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FDA Tracker

Every diagnostic 510(k), the day FDA posts it.

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All classesClass IClass IIClass III100 entries · live · openFDA
510(k)
Sponsor
Class
Cleared
K260111
Mytech Intelligence (Shenzhen) Co., Ltd.
II
2026-05-14
K252653
Acist Medical Systems, Inc.
II
2026-05-13
K260846
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
II
2026-05-11
K252558
Philips Ultrasound, LLC
II
2026-05-05
K254099
Samsung Medison Co., Ltd.
II
2026-03-27
K253595
Philips Ultrasound, LLC
II
2026-03-27
K253049
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
II
2026-02-11
K252909
Ningbo Runyes Medical Instrument Co., Ltd.
II
2026-02-03
K253597
Canon Medical Systems Corporation
II
2026-01-20
K252794
Imricor Medical Systems, Inc.
II
2026-01-08
K252018
Samsung Medison Co., Ltd.
II
2026-01-05
K251268
Edan Instruments, Inc.
II
2025-12-23
K252557
Philips Ultrasound, LLC
II
2025-12-22
K251601
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
II
2025-12-03
K252405
Surgical Instrument Service and Savings, Inc.
II
2025-11-26
K253487
Siemens Medical Solutions USA, Inc.
II
2025-11-17
K253457
Siemens Medical Solutions USA, Inc.
II
2025-11-13
K251853
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
II
2025-11-07
K252074
Canon Medical Systems Corporation
II
2025-10-31
K251651
Philips Ultrasound, LLC
II
2025-10-09
K250026
Wuxi Hisky Medical Technologies Co., Ltd.
II
2025-10-01
K251192
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
II
2025-08-22
K251481
Siemens Medical Solutions USA, Inc.
II
2025-08-20
K251455
Philips Ultrasound, LLC
II
2025-07-24
K250913
Jiangsu Tingsn Technology Co., Ltd.
II
2025-07-19
K250999
Samsung Medison Co., Ltd.
II
2025-07-18
K250772
Surgical Instrument Service and Savings, Inc.
II
2025-07-11
K243274
Centers for Disease Control and Prevention
II
2025-07-11
K243252
Zbeats, Inc.
II
2025-07-10
K250310
Boston Scientific Corporation
II
2025-06-27
K250886
Philips Ultrasound, LLC
II
2025-06-18
K243880
Wuxi Hisky Medical Technologies Co., Ltd.
II
2025-06-17
K250545
Surgical Instrument Service and Savings, Inc.
II
2025-06-05
K250024
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
II
2025-05-30
K243793
Philips Ultrasound, LLC
II
2025-05-21
K243411
Nanjing Perlove Medical Equipment Co., Ltd.
II
2025-05-19
K250020
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
II
2025-05-19
K250110
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
II
2025-05-16
K242519
Philips Ultrasound
II
2025-05-15
K242808
Canon Medical Systems Corporation
II
2025-05-13
K251110
Philips Ultrasound, LLC
II
2025-05-09
K242670
Philips Ultrasound
II
2025-05-08
K250228
Esonic Technology (Wuhan) Co., Ltd.
II
2025-04-23
K250177
Philips Ultrasound, LLC
II
2025-04-10
K243298
Carbon (Shenzhen) Medical Device Co., Ltd.
II
2025-04-03
K243931
Centers for Disease Control and Prevention
II
2025-03-14
K250214
Edan Instruments, Inc.
II
2025-02-20
K243702
Samsung Medison Co., Ltd.
II
2025-02-12
K243794
Philips Ultrasound, LLC
II
2025-02-06
K242019
DRGEM Corporation
II
2025-01-07
K240676
Vinno Technology (Suzhou) Co.,Ltd
II
2024-12-16
K242020
Philips Ultrasound, LLC
II
2024-12-12
K242511
Samsung Medison Co., Ltd.
II
2024-12-10
K242225
Surgical Instrument Service and Savings, Inc.
II
2024-11-29
K242444
Samsung Medison Co., Ltd.
II
2024-11-27
K242523
Siemens Medical Solutions USA, Inc.
II
2024-11-19
K242496
Eieling Technology (Shenzhen) Limited
II
2024-11-19
K243299
Siemens Medical Solutions USA, Inc.
II
2024-11-15
K242231
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
II
2024-11-08
K240366
Boston Scientific Corporation
II
2024-11-01
K242809
Medical Graphics Corporation
II
2024-10-17
K241971
Samsung Medison Co., Ltd.
II
2024-10-11
K240980
Philips Ultrasound, LLC
II
2024-10-07
K241201
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
II
2024-09-16
K241432
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
II
2024-09-12
K241582
Canon Medical Systems Corporation
II
2024-09-12
K233433
Medtronic
II
2024-08-07
K240906
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
II
2024-07-23
K240704
Siemens Medical Solutions USA, Inc.
II
2024-07-22
K234091
Genalyte, Inc.
II
2024-07-22
K233453
Life Technologies Corporation
II
2024-07-10
K231015
Innovative Health, LLC
II
2024-07-01
K240631
Samsung Medison Co., Ltd.
II
2024-06-21
K240684
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
II
2024-06-17
K233613
Siemens Medical Solutions USA, Inc.
II
2024-06-12
K240516
Samsung Medison Co., Ltd.
II
2024-06-12
K233825
Innovative Health
II
2024-06-07
K241110
Centers for Disease Control and Prevention
II
2024-05-21
K233841
Qingdao Hisense Medical Equipment Co., Ltd.
II
2024-05-16
K232895
Contec Medical Systems Co.,Ltd
II
2024-05-03
K232908
Contec Medical Systems Co.,Ltd
II
2024-05-02
K240850
Philips Ultrasound, LLC
II
2024-04-24
K240115
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
II
2024-04-22
K231930
Guangdong Youkey Medical Co., Ltd.
II
2024-03-22
K233439
Qingdao Hisense Medical Equipment Co., Ltd.
II
2024-02-21
K231659
Medisono
II
2024-02-15
K233788
Philips Ultrasound, LLC
II
2024-02-13
K233401
Eieling Technology Limited
II
2024-02-12
K233195
Canon Medical Systems Corporation
II
2024-01-24
K233226
Radical Imaging, LLC
II
2024-01-17
K233112
Samsung Medison Co., Ltd.
II
2023-12-21
K231889
Ultrasound Biotechnology (Shanghai) Co., Ltd.
II
2023-12-21
K233397
Medtronic, Inc.
II
2023-12-02
K233545
Philips Ultrasound, LLC
II
2023-11-30
K232988
Canon Medical Systems Corporation
II
2023-11-21
K232145
Siemens Medical Solutions USA, Inc.
II
2023-10-30
K233207
Boston Scientific Corporation
II
2023-10-27
K231761
Skanray Technologies Limited
II
2023-10-27
K231685
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
II
2023-10-26
K232500
Philips Ultrasound
II
2023-10-26
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