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
17017–17040 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 2021
Coconu Water Based Personal Lubricant
K210814 · NUC
Coconu, LLC
Obstetrics & Gynecology · 89d
Cleared Jun 14, 2021
E-Temp
K211101 · EBG
Envisiontec GmbH
Dental · 62d
Cleared Jun 14, 2021
VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)
K211136 · LON
bioMerieux, Inc.
Microbiology · 59d
Cleared Jun 14, 2021
2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix...
K211518 · MCW
Volcano Atheromed, Inc.
Cardiovascular · 28d
Cleared Jun 13, 2021
Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with...
K210401 · LZA
Ansell Healthcare Products, LLC
General Hospital · 123d
Cleared Jun 11, 2021
Medical Face Mask
K202714 · FXX
Chongqing Chaoke Industry Development...
General Hospital · 268d
Cleared Jun 11, 2021
EOS Air Cleaner
K202766 · FRA
Guangzhou Ajax Medical Equipment Co.,...
General Hospital · 263d
Cleared Jun 11, 2021
POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY...
K203030 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 252d
Cleared Jun 11, 2021
Radius T wearable thermometer
K203215 · FLL
Masimo Corporation
General Hospital · 221d
Cleared Jun 11, 2021
Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants
K203569 · NCB
Fci (France Chirurgie...
Ophthalmic · 186d
Cleared Jun 11, 2021
Surgical Face Mask
K203732 · FXX
Zhuhai Gaoge Medical Technology Co.,...
General Hospital · 172d
Cleared Jun 11, 2021
Replens Long-Lasting Vaginal Moisturizer
K203818 · NUC
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 164d
Cleared Jun 11, 2021
Axon Therapy
K210021 · QPL
Neuralace Medical, Inc.
Physical Medicine · 158d
Cleared Jun 11, 2021
LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System
K210484 · MXD
Medtronic, Inc.
Cardiovascular · 112d
Cleared Jun 11, 2021
Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
K210500 · IYE
Elekta Limited
Radiology · 109d
Cleared Jun 11, 2021
PANAVIA Veneer LC
K210504 · EMA
Kuraray Noritake Dental, Inc.
Dental · 109d
Cleared Jun 11, 2021
Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H
K210756 · NUH
Shenzhen Osto Technology Company Limited
Neurology · 88d
Cleared Jun 10, 2021
Spirometer
K201493 · BZG
Mehow Innovative, Ltd.
Anesthesiology · 371d
Cleared Jun 10, 2021
IDx-DR
K203629 · PIB
Digital Diagnostics, Inc.
Ophthalmic · 181d
Cleared Jun 10, 2021
Disposable Surgical Mask
K203756 · FXX
Lucky Textile Industrial(Wuxi) Co., Ltd.
General Hospital · 169d
Cleared Jun 10, 2021
Symmetric Total Knee System
K203779 · MBH
Signal Medical Corporation
Orthopedic · 164d
Cleared Jun 10, 2021
Surgical Face Mask
K210015 · FXX
Sample King Manufacturing, Ltd.
General Hospital · 157d
Cleared Jun 10, 2021
Blood Administration Set
K210335 · BRZ
Baxter Healthcare Corporation
General Hospital · 125d
Cleared Jun 10, 2021
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9...
K210416 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 119d