FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
15457–15480 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 2021
Aesculap Slim Clip Applier
K211572 · HCI
Aesculap, Inc.
Neurology · 206d
Cleared Dec 13, 2021
Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)
K211942 · NGX
Shenzhen Osto Technology Company Limited
Physical Medicine · 173d
Cleared Dec 13, 2021
neXus Ultrasonic Surgical Aspirator System
K212060 · LFL
Misonix, Inc.
General & Plastic Surgery · 165d
Cleared Dec 13, 2021
Philips Radiology Smart Assistant
K212186 · KPR
Philips Medical Systems Dmc GmbH
Radiology · 153d
Cleared Dec 13, 2021
Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800...
K212221 · DHA
Diazyme Laboratories, Inc.
Chemistry · 150d
Cleared Dec 13, 2021
Centerpiece Plate Fixation System
K212428 · NQW
Medtronic Sofamor Danek
Orthopedic · 131d
Cleared Dec 13, 2021
SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
K212706 · OBR
Splintek, Inc.
Dental · 109d
Cleared Dec 13, 2021
Disposable Surgical Gown, Disposable Reinforced Surgical Gown
K212869 · FYA
Fugou County Shenxiang Manufacturing...
General Hospital · 95d
Cleared Dec 13, 2021
Nyquist.IQ
K212890 · JAA
Omega Medical Imaging, LLC
Radiology · 94d
Cleared Dec 13, 2021
Heat StimPlus
K212918 · NUH
Famidoc Technology Co., Ltd.
Neurology · 90d
Cleared Dec 13, 2021
Nitrile Examination Gloves
K212924 · LZA
Shanxi Nacosa Medical Technology Co.,Ltd
General Hospital · 90d
Cleared Dec 13, 2021
Disposable Surgical Gown
K212925 · FYA
Henan Robestain Medical Products Co.,...
General Hospital · 90d
Cleared Dec 13, 2021
CoLink NeoFuse Plating System
K213069 · HRS
In2bones USA, LLC
Orthopedic · 81d
Cleared Dec 13, 2021
Disposable Nitrile Powder-Free Examination Gloves
K213176 · LZA
Anhui Zhong Lian Latex Gloves...
General Hospital · 76d
Cleared Dec 13, 2021
MULTIX Impact, MULTIX Impact C
K213700 · KPR
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared Dec 11, 2021
Siam NTD+ Nitrile Powder-Free Examination gloves
K212085 · LZA
Siam Ntd Corporation Co., Ltd.
General Hospital · 162d
Cleared Dec 11, 2021
Iconic Nitrile Glove
K212182 · LZA
Iconic Medicare Sdn Bhd
General Hospital · 151d
Cleared Dec 11, 2021
Nitrile Gloves (Model: NE01)
K212840 · LZA
Byd Auto Industry Company Limited
General Hospital · 95d
Cleared Dec 11, 2021
Medical Surgical Mask
K212867 · FXX
Nanchang Kanghua Health Materials...
General Hospital · 94d
Cleared Dec 11, 2021
Disposable Vinyl/Nitrile Blend Medical Examination Gloves
K212899 · LYZ
Bytech Dongtai Co., Ltd.
General Hospital · 89d
Cleared Dec 10, 2021
Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26,...
K201600 · FLL
Kangfu Medical Equipment Factory
General Hospital · 546d
Cleared Dec 10, 2021
AMG PMP Infant
K202510 · DTZ
Eurosets S.R.L
Cardiovascular · 466d
Cleared Dec 10, 2021
Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level...
K203539 · FYA
Unicoglobal, Inc.
General Hospital · 372d
Cleared Dec 10, 2021
Dental Scaler and Air Polisher
K203615 · ELC
Guilin Woodpecker Medical Instrument...
Dental · 365d