Data catalog

FDA FOIA requests

About 15K records

More records

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

2022-4970P200044
2025-3529K231060
2023-5196Form FDA 483, FEI 3009840089
2024-8591K161686
2023-6516K183078
2024-529Form FDA 483, FEI 3006059109
2024-709K040383
2023-5786EIR, FEI 3006258094
2024-3865K221683
2015-8968K141617
2016-2535K120087
2019-2233K172144
2025-12331K142078
2025-11098Form FDA 483, FEI 3008493238
2025-7159EIR, FEI 3003485793
2023-4799K160965
2019-7712K122528, K130419, K132028
2017-573K140472
2025-7115Form FDA 483, FEI 1000221463
2026-1648Form FDA 483, FEI 3008776287
2022-4025K220195
2021-1667K201631
2016-3170K070910
2023-927K150893
2025-3757K011387
2016-10497K123666
2016-1275K150409
2016-5452K061863
2024-3928Form FDA 483, FEI 3009435759
2016-8927K133884, K150571
2023-8173K122361
2023-5536Form FDA 483, FEI 1220648
2016-4499K153203
2023-9447K021012
2020-8185K201756
2022-5765K110719
2023-9553Form FDA 483, FEI 3004107906
2023-7821K061597
2017-6416K111705
2017-9664K932786
2015-722K102420
2019-7110K182580, K182714
2014-9022K103214
2016-7088K042750
2015-6014K143531
2021-568K110389, K141806, K160597
2024-7543Form FDA 483, FEI 3010477
2020-6652K182456, K192415, K200948
2015-7919K081475
2019-816K170568
2024-4168Form FDA 483, FEI 3024987432
2025-2229Form FDA 483, FEI 1819470
2014-9215K103059
2017-7793K120250
2025-14329Form FDA 483, FEI 3014507910
2025-4436Form FDA 483, FEI 1037559
2022-725K210142
2014-9297K033954
2023-5377Form FDA 483, FEI 3006258094
2016-6459K962283
2023-2263K011132, K050002, K182036
2016-4629K012648
2017-2385K163118
2017-9034K061451
2026-6784Form FDA 483, FEI 3009662229
2016-2727K142272
2021-5154Form FDA 483, FEI 3006542438
2019-2855K941488
2022-2934K212522
2025-12127Form FDA 483, FEI 3005726885
2020-7142K103682
2025-2172Form FDA 483, FEI 2243072
2018-8668K142359
2024-5659Form FDA 483, FEI 3003593973
2025-4074Form FDA 483, FEI 1000118715
2019-11344K063505, K071328, K081656
2026-7249Form FDA 483, FEI 3009540749
2017-123K140751
2026-7460Form FDA 483, FEI 1000221028
2016-8818K153756
2026-6777Form FDA 483, FEI 2450054
2019-11832FEI 1110315
2023-4475K202623
2024-7392K190043
2018-850K021317
2017-1647K092467
2017-2916K143589
2019-5048K081410
2019-10045K070180, K092910, K093438
2019-3363K142870
2022-6818Form FDA 483, FEI 3010251529
2016-1002K982830
2019-4070K182003
2016-3678K006110, K053137, K071713
2025-851Form FDA 483, FEI 3008706707
2015-2251K904422, K934261
2023-2585Form FDA 483, FEI 1000103389
2019-6901K042095
2023-5938Form FDA 483, FEI 3009348673
2015-6323K122797
2024-5640Form FDA 483, FEI 1819470
2024-9643K202337
2023-4500Form FDA 483, FEI 3004170064
2026-7401Form FDA 483, FEI 3001237365
2019-10570K163188
2023-7436K033324, K043115, K050336
2015-394K043299
2020-4859K861276
2022-8109Form FDA 483, FEI 3017936974
2016-1064K152857
2026-7439Form FDA 483, FEI 1313046
2021-8688K203040
2019-3205K181269
2017-1185K160131, K161682
2015-3202K014063
2022-5711K201572
2022-2532K051814
