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
19561–19584 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 2020
Visera Elite II Video System Center
K201200 · FET
Olympus Medical Systems Corp.
Obstetrics & Gynecology · 79d
Cleared Jul 22, 2020
Endomat Select, IBS Shaver Software, License
K201355 · HIG
Karl Storz SE & CO. KG
Obstetrics & Gynecology · 62d
Cleared Jul 22, 2020
Picowon
K201406 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 55d
Cleared Jul 22, 2020
EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)
K201527 · HRS
Smith & Nephew, Inc.
Orthopedic · 44d
Cleared Jul 22, 2020
Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor
K201699 · NLF
Surgical Instrument and Savings Inc...
Anesthesiology · 30d
Cleared Jul 22, 2020
Pedicle Screw System
K201751 · NKB
Black Box Medical, LLC
Orthopedic · 26d
Cleared Jul 22, 2020
True Tulip System, True M.I.S. System
K201780 · NKB
Innovative Surgical Designs, Inc.
Orthopedic · 22d
Cleared Jul 21, 2020
AUTOLIGN
K192847 · PNN
Diorco Co., Ltd.
Dental · 292d
Cleared Jul 21, 2020
VITA LUMEX AC
K193434 · EIH
Vita Zahnfabrik GmbH H Rauter & CO
Dental · 223d
Cleared Jul 21, 2020
BOBBY Balloon Guide Catheter
K193607 · DQY
MicroVention, Inc.
Neurology · 208d
Cleared Jul 21, 2020
Wiggins Medical Surgical Instruments
K200383 · HAE
Wiggins Medical
Neurology · 154d
Cleared Jul 21, 2020
Ace Medical Surgical Instruments
K200387 · HAE
Ace Medical
Neurology · 154d
Cleared Jul 21, 2020
Riptide Aspiration System
K201689 · NRY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 29d
Cleared Jul 21, 2020
Mirage Hydrophilic Guidewire
K201690 · DQX
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 29d
Cleared Jul 20, 2020
Owgels Oxygen Concentrator
K191875 · CAW
Guangzhou Life Light Electronic...
Anesthesiology · 374d
Cleared Jul 20, 2020
Intravascular Extension Sets and Accessories
K192366 · FPA
Baxter Healthcare Corporation
General Hospital · 325d
Cleared Jul 20, 2020
Retractable Safety Insulin Syringe
K193022 · MEG
Jiangsu Caina Medical Co.,Ltd
General Hospital · 264d
Cleared Jul 20, 2020
CERENOVUS Large Bore Catheter
K193380 · NRY
Codman & Shurtleff, Inc.
Neurology · 228d
Cleared Jul 20, 2020
BioSiCar Silicone Implant
K193392 · MIB
Metalware Technology Corp.
General & Plastic Surgery · 227d
Cleared Jul 20, 2020
Benesta Medical Sterilization Tray
K193603 · KCT
Caldera Medical, Inc.
General Hospital · 210d
Cleared Jul 20, 2020
GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable
K201179 · DQA
Covidien, LLC
Anesthesiology · 80d
Cleared Jul 20, 2020
Smith+Nephew Arthroscopes
K201349 · HRX
Smith & Nephew
Orthopedic · 60d
Cleared Jul 17, 2020
Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III...
K192793 · FDF
Olympus Medical Systems Corp.
Gastroenterology & Urology · 291d
Cleared Jul 17, 2020
Cryocheck Chromogenic Factor VIII
K193204 · GGP
Precision Biologic
Hematology · 240d