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
10489–10512 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 2023
KLS Martin Pure Pectus System
K221938 · HRS
KLS-Martin L.P.
Orthopedic · 270d
Cleared Mar 28, 2023
Gas Insufflator
K221995 · HIF
Surgnova Healthcare Technologies...
Obstetrics & Gynecology · 265d
Cleared Mar 28, 2023
Disposable Endoscopic Hemoclip
K222146 · PKL
Jiangsu Vedkang Medical Science and...
Gastroenterology & Urology · 251d
Cleared Mar 28, 2023
RadioLens v1.0
K222174 · QIH
Synapsica
Radiology · 250d
Cleared Mar 28, 2023
Annalise Enterprise CXR Triage Trauma
K222179 · QFM
Annalise-Ai Pty , Ltd.
Radiology · 249d
Cleared Mar 28, 2023
Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500
K222260 · PBX
Capenergy Medical S.L.
General & Plastic Surgery · 243d
Cleared Mar 28, 2023
Annalise Enterprise CXR Triage Trauma
K222268 · QFM
Annalise-Ai Pty , Ltd.
Radiology · 243d
Cleared Mar 28, 2023
Electrical Scooter, WT-T4QP2
K222729 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 201d
Cleared Mar 28, 2023
MAGNETOM Amira
K223343 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 147d
Cleared Mar 28, 2023
CapnoSpot™ Pneumothorax Decompression Indicator
K223625 · GAA
Pneumeric, Inc.
General & Plastic Surgery · 113d
Cleared Mar 28, 2023
Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D,...
K223928 · OHT
Shenzhen Fansizhe Science And...
General & Plastic Surgery · 88d
Cleared Mar 28, 2023
SQUALE
K230026 · ODP
Implanet, S.A.
Orthopedic · 83d
Cleared Mar 28, 2023
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
K230251 · NUJ
Stryker Sustainability Solutions
General & Plastic Surgery · 57d
Cleared Mar 28, 2023
Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019
K230255 · GEI
Stryker Sustainability Solutions
General & Plastic Surgery · 56d
Cleared Mar 28, 2023
ISOLIS