2018-545K151296
2021-5253K151199
2020-3016K003075, K062093, K120931
2024-9723Form FDA 483, FEI 3009424796
2015-9616K141620
2018-9256K050456
2022-4022Form FDA 483, FEI 3007594734
2014-9941K032104
2015-4986K992868, K992893
2018-9530K131410
2025-3939Form FDA 483, FEI 3011430871
2018-4292K910091
2016-7616K151907
2020-7578K161330
2023-2314Form FDA 483, FEI 3002713667
2022-5174K160136
2019-10716K033688, K963376
2024-3999K081672, K102130
2025-6967K213971
2018-4479K050896, K091505, K152626
2026-7394Form FDA 483, FEI 3015200642
2015-4879K122132
2019-10329K002552
2019-11631K053417
2016-8686K140933
2019-10279K171530
2017-5681K151179
2020-2828K193202
2023-5619K081472
2015-2896K952737
2025-2739K233297, K242086, K243359
2022-5443K182887
2015-9706K003915
2020-688K162613
2024-1384Form FDA 483, FEI 3008237827
2018-657K153049
2016-7754K930622
2019-9776K003395, K123365, K142432
2016-6384K890749
2021-1231K182618
2023-603Form FDA 483, FEI 3014175039
2015-3586K021176
2016-997K093141
2017-470K010949
2023-2322P180001
2025-12396FEI 1413399
2020-7386FEI 405
2026-6513Form FDA 483, FEI 2013342
2025-11351Form FDA 483, FEI 3016560486
2025-12312K010558
2024-171Form FDA 483, FEI 2112667
2019-5568K122584
2022-5315K161623
2018-83K123720, K133901
2016-473K012937
2021-4541K190898, K191564, K191658
2020-4343K172677
2016-4656K053189
2015-450K970052
2016-7015K152086
2015-4911K043112
2016-1556K143233
2025-2701K240290
2022-3037K972324
2021-4095K113708, K182396, K780181
2015-6578K112437
2026-4754K861985
2018-9141K182121
2017-6123P160013
2020-173P960009, P960009S351
2023-1744Form FDA 483, FEI 3007042661
2016-9520K123935
2017-4741K945869
2017-2933K140828
2019-4600K123710
2015-6138K123435
2025-11562Form FDA 483, FEI 3004069780
2021-2718K925111
2016-8257K051072, K080911
2024-2606K961085
2016-5209K040067, K043465
2026-1114Form FDA 483, FEI 1210580
2016-4187K100874, K160259
2016-935K980448
2016-1204K130847
2017-9021K013597, K062438
2017-5604K122516
2016-6168Form FDA 483, FEI 4442
2026-7177Form FDA 483, FEI 2450054
2015-7358K103110, K123279, K130391
2023-128Form FDA 483, FEI 3001451453
2022-3443K181288, K200828
2019-9590K102909, K111066, K120831
2018-9243K062792, K133033, K831320
2026-5836Form FDA 483, FEI 2938401
2023-7191K873356
2022-7079Form FDA 483, FEI 3010009693
2016-8308K141685
2023-2811Form FDA 483, FEI 2081040
2024-9653Form FDA 483, FEI 1221765
2018-2467K160974
2024-9882K895513
2019-6478K150378, K161307
2023-3802K182497
2020-2575K002351, K003917, K022350
2019-7709K110586, K110619, K113546
2023-9465Form FDA 483, FEI 3005636544
2016-9550K132148
2024-7771Form FDA 483, FEI 3010867648
2023-3658K140941
2022-4224K201977
2018-2545K091869
2017-10691K143538
2025-4323K241663
2016-1756K040183
2019-1007K153705
2026-5105Form FDA 483, FEI 3005841768
2015-6316K955293
2016-669K140911
2020-3764K071798
2016-4979K010911
2025-13096Form FDA 483, FEI 3014680716
2016-9518K143153
2023-6897Form FDA 483, FEI 3013682457
2022-1546FEI 3002806778
2022-8452Form FDA 483, FEI 3015399803
