599, K112997
2025-13236Form FDA 483, FEI 3021902344
2026-6771Form FDA 483, FEI 3035111095
2021-8820FEI 3003320928
2015-9235K130996
2024-4008K230701
2025-12320FEI 3011625895
2018-4380K041995
2023-4585K130498
2016-7545K142316
2022-5592FEI 3012144557
2018-8027K151511
2020-4200K050094, K122149, K133382
2020-4177K150729
2025-3873Form FDA 483, FEI 1045125
2019-9111K122219, K141434, K142915
2016-3680K140131
2024-3765FEI 3006974616
2018-4444K090801
2016-5694K053645
2019-5251P100018
2021-2432K151909, K153064, K183069
2016-1416K140638
2022-4504K141932
2025-13802K192389, K233991
2024-6579K230703
2025-1925K964066
2018-9436K180711
2019-1946K173822
2025-7270P030017
2023-401FEI 1721504
2018-5284K172831
2016-9410K110753, K131578, K160825
2016-2293K120792
2024-5842K970102
2016-7435K102973
2016-5943K141421
2025-558Form FDA 483, FEI 3005161223
2014-8587K133725
2019-8680K160474
2015-9547K151525
2023-10733Form FDA 483, FEI 3005755244
2020-3747K192272
2021-4012K162296, K180045, K182630
2023-1392K190764
2025-3358Form FDA 483, FEI 1035166
2017-1923K122619
2023-5714Form FDA 483, FEI 1628114
2022-4695FEI 3004438257
2024-2959K030737, K971329
2020-8677P140026
2016-4473K121434
2026-9275Form FDA 483, FEI 3011292417
2025-11000K131954
2024-10174K002889, K881915, K883340
2022-1516K163484, K170871, K173032
2026-4961Form FDA 483, FEI 3014732157
2015-2258K081593
2016-889K100927
2023-11399Form FDA 483, FEI 2023529
2016-5243K153673
2017-9170K132936
2023-6910Form FDA 483, FEI 1811396
2026-7753Form FDA 483, FEI 1416980
2016-6052K053344
2015-4383K131158
2024-2752K230734
2017-10019K160309
2019-9109K090001, K120552, K132121
2026-6926K160128, K180031
2024-8871Form FDA 483, FEI 1000305755
2023-5045Form FDA 483, FEI 3014833750
2020-2635K030176
2019-2631K140657
2015-7120K010809
2019-10307K120814
2016-11K982256
2017-3860K163306
2023-5227Form FDA 483, FEI 3009690171
2021-3758K971782
2016-3031K141012
2020-5408K171159
2024-10915K203664
2023-4432K222095
2021-2931K203782
2019-11934K133897
2017-1359K143405
2021-1507FEI 1925262
2015-7885K771203
2023-10877K122885
2017-1080K100820
2015-2948K142024
2016-6100K082947
2026-6487FEI 3006010712
2023-8773Form FDA 483, FEI 1416980
2015-9163K052148
2022-3650K190792
2024-3145Form FDA 483, FEI 3002907620
2026-9141K262253
2016-2643K112478
2026-9287FEI 3005779557
2023-4810K203144
2018-1505K101241
2025-3449Form FDA 483, FEI 3014585508
2016-9960K160294, K160295, K160296
2023-2089EIR, FEI 2025292
2023-6993FEI 2242327
2017-863K153678
2024-6394P040020
2026-4823Form FDA 483, FEI 1413475
2019-896K951220, K953405
2024-1258K111628, K134039, K142897
2017-7842K160295, K160297, K170218
2017-2471K063227
2026-7342Form FDA 483, FEI 1821729
2016-6022K092863
2021-4870Form FDA 483, FEI 3002806368
2019-97K172701
2026-6795Form FDA 483, FEI 3017773925
2016-8405P020014
2023-2077Form FDA 483, FEI 1417519
2016-9893K140828
2014-8539K080613
2023-10996Form FDA 483, FEI 3016090213
2024-6845K791899
2023-1847Form FDA 483, FEI 3002998723
2021-3302K141057
2022-1310FEI 2020952
2026-5721K251295
2025-1912Form FDA 483, FEI 1221967
