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FDA Tracker

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

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All classesClass IClass IIClass III100 entries · live · openFDA
510(k)
Sponsor
Class
Cleared
K253060
Protect Gloves Company Limited
I
2026-05-22
K240790
Suzhou Colour-Way New Material Co., Ltd.
I
2024-08-23
K232079
Wrp Asia Pacific Sdn. Bhd.
I
2024-03-28
K232444
Grand Work Plastic Products Co., Ltd.
I
2023-12-20
K231973
Ineo Tech Sdn Bhd
I
2023-09-29
K231446
Fitone Latex Products Co., Ltd. Guangdong
I
2023-09-22
K230578
Wrp Asia Pacific Sdn. Bhd.
I
2023-08-31
K230079
Ansell Healthcare Products, LLC
I
2023-08-23
K222993
Sentienx Sdn Bhd
I
2023-08-18
K230832
The Egyptian Company For Medical & Electronic Industries
I
2023-08-16
K230304
Puyang Linshi Medical Supplies Co., Ltd.
I
2023-08-09
K230217
Grand Work Plastic Products Co., Ltd.
I
2023-05-13
K222350
Jr Engineering & Medical Technologies (M) Sdn. Bhd.
I
2023-04-13
K222620
Suzhou Colour-Way New Material Co., Ltd.
I
2023-03-23
K221424
New Era Medicare Sdn. Bhd.
I
2023-01-26
K222058
Wrp Asia Pacific Sdn. Bhd.
I
2022-10-22
K221718
Hartalega NGC Sdn. Bhd.
I
2022-09-24
K221748
Guilin Hbm Health Protections, Inc.
I
2022-09-13
K214074
Hartalega NGC Sdn. Bhd.
I
2022-05-26
K211953
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
I
2022-05-25
K212596
Amazing Rubber Products Pvt, Ltd.
I
2022-03-01
K212848
Pentavest Holdings Sdn Bhd
I
2021-12-27
K211621
Careplus (M) Sdn Bhd
I
2021-10-06
K201592
Cardinal Health200, LLC
I
2021-09-26
K211478
Aspen Glove Sdn. Bhd.
I
2021-09-16
K210724
Careplus (M) Sdn Bhd
I
2021-08-03
K203538
Medline Industries, Inc.
I
2021-08-02
K200915
Gx Corporation Sdn Bhd
I
2021-07-09
K210656
Careplus (M) Sdn Bhd
I
2021-06-24
K203030
Wrp Asia Pacific Sdn. Bhd.
I
2021-06-11
K202765
Careplus (M) Sdn Bhd
I
2021-05-27
K202401
Eco Medi Glove Sdn. Bhd.
I
2021-02-17
K203483
Guilin Hbm Health Protections, Inc.
I
2021-02-01
K192933
Emerson & Co. Srl
I
2021-01-13
K202668
Medline Industries, Inc.
I
2020-12-19
K202090
Molnlycke Health Care Us, LLC
I
2020-11-22
K202449
Medline Industries, Inc.
I
2020-11-18
K201748
Hartalega Sdn Bhd
I
2020-10-02
K201774
Pt. Medisafe Technologies
I
2020-09-16
K201829
Medline Industries, Inc.
I
2020-09-09
K200897
Hartalega Sdn Bhd
I
2020-06-01
K193217
Medline Industries, Inc.
I
2020-04-06
K192988
Medline Industries, Inc.
I
2020-04-01
K191869
Molnlycke Health Care Us, LLC
I
2020-03-13
K192820
Medline Industries, Inc.
I
2020-02-28
K190241
Careglove Global Sdn. Bhd.
I
2019-12-30
K191898
Modern Healthcare Corp.
I
2019-12-18
K183536
Hartalega NGC Sdn. Bhd.
I
2019-08-16
K183389
Hartalega NGC Sdn. Bhd.
I
2019-06-28
K190077
Molnlycke Health Care Us, LLC
I
2019-05-24
K190018
Ansell Healthcare Products, LLC
I
2019-05-23
K182176
Pt. Medisafe Technologies
I
2019-03-28
K182948
Ansell Healthcare Products, LLC
I
2019-03-22
K181047
Smart Glove Corporation Sdn. Bhd.
I
2019-01-09
K180221
Smart Glove Corporation Sdn. Bhd.
I
2018-08-08
K171550
Sanrea Healthcare Products Pvt, Ltd.
I
2018-07-13
K173304
Lucenxia Prescience AG
I
2018-04-30
K173258
Pt. Medisafe Technologies
I
2018-04-20
K173386
Lucenxia Prescience AG
I
2018-04-09
K171375
Ansell Healthcare Products, LLC
I
2018-02-06
K171987
Lucenxia Prescience AG
I
2017-10-20
K171279
Top Glove Sdn. Bhd.
I
2017-10-12
K172420
Wear Safe (Malaysia) Sdn. Bhd.
I
2017-09-29
K171276
Tg Medical Sdn. Bhd.
I
2017-08-21
K171898
Better Care Plastic Technology Co., Ltd.
I
2017-08-18
K171047
Better Care Plastic Technology Co., Ltd.
I
2017-06-22
K170198
Cardinal Health, Inc.
I
2017-06-15
K170515
Primus Gloves Pvt Limited
I
2017-06-09
K170152
Hartalega Sdn Bhd
I
2017-05-05
K162852
Lucenxia Prescience AG
I
2017-02-08
K161823
Wrp Asia Pacific Sdn. Bhd.
I
2017-01-23
K160928
Hartalega Sdb. Bhd.
I
2016-12-20
K161008
Hartalega Sdn Bhd
I
2016-07-28
K160875
Cardinal Health, Inc.
I
2016-07-11
K160501
Noxilizer, Inc.
I
2016-05-26
K153316
Cardinal Health, Inc.
I
2016-05-12
K152428
Medline Industries, Inc.
I
2016-03-31
K151778
Cardinal Health 200, Inc.
I
2016-03-24
K151694
Ansell Healthcare Products, LLC
I
2016-03-09
K151228
Emerson & Co. Srl
I
2016-01-15
K150238
Medline Industries, Inc.
I
2015-11-27
K151607
Lucenxia Prescience AG
I
2015-11-16
K151605
Lucenxia Prescience AG
I
2015-11-16
K142941
Pt. Medisafe Technologies
I
2015-11-02
K151392
Terang Nusa Sdn Bhd
I
2015-09-18
K150973
Terang Nusa Snd Bhd
I
2015-08-04
K142190
Pt. Medisafe Technologies
I
2015-07-14
K140477
Molnlycke Health Care Us, LLC
I
2015-03-23
K140989
Hebei Hongsen Plastics Technology Co, Ltd.
I
2014-12-22
K140355
Terang Nusa Sdn Bhd
I
2014-11-06
K130450
Purna Bina Sdn Bhd
I
2014-09-30
K141719
Molnlycke Health Care Us, LLC
I
2014-09-04
K140988
Hebei Hongsen Plastics Technology Co, Ltd.
I
2014-08-12
K123126
Shanghai Motex Healthcare Co., Ltd.
I
2014-06-04
K132802
Shanghai Motex Healthcare Co., Ltd.
I
2014-05-21
K122557
Shanghai Motex Healthcare Co., Ltd.
I
2013-10-03
K131751
Lucenxia Prescience AG
I
2013-09-25
K123629
Lucenxia Prescience AG
I
2013-05-13
K123628
Lucenxia Prescience AG
I
2013-03-18
K121335
Hutchinson Sante S.N.C.
I
2012-09-13
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