2026-5470Form FDA 483, FEI 3004932373
2020-4890K962137
2021-3328K190680
2025-2424K143253
2019-6263FEI 8030673
2017-4786K150267
2016-8469K073088
2023-4532K220634
2025-12215Form FDA 483, FEI 3010887638
2021-3039K201975
2015-598K083227
2016-600K121771
2019-10812K183647
2026-6472FEI 3002808445
2024-5863K002808
2016-3948K111862
2014-8019K052188, K120494, K941799
2019-8747K971745
2021-2945FEI 3011625895
2026-5167Form FDA 483, FEI 2246315
2016-4972K150476
2023-2723K013672
2016-6584K111421
2019-2401K171173
2021-5564K050578
2015-8711K110103
2015-8871K141114
2026-5219Form FDA 483, FEI 1222117
2019-6851K010055
2015-6596K132423
2024-9084FEI 1220423
2022-7994EIR, FEI 3008237827
2024-7004K233875
2017-529K062282
2017-5271K100434
2017-9051K122252
2023-3920H110002
2024-4555Form FDA 483, FEI 3002698769
2017-10255K171120
2024-2572K093679, K122276, K153500
2014-8586K130847
2016-6796K070612
2017-9988K170210
2022-8125Form FDA 483, FEI 1222117
2020-7981K083357
2025-12592K002970, K042359
2022-2695K011208, K033960, K131405
2016-742P290047, P920047
2023-11071Form FDA 483, FEI 2219920
2017-1344K874096
2021-7536K181991
2023-10559K222327
2017-10136K050114
2018-6688K061815
2023-707Form FDA 483, FEI 3003169040
2016-3016K071638
2019-1616K152304
2025-9337FEI 3004753838
2016-4235K101250
2017-1275EIR
2020-4370K093106
2022-587K161605
2016-315K962956
2018-8507K171003
2019-9771K132817, K141141, K150771
2025-2420K033357
2025-11124K240728
2021-8110FEI 3015007456
2023-6517K222010
2025-10431Form FDA 483, FEI 3007965489
2024-2930Form FDA 483, FEI 1049818
2016-6096K113479
2016-968K023830
2015-10256K021791, K023750, K030736
2022-8308Form FDA 483, FEI 3003500908
2024-68Form FDA 483, FEI 3003429569
2016-3183K152356
2023-3714Form FDA 483, FEI 3007515144
2019-11274K160561
2024-10953K031463
2023-5461FEI 3002485711
2022-8302P890055
2016-12K050770
2015-1821K141560
2017-7581K101262
2022-2957K032226, K073707, K092148
2016-4151K140389
2022-4632K010455, K090209, K111822
2020-6171Form FDA 483, FEI 3009109670
2017-1161P070004
2024-6706Form FDA 483, FEI 3003015552
2016-3051K113565
2016-6054K143643
2016-2470K052289
2019-11266K160968
2020-6183K182497
2019-11643K172073
2023-10198Form FDA 483, FEI 1219183
2014-9839K132429
2021-605K103305, K123712, K143218
2019-3739P150004
2023-6022K020566
2017-2985K924724
2019-1091K173860
2020-1111FEI 3715
2017-9878P120005
2017-4478K163401
2018-8971Form FDA 483, FEI 3343
2019-1566K180744
2023-3656K220540
2024-7281Form FDA 483, FEI 1928237
2015-2639K002099
2025-1617K242086, K243213
2016-10570K090671
2021-52K000578
2019-6914P160045
2017-4234K092467
2015-6829K010710
2024-1769K170874, K173156, K192004
2023-2821Form FDA 483, FEI 3014539253
2021-8251K103233
2015-5079K091499
2018-4366K932367
2022-3578FEI 3013718163
2015-7053K131629
2025-7457K242604
2018-5243K131305, K150861, K162172
2017-132K143153
2023-10415Form FDA 483, FEI 2242547
2022-1648Form FDA 483, FEI 2242327
2019-6220K162193
2019-8004K924731, K924732, K930041
2018-8666K151554
2019-1140K130689
