FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
12289–12312 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 2022
Disposable Endoscope Valves System
K221331 · ODC
Changzhou Endoclean Medical Device...
Gastroenterology & Urology · 126d
Cleared Sep 08, 2022
Osstem Abutment System
K221684 · NHA
Osstem Implant Co., Ltd.
Dental · 90d
Cleared Sep 08, 2022
HD-550 Video Endoscope System
K222020 · NWB
Sonoscape Medical Corp.
Gastroenterology & Urology · 62d
Cleared Sep 08, 2022
EFAI ChestSuite XR Pleural Effusion Assessment System
K222076 · QFM
Ever Fortune.Ai, Co., Ltd.
Radiology · 56d
Cleared Sep 08, 2022
CAPTIVATE® Compression Screws
K222409 · HWC
Globus Medical, Inc.
Orthopedic · 29d
Cleared Sep 08, 2022
Ellusa Reusable Neutral Plates
K222425 · GEI
Ellusa, LLC
General & Plastic Surgery · 28d
Cleared Sep 07, 2022
EyeCTester
K203594 · QTW
Neuro-Eye Diagnostic Systems, LLC
Ophthalmic · 637d
Cleared Sep 07, 2022
AXIOS Stent and Electrocautery-Enhanced Delivery System
K220112 · PCU
Boston Scientific Corporation
Gastroenterology & Urology · 237d
Cleared Sep 07, 2022
Easi-Vue embolic microspheres System
K220567 · KRD
Abk Biomedical, Inc.
Cardiovascular · 191d
Cleared Sep 07, 2022
syngo.via RT Image Suite
K220783 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 174d
Cleared Sep 07, 2022
Matreneu Percutaneous Balloon Compression Kit
K220920 · HAO
Shenzhen Shineyard Medical Device Co....
Neurology · 161d
Cleared Sep 07, 2022
FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire,...
K221731 · MBI
T.A.G. Medical Products Corporation,...
Orthopedic · 84d
Cleared Sep 07, 2022
RightLance Blood Lancing System
K222034 · QRL
Beijing Ruicheng Medical Supplies...
General & Plastic Surgery · 58d
Cleared Sep 07, 2022
Mariner RDX System
K222110 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 51d
Cleared Sep 07, 2022
Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G
K222111 · FMK
Owen Mumford, Ltd.
General & Plastic Surgery · 51d
Cleared Sep 06, 2022
TULSA-PRO System
K211858 · PLP
Profound Medical, Inc.
Gastroenterology & Urology · 447d
Cleared Sep 06, 2022
ASAHI Gladius Mongo18 PV ES
K213868 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 270d
Cleared Sep 06, 2022
LiverMultiScan v5 (LMSv5)
K213960 · LNH
Perspectum
Radiology · 263d
Cleared Sep 06, 2022
Neodent Implant System - GM Narrow Implant System
K220251 · DZE
Jjgc Industria E Comercio DE...
Dental · 218d
Cleared Sep 06, 2022
ROTAPRO Rotational Atherectomy System
K220962 · MCW
Boston Scientific Corporation
Cardiovascular · 158d
Cleared Sep 06, 2022
Hammertoe Truss System (HTS)
K221283 · HTY
4Web Medical, Inc.
Orthopedic · 126d
Cleared Sep 06, 2022
EMPHASYS Acetabular System
K221636 · LPH
Depuy Ireland UC
Orthopedic · 92d
Cleared Sep 06, 2022
Smith+Nephew INTELLIO Tablet
K221929 · ODA
Smith & Nephew
General & Plastic Surgery · 67d
Cleared Sep 06, 2022
Spectrum IQ Infusion System with Dose IQ Safety Software
K222048 · FRN
Baxter Healthcare Corporation
General Hospital · 56d