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
12865–12888 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 2022
Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105,...
K221170 · FLL
Shenzhen AOJ Medical Technology Co.,...
General Hospital · 168d
Cleared Oct 07, 2022
Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing
K221310 · OCX
Changzhou Endoclean Medical Device...
Gastroenterology & Urology · 155d
Cleared Oct 07, 2022
SteriTite Container System with MediTray Parts
K221492 · KCT
Case Medical, Inc.
General Hospital · 137d
Cleared Oct 07, 2022
Miha Bodytec II
K221498 · NGX
Miha Bodytec GmbH
Physical Medicine · 137d
Cleared Oct 07, 2022
Pre-Formed Blue
K221575 · DQX
Lake Region Medical
Cardiovascular · 128d
Cleared Oct 07, 2022
InBody Blood pressure monitor, Model BPBIO480KV
K221764 · DXN
Inbody Co., Ltd.
Cardiovascular · 112d
Cleared Oct 07, 2022
Rebellion
K221818 · HAE
Morpheus AG
Neurology · 106d
Cleared Oct 07, 2022
IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System,...
K222028 · MAX
Alphatec Spine
Orthopedic · 88d
Cleared Oct 07, 2022
Cold Sore Device (Model: QPZ-01)
K222205 · OKJ
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 74d
Cleared Oct 07, 2022
PURE Laser
K222369 · GEX
Endymed Medical, Ltd.
General & Plastic Surgery · 63d
Cleared Oct 07, 2022
Nuvola
K222418 · NXC
Gruppo Europeo Ortodonzia Srl
Dental · 58d
Cleared Oct 07, 2022
Protect-It Custom Fit Dental Guard
K222424 · OBR
Doc Brands, Inc.
Dental · 57d
Cleared Oct 07, 2022
CUVIS-spine
K222698 · OLO
Curexo, Inc.
Orthopedic · 30d
Cleared Oct 07, 2022
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy...
K222714 · LZA
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 29d
Cleared Oct 06, 2022
ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)
K211892 · MQP
Arftx Medical, LLC
Orthopedic · 472d
Cleared Oct 06, 2022
A&D Medical UM-212BLE Blood Pressure Monitor
K212168 · DXN
A&D Company, Ltd.
Cardiovascular · 451d
Cleared Oct 06, 2022
NuCath Wedge Pressure Catheter
K213666 · DQO
Pfm Medical, Inc.
Cardiovascular · 318d
Cleared Oct 06, 2022
Gemini Sterilization Wrap
K220365 · FRG
Medline Industries, LP
General Hospital · 240d
Cleared Oct 06, 2022
iCare IC200
K220852 · HKY
Icare Finland OY
Ophthalmic · 197d
Cleared Oct 06, 2022
Genius AI Detection 2.0
K221449 · QDQ
Hologic, Inc.
Radiology · 141d
Cleared Oct 06, 2022
InfaTherm Disposable Infant Warming Mattress
K221653 · IMD
International Biomedical
Physical Medicine · 121d
Cleared Oct 06, 2022
ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore...
K221889 · LRK
Prosomnus Sleep Technologies
Dental · 99d
Cleared Oct 06, 2022
Garion Image-Intensified Fluoroscopic X-Ray System, Mobile
K222080 · OWB
Sg Healthcare Co, Ltd.
Radiology · 83d
Cleared Oct 06, 2022
PRIMA TT Glenoid
K222427 · MBF
Lima Corporate S.P.A.
Orthopedic · 56d