2017-7576K080807
2018-3690P980022
2022-1235P970003
2026-1498Form FDA 483, FEI 3004444888
2024-9570Form FDA 483, FEI 3005906887
2015-3414FEI 1841
2022-6824K962587
2019-4332K160540
2016-1330K813388
2022-7305Form FDA 483, FEI 3016743107
2016-3454K150603
2023-1670K192388, K200232, K203550
2018-5597K971794
2022-4943FEI 3002808331
2015-1859K132121
2025-1380Form FDA 483, FEI 3015238043
2021-268K855121
2015-7864K141133
2015-5212K130802
2023-11354Form FDA 483, FEI 3008500974
2023-9540K140586, K152954, K223797
2016-7341K143612, K151650
2022-217K203641
2019-6778K162309, K172820
2026-1682Form FDA 483, FEI 3008879776
2014-8867K113231
2025-343Form FDA 483, FEI 3011393407
2019-7210K103512
2019-4418K181594
2025-10154Form FDA 483, FEI 3010484784
2023-3112Form FDA 483, FEI 3003681915
2023-4242K063148, K161756, K181557
2021-3814K192785
2021-4892Form FDA 483, FEI 3004595684
2025-2870Form FDA 483, FEI 3015045325
2016-2362K150453
2017-3638P050020
2024-10390EIR, FEI 1218077
2018-6790K173675
2020-4713K151168
2023-3089Form FDA 483, FEI 3003166194
2018-6678K090140
2020-5251P040029
2024-8680Form FDA 483, FEI 3011277306
2022-5257K200461
2023-4101Form FDA 483, FEI 3005651716
2016-9557K003964
2025-674K924509, K925988
2023-8211K222318
2023-6007Form FDA 483, FEI 3017520337
2025-7066Form FDA 483, FEI 3014133165
2019-2405K121688
2025-7771K230829
2015-6165K110327, K113285
2026-5337Form FDA 483, FEI 3004181163
2026-6894K222601
2022-455Form FDA 483, FEI 2518422
2016-9971K160959
2015-8807Form FDA 483, FEI 6433
2015-176K130651
2024-8028Form FDA 483, FEI 405
2018-8603K162812
2015-5329K083019
2025-9224Form FDA 483, FEI 3000203391
2014-8453K020802
2024-7685Form FDA 483, FEI 3005021818
2015-406K143189
2024-3735K202839
2023-10741Form FDA 483, FEI 2017865
2018-6765K171120
2026-4415Form FDA 483, FEI 3001413302
2019-5891K191450
2021-5280Form FDA 483, FEI 3003591774
2023-3511K181153
2025-3712EIR, FEI 3007389669
2015-6686K900770
2022-4623P130022
2016-6546K110116
2021-5037P140029
2022-378K182853
2019-1915P850038
2024-7244Form FDA 483, FEI 3004142400
2018-2250K171442
2016-9048K132021
2017-5010K150826
2023-10586K160907
2019-8228K040129, K063677, K970052
2019-9593K001334, K001773, K032232
2025-7364Form FDA 483, FEI 3016467917
2017-9847K152033, K153754
2023-2287P030002
2025-7381K233747
2025-13029K231481
2017-214P070004
2019-6936K162098
2015-8035K092581
2017-2423K973924
2019-2377K141617, K163549
2024-10124K010680
2022-6163FEI 3015143068
2016-10561K103253, K110004
2024-1399K213670, K213953, K230855
2024-6248Form FDA 483, FEI 1818911
2019-11822K181016
2020-6083K111992
2015-7972K000080
2018-1799P850035
2022-7577K192048
2025-13095Form FDA 483, FEI 3002924544
2021-3708Form FDA 483, FEI 3011680766
2016-7314K140933
2016-10122K124030
2021-4958K142491
2017-8966K140866
2016-6385K891372
2016-5558K160526
2020-1986K063377, K072549, K090512
2021-3458K133725
2020-7452K820183
2023-1379P970038
2018-5845K171050
2024-1722Form FDA 483, FEI 3005949964
2025-13134K251733
2018-9595P820063