2024-4518Form FDA 483, FEI 3004153240
2022-983K202279
2019-6233K142818
2019-8546K091930
2016-2161P100005
2023-7415Form FDA 483, FEI 3006774448
2018-3027K052567
2018-566K150754
2023-5209K213857
2015-9024K033414
2024-7123Form FDA 483, FEI 3001236277
2020-8675P160001
2015-9052K150685
2017-5552K161509
2015-533K140151
2024-402Form FDA 483, FEI 1526611
2018-2201K160259
2015-3616K000068
2025-14166Form FDA 483, FEI 3010894343
2017-10121K160669
2025-7277Form FDA 483, FEI 3024852742
2023-5109K193371, K201761, K210943
2020-6685K922949
2023-2959Form FDA 483, FEI 3003524171
2014-9938K123459
2022-1346FEI 3003010579
2025-1593Form FDA 483, FEI 3004217743
2019-8746K170294
2024-4500K202208, K230645
2023-7745K170981, K192051
2026-8487Form FDA 483, FEI 3021619527
2023-6002Form FDA 483, FEI 1220246
2022-1134Form FDA 483, FEI 2518422
2020-5042K150729
2021-6110K033688
2023-3127Form FDA 483, FEI 1922337
2020-2233Form FDA 483
2015-1899K110134
2020-1536K151525
2015-8894K111904
2017-4914K103302, K113566
2023-8188FEI 2523865
2025-1457Form FDA 483, FEI 3002757549
2017-1477K131383
2020-1338P960040
2026-5913Form FDA 483, FEI 1000160007
2019-1775K062074, K083271, K122467
2023-6965K112605
2015-9457K093677
2023-2591Form FDA 483, FEI 1000122243
2020-4581P773147, P970051
2025-7747K241169
2017-1241K100765, K113324
2022-8929K191103
2019-7102K190896
2022-8237K203774
2016-7644K062321, K102541, K123407
2015-5129K132649
2025-4434K903771
2025-832K033326
2025-8604Form FDA 483, FEI 3002807393
2026-9392FEI 1218058
2017-7665K140151
2022-4273K193009
2022-6672FEI 3002942387
2018-582K133532
2024-3913Form FDA 483, FEI 1000517638
2023-8864Form FDA 483, FEI 2013558
2026-9061Form FDA 483, FEI 2246315
2019-1951K173879
2014-8873K133718
2026-8133Form FDA 483, FEI 3012262584
2016-9044K090170
2017-4372K072618, K120242, K162467
2026-6455Form FDA 483, FEI 1317511
2020-4131Form FDA 483, FEI 1045125
2021-383K060764, K083208, K141434
2016-9640K900138
2023-5936Form FDA 483, FEI 1000114355
2021-4573K182384
2017-555K081232
2025-8850K142491
2021-1583P130022
2015-9151K971467
2026-6981K983743
2025-3646Form FDA 483, FEI 1000110937
2025-6964K102529
2018-9633K912702
2015-4854Form FDA 483, FEI 2922
2022-8196K051814, K072539, K080881
2025-3891Form FDA 483, FEI 3009538923
2019-3719K940973
2026-7945EIR, FEI 2939693
2025-1485Form FDA 483, FEI 1221084
2019-6765K190360
2021-3184K103411, K160493, K170867
2018-8305K000685
2016-2618K152060
2020-4518K111354
2018-9270K073495
2022-7276K092746
2022-954K141617, K163549, K172695
2022-7150K191804
2024-3352K091018
2022-6727K980056
2026-9119Form FDA 483, FEI 1220908
2021-7986K001277
2017-1219K940120
2015-8771K872810, K902921, K904514
2019-1049FEI 6433
2025-11849Form FDA 483, FEI 3010047402
2025-13343Form FDA 483, FEI 3014174860
2026-7847Form FDA 483, FEI 3009129782
2022-7815K022023
2025-7383K213424
2021-4409EIR, FEI 2183620
2023-1393K850431
2015-7596K112478
2023-3320Form FDA 483, FEI 2431314
2025-1670Form FDA 483, FEI 3014967552
2016-1191K813227
2022-2549K041331
2016-10419K072412
2017-9498K102567, K161579
