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
4465–4488 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 2025
MagnetOs MIS
K243474 · MQV
Kuros Biosciences B.V
Orthopedic · 196d
Cleared May 23, 2025
FUJIFILM Endoscope Model EC-860P/M
K243261 · FDF
Fujifilm Corporation
Gastroenterology & Urology · 220d
Cleared May 23, 2025
WiZARD 520 Full Face Mask
K243023 · BZD
Wellell, Inc.
Anesthesiology · 238d
Cleared May 23, 2025
DEEPECHO
K242594 · IYN
Deepecho
Radiology · 266d
Cleared May 23, 2025
Stereotaxic Guiding Surgical Devices, NaoTrac S
K242575 · HAW
Brain Navi Biotechnology Co., Ltd.
Neurology · 267d
Cleared May 23, 2025
RadiForce MX317W-PA
K242545 · PZZ
Eizo Corporation
Pathology · 269d
Cleared May 22, 2025
Skin Clinic Freeze Point for Warts and Skin Tags
K251493 · GEH
Cryoconcepts LP
General & Plastic Surgery · 7d
Cleared May 22, 2025
Trivicta® Hip Stem
K251052 · MEH
Ortho Development Corp.
Orthopedic · 49d
Cleared May 22, 2025
Physica System (Physica CR Porous Femoral components)
K250980 · MBH
Lima Corporate S.P.A.
Orthopedic · 52d
Cleared May 22, 2025
TriMed Fifth Metatarsal System (Fifth Metatarsal Plate)
K250935 · HRS
TriMed, Inc.
Orthopedic · 55d
Cleared May 22, 2025
Arthrex Spine Compression FT Screw
K250920 · MRW
Arthrex, Inc.
Orthopedic · 56d
Cleared May 22, 2025
Optilume® High Pressure Urological Balloon Dilation Catheter
K250910 · EZN
Urotronic, Inc.
Gastroenterology & Urology · 57d
Cleared May 22, 2025
Koala Intrauterine Pressure Catheter (IPC-5000E)
K250897 · HFN
Clinical Innovations, LLC
Obstetrics & Gynecology · 58d
Cleared May 22, 2025
YUWELL® Infrared Ear Thermometer (YHT100)
K250878 · FLL
Jiangsu Yuyue Medical Equipment&...
General Hospital · 59d
Cleared May 22, 2025
DESS Dental Smart Solutions
K250639 · NHA
Terrats Medical SL
Dental · 80d
Cleared May 22, 2025
Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with...
K250630 · LZA
Basic Medical Technology, Inc.
General Hospital · 80d
Cleared May 22, 2025
Solawave 2-in-1 Skincare Mini (Model: 61043)
K250532 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 87d
Cleared May 22, 2025
Harioculture TL-16 Time-lapse Incubator
K242684 · MQG
Hua Yue Medical Technology Co., Ltd.
Obstetrics & Gynecology · 258d
Cleared May 22, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K242659 · JWY
Thermo Fisher Scientific
Microbiology · 260d
Cleared May 22, 2025
ArgoCap (200.52)
K242586 · OCX
Ovesco Endoscopy AG
Gastroenterology & Urology · 265d
Cleared May 21, 2025
Swoop® Portable MR Imaging® System
K251276 · LNH
Hyperfine, Inc.
Radiology · 27d
Cleared May 21, 2025
GrandioSO Unlimited
K251239 · EBF
Voco GmbH
Dental · 29d
Cleared May 21, 2025
The Alma Hybrid Laser System
K251230 · GEX
Alma Lasers, Inc.
General & Plastic Surgery · 30d
Cleared May 21, 2025
SMARTDent
K251109 · LLZ
Ray Co., Ltd.
Radiology · 40d