2020-7669K051647, K083811, K090131
2024-1794Form FDA 483, FEI 1000654629
2017-6457K081467
2022-1791FEI 3005433617
2021-2743K021362, K143054, K191006
2015-170K133237
2015-8696K131122
2017-6780K152725
2014-9205K111695
2023-8574K201271
2019-6198K031332
2022-5148K142461
2023-3665K041007, K142461, K181661
2016-6339K100534
2017-4467K161656
2018-570K014274
2017-6394K163401
2019-8659K041007
2026-6759Form FDA 483, FEI 1000119582
2022-6958Form FDA 483, FEI 3005663073
2024-5159EIR, FEI 3007611554
2017-6901K170469
2019-2682K071671
2020-7178Form FDA 483, FEI 3006990600
2017-4533K162330
2019-3975K190038
2023-3528K161461
2026-9158Form FDA 483, FEI 1220908
2021-3358K162524
2015-8413K080383, K121275
2016-9361K091869, K101193, K110257
2025-4656Form FDA 483, FEI 3002807111
2019-2842K152490
2025-11076K210176
2014-9009K004009
2017-31K023213, K023896, K882491
2015-6720K132403
2018-2226K962485
2022-5442K183416
2021-6255K203570
2019-3996K162248
2017-2643K100081
2020-4537K110306, K190555
2023-6776K171414
2022-3132K173196
2020-6936K134031
2020-4099K143675
2021-8677K173402
2017-9061K080006
2018-5426K090288
2024-8593K131982, K140124, K200480
2020-2481K090131
2020-2382K083811
2017-1642K153660
2017-7219K161457
2016-3826K060298, K080587, K093789
2026-6816Form FDA 483, FEI 1000115753
2023-4327Form FDA 483, FEI 3009941480
2021-3747K140151
2015-2644K142432
2017-3975K130233, K133408, K160703
2016-9215K935296
2023-6314Form FDA 483, FEI 3015451503
2025-3911Form FDA 483, FEI 3008146975
2016-4653K123862
2023-5088Form FDA 483, FEI 3008775608
2025-4501Form FDA 483, FEI 1120041
2021-5775K182732
2024-1993Form FDA 483, FEI 1000087290
2018-8149K170059
2017-131K151635
2017-2068K990642
2023-2935K142969, K151911, K160761
2023-8193K120555
2017-10110K153727
2016-3065K141474
2024-5662Form FDA 483, FEI 3025488663
2015-10191K020862
2025-9482K250133
2023-5439Form FDA 483, FEI 3002755653
2026-5848Form FDA 483, FEI 1000098753
2023-7519Form FDA 483, FEI 1000221028
2016-8806K142517
2020-4239K152748
2019-7803Form FDA 483, FEI 5833
2017-4884K161865
2016-9235K143563
2024-6552Form FDA 483, FEI 3011660785
2025-2423K131773
2020-4981K023594, K111831, K173388
2014-8665K051321, K090413
2023-7168K191070
2024-3933Form FDA 483, FEI 3010119775
2023-6925Form FDA 483, FEI 3012307300
2021-159K090095, K090996, K091160
2023-5946K122702
2023-10781Form FDA 483, FEI 3009768528
2020-6130K192105
2025-1669Form FDA 483, FEI 3014607865
2018-9446K140819
2024-6842K923065
2017-3016K032119
2023-2474K173274
2021-8773K211818, K212456
2020-6091K112791
2025-11300Form FDA 483, FEI 5634
2015-618K072370
2015-928K113276
2023-10303K210635
2026-9358Form FDA 483, FEI 3003793491
2018-2311K023086, K023562
2026-5789K040163, K861985
2023-3520Form FDA 483, FEI 3010197287
2015-750K120150
2014-9147K121481
2026-5134Form FDA 483, FEI 3027395815
2017-8842K081858
2020-2362K103556
2025-10735K931368
2023-10885Form FDA 483, FEI 1417592
2024-7541Form FDA 483, FEI 1220423
2025-11917K081512
2025-2885Form FDA 483, FEI 3002701146