2022-8637K160433, K193067, K201346
2025-2143Form FDA 483, FEI 3027737826
2019-3071K024301, K073484
2020-8622K103411
2018-9262K170584, K170891, K172301
2021-6989K090891, K091882, K093002
2016-1187K142065
2025-1087K904971
2016-3321K072647
2019-1261K050918
2014-8120K092150
2017-6486K091010
2024-3320P210025
2016-9692K111863, K130387
2018-10099K111597
2017-2823K153661
2017-666K010309
2020-3760P830035
2018-6478K063349
2021-8545K003064, K063663, K080634
2025-10654K131908
2023-9062Form FDA 483, FEI 3002754162
2021-8242Form FDA 483, FEI 2518422
2020-8083K162471
2025-8345Form FDA 483, FEI 3006946276
2023-6525FEI 3005955744
2024-806P070026
2025-11150K062779, K150569, K182080
2014-9391K121291
2022-8061K011584
2015-6830K033967
2021-2640FEI 3011278888
2023-9625Form FDA 483, FEI 3015259710
2025-2221K231061
2018-7981K152551, K160793, K171695
2023-8138K150549
2023-9533Form FDA 483, FEI 3011103478
2016-3169K012372
2020-3630K040485, K993148
2018-7576K152276
2023-7711Form FDA 483, FEI 2435300
2020-8009K170869
2019-9830FEI 7695
2021-676K202769
2023-6223K210851
2018-10148K103319
2014-8083K022834
2023-9435Form FDA 483, FEI 1946929
2014-8435K112909
2025-144K242269
2019-1400K180151
2017-1782K051477, K062541
2019-8942K170396
2023-6032K222010
2015-8432K082946, K132068, K141963
2018-1219K172935
2019-8211K141102, K141520, K142554
2021-2762K060479
2019-6450K142480
2016-972K081076
2024-8649K193190
2014-7971K023087
2016-977K030774
2025-9256Form FDA 483, FEI 3009973354
2020-2842K091754
2018-10017K163188
2016-3219K090414
2019-6425K060679
2016-9310K152952, K160294, K160295
2018-9965K152319, K173760
2016-9036K051504
2017-4254K140381
2015-8235K042694
2025-862K162428, K210851
2015-50K140615
2014-8257K092119
2016-6871K141077
2015-505K030834
2023-9246FEI 1819470
2017-3540K122609
2017-9394K940422
2016-8684K122184
2017-7142K120781
2015-9975K030859
2019-9027K172848, K172884, K173214
2017-3031K062779
2017-10818K123487
2021-1645K191402
2019-3735K170540
2016-7586K021896
2025-4291Form FDA 483, FEI 3011158388
2016-8665K142672
2024-4690Form FDA 483, FEI 3002807257
2016-1413K142516
2019-1816K160597
2016-5749K150020
2022-5230K220481
2024-4240K123806
2025-3320K113351, K142012, K853253
2022-6373K220090
2016-8464K062458
2018-4619K030009
2022-8706K193293
2024-6081K153359
2026-7845Form FDA 483, FEI 3004455125
2024-6258Form FDA 483, FEI 3021343210
2026-8700Form FDA 483, FEI 3002768909
2015-3809K091935
2016-6485K091106
2026-8121Form FDA 483, FEI 3000209995
2016-8386K141833
2014-8084P020004
2024-976Form FDA 483, FEI 3014833795
2023-9997K173156
2025-815Form FDA 483, FEI 3014607865
2022-8031Form FDA 483, FEI 1000513101
2025-1927K122899
2015-4805K983314
2021-4472K132918
2023-4815K230202
2017-2026K083032, K121682
2023-10014Form FDA 483, FEI 3013248720
2015-5395K083759
2016-6644K150203
2021-2196K030382
2026-6518K252438
2019-4109K971849
2025-11346K172825
2016-7637K933767
2023-10290Form FDA 483, FEI 1315756
2018-7119K140273, K160598, K172790
2025-10161K123474
2023-5241FEI 2182207
2021-279K970824

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