2016-2142K140920
2016-2195K062789
2023-3828Form FDA 483, FEI 2914537
2025-2732K242825
2024-5633Form FDA 483, FEI 3013726944
2023-6740FEI 1000314502
2024-2965Form FDA 483, FEI 3010892830
2024-1018K232761
2019-4655K181439
2016-3504K133589
2015-274K140439
2018-4779K151909, K152093, K161598
2016-6768K901138, K945775
2014-7991K083358
2018-9756K181904
2019-6640K182075
2022-7550P130022
2019-6304K103302, K113566
2015-727K131870
2016-5926K123402
2021-8690K210668
2024-7252FEI 3004142400
2025-3167Form FDA 483, FEI 3015045325
2017-7630K120800, K121195
2023-2264K101889, K152127, K181038
2014-9251K914570
2015-8130K110253
2025-13763K250397
2022-7004Form FDA 483, FEI 3008513398
2023-10676Form FDA 483, FEI 1051786
2019-8279K151159
2025-6962K172601
2015-3823K122538
2021-6324FEI 4321
2018-468K063785
2019-1708K070743
2015-7108K120033
2025-1460Form FDA 483, FEI 2183715
2023-8509K111380
2024-2124K002892, K041424, K050525
2016-7353K132841
2016-4430K151649
2019-8986K163399
2015-7869K151204
2020-8203K193483, K200467, K201214
2020-2349P120020
2019-1703P140031
2018-6267K151604, K980025, K980027
2024-785Form FDA 483, FEI 3010031134
2024-1945Form FDA 483, FEI 3006845464
2026-6394Form FDA 483, FEI 6612
2022-3382K142922
2021-3186K103556, K173780, K181955
2018-8393K180068
2020-4475K905765
2026-6707K261068
2020-4555EIR, FEI 2648209
2023-7944K162240
2020-7103K970889
2020-7914EIR, FEI 1000121052
2025-7380K250307
2022-3925FEI 3010536692
2023-2700K192107
2021-968K192880
2026-8489K250109
2023-10034K202166
2026-9170FEI 1220908
2022-340K181704, K192287, K193229
2022-3703K113871
2025-12462K860028
2016-9110K083127, K101659, K133539
2026-1052K041502, K042423, K051231
2026-1388Form FDA 483, FEI 2130687
2023-2840K120897
2023-9876K232205
2025-12338K121363
2019-12043K181612
2024-7436FEI 3002803444
2025-4486K180346, K230199
2018-7384P950008
2026-8789Form FDA 483, FEI 3015436853
2022-5927Form FDA 483, FEI 3007594734
2016-4702K872018
2025-1921K133335
2018-7153K083050, K093633, K121975
2022-8801K171392
2016-4718K103311
2017-9755P820088
2020-4674K150222
2014-9280K090949
2023-10207Form FDA 483, FEI 3015775839
2019-7497K013630, K083152, K120384
2025-10496Form FDA 483, FEI 3011508621
2017-3651P120010
2015-7973K071092
2016-5312K974479
2018-9594P820063
2015-4236K093321, K100985, K143022
2022-6288K023969
2020-8497Form FDA 483, FEI 1717046
2019-10544K173327
2019-4069P080003
2023-8807Form FDA 483, FEI 3002836339
2021-2694K013651, K984294, K990800
2017-6447P130028
2015-2643K141399
2016-2638K790213
2018-29K170982
2014-8043K023238
2021-8819K111426, K142327, K181704
2017-10628K161582
2017-6896K163253
2016-6582K111935
2018-6336K163686
2017-4863K062849
2014-9980K101769
2017-3169K030625
2017-9215K040980
2022-888FEI 3015399803
2017-8167K140310
2025-3889Form FDA 483, FEI 3003007868
2014-10012K010388
2021-2462K162784
2016-6046K052931
2015-5279K113070
2023-2288P030002
2025-10426K842224
2023-10572Form FDA 483, FEI 1717226
2020-1553K123904
2022-7573Form FDA 483, FEI 3010405304
2025-2909Form FDA 483, FEI 2183873
2022-7521K103783, K143120, K183598
2023-4200Form FDA 483, FEI 3008514120
2026-4413Form FDA 483, FEI 3002958688
2018-1594K160615
2019-9851K112168, K113449, K141272
2026-1417Form FDA 483, FEI 3013020160
2023-11190Form FDA 483, FEI 3000251573
2015-549K141771
2025-143K233557
2019-11170K151911, K172396, K191660
2015-7305K143001
2021-163K161355, K171610, K172356
2024-8676Form FDA 483, FEI 1220672
2019-7209K153486
2021-645K130122, K130864
2015-7463EIR, FEI 2523928
2021-2219K946257
2017-10772K083597, K112469, K992304
2022-7839EIR, FEI 1220649
2017-4927K972093
2026-8290P170036
2023-3645K192162
2019-10202K842233, K892059, K960425
2015-5014K142480
2023-9589EIR, FEI 3002199759
2020-3498K182964
2014-9861K930511
2016-2164K041363
2017-10380K113294
2023-6407K041874
2024-8488K181451, K220606, K221683
2024-1781K231307
2025-9262Form FDA 483, FEI 3014539253
2016-2544K106417, K150786
2025-2766Form FDA 483, FEI 3003164255
2016-7944Form FDA 483, FEI 5714
2021-8492K172735
2021-5746K201906
2019-11694K110456
2024-5782Form FDA 483, FEI 3002806534
2017-2127K102507
2020-4922K191407
2024-1004Form FDA 483, FEI 3006648320
2019-581K032522, K112470
2017-4350K061148, K072016, K122376
2020-7685K181704
2020-1762K181262
2015-9376K990801
2019-7086K080555, K080930
2017-6497K110486
2017-10227K161212
2023-9326Form FDA 483, FEI 3009234552
2017-4718K133598
2018-10108K040558
2022-2306K201634
2015-6635K042501
2023-5339K230358
2016-4680K761179
2018-7589K180026
2020-2150K032612
2015-7672K073168, K112535, K792558
2015-136K030685, K112679
2021-425K201308
2025-13542K223609
2018-5770K062282
2019-4943K112782, K190160
2023-1035K894756
2021-4619K141069
2019-10216K112692
2016-3435K153466
2026-7252FEI 5896
2026-8735Form FDA 483, FEI 2020808
2019-8275K091158, K112802, K122158
2021-3449K101542
2020-489K090626
2014-9106K140853
2021-225K193670
2020-7569K150708, K153449, K173972
2023-5967K140929, K150365
2020-2111K161328
2023-7131K212217
2025-10737K093972
2019-8232K061248, K071733, K123128
2024-8017K081998, K103738, K112485
2019-4973K103767
2026-8295P170036
2023-10349K212224
2022-6390K153485
2026-8697FEI 1220648
2018-7248K921470, K921471
2023-49K210187
2017-5175K092359
2023-3747FEI 3010836847
2019-7852K142649
2019-8653K181867
2020-8824K201865
2018-1595K040011, K060065, K950388
2022-3383K130752, K141877
2025-4197Form FDA 483, FEI 3010728384
2015-7918K141935
2016-5186K113550
2023-2275Form FDA 483, FEI 1937980
2015-7675K142327
2022-4219K093718, K123704
2023-5352K212303
2025-3893Form FDA 483, FEI 3008855505
2014-9645K013630, K942120, K955092
2018-8021K171827
2023-11467Form FDA 483, FEI 3007513035
2026-6573Form FDA 483, FEI 3013300026
2023-1093K152494
2026-8629K172492
2016-10204K093146, K093995, K141745
2021-604P110042
2022-2568FEI 3004065885
2016-1355K132643
2022-8180FEI 3002757680
2023-3368Form FDA 483, FEI 3015209038
2015-10157FEI 4460
2025-14321K010987
2021-7527K192667
2023-1603Form FDA 483, FEI 3014680149
2015-8243K950116
2018-6557K153239
2019-2614K121171
2019-542K173620
2025-9409K944395, K964699
2018-352K021442, K021446, K091272
2023-10314K220131
2025-1501Form FDA 483, FEI 3000196378
2023-39K132540
2015-4525K090367, K141946, K142105
2017-8862K943801
2022-2718FEI 2182501
2016-8592K152579
2023-6101Form FDA 483, FEI 3014469173
2022-343K111411
2018-4436K133670, K173409
2015-56K141163
2016-8781K071973
2026-5292K210189, K210298, K241089
2018-117K072764
2015-2324K954311
2025-11927FEI 3005142514
2016-2218K984443
2020-8812K190667
2016-726FEI 1219930
2020-7236P890001
2015-5323K964518
2023-3377K113871
2024-4273K201404
2016-1186K073115
2017-9724K932690, K932776, K933494
2022-2111K882980
2022-6807Form FDA 483, FEI 3003491851
2023-5599Form FDA 483, FEI 3010197300
2016-5382K052731
2020-3435K011530
2024-11208Form FDA 483, FEI 1000524572
2021-161K141997, K150880, K152953
2017-9007K130631
2025-2740K232482
2016-9305K130148
2017-99K131272
2018-1176K120196, K121447
2025-8080FEI 3003350319
2016-1486K141790
2019-5461K152217
2014-9970K142037
2017-1436K160707
2021-6805FEI 1810189
2024-9432K981207
2026-7393Form FDA 483, FEI 3014268427
2016-10125K124030
2018-9018K031373, K111210, K142619
2017-543K161324
2018-7079P030002
2015-5449K140199
2018-9170K113187
2020-4196K812120, K820061
2026-4663Form FDA 483, FEI 1216602
2017-625K161631
2020-8473FEI 3002806285
2014-8389K954504
2026-8805Form FDA 483, FEI 3015239144
2022-487K992799
2023-5137P170001
2023-6680K201555, K210791, K222463
2023-7482Form FDA 483, FEI 3000233845
2020-6686K181918
2018-4649K170755
2022-8317Form FDA 483, FEI 3003166194
2026-6512Form FDA 483, FEI 1000117344
2024-2521K182408, K212999, K232033
2018-2912K173388
2015-9328P020014
2024-378Form FDA 483, FEI 2183456
2022-4550FEI 3017544399
2021-384K102965, K110193, K172462
2023-11316Form FDA 483, FEI 1025114
2026-1565Form FDA 483, FEI 3004932373
2026-5289K142879, K172140, K251567
2023-3887K181038
2023-2172Form FDA 483, FEI 3012973796
2024-10466K143094
2016-2194K153080
2023-7497K223860
2025-13077K191388, K232495, K233827
2020-3300K140312
2019-3744FEI 1219343
2021-2017K192762
2025-3934Form FDA 483, FEI 3013986459
2016-956K112728
2015-8214K093475
2018-6310K173675
2026-1994Form FDA 483, FEI 3007899424
2026-4681Form FDA 483, FEI 3003631744
2024-9231Form FDA 483, FEI 1000049086
2022-2481FEI 1417592
2020-4304Form FDA 483, FEI 6955
2023-2465FEI 3004859032
2015-4873K050404
2026-8570Form FDA 483, FEI 3001237145
2016-4123K070242
2019-231K113618
2024-10161K201072
2015-3387K101314
2026-9166FEI 1220908
2015-120K041934, K102893, K132560
2023-10926Form FDA 483, FEI 1000138491
2022-3699K183598
2024-9767Form FDA 483, FEI 3017894900
2014-8184K052917, K992287
2024-3869K210088
2018-7751K101133
2024-1054Form FDA 483, FEI 3002806503
2022-1637Form FDA 483, FEI 3012144557
2019-7501K143480
2021-8692K161399
2021-1044K113422
2021-6646K050503, K142791, K151895
2024-1921EIR, FEI 1219540
2017-136K130131
2018-9999K173637
2021-932Form FDA 483, FEI 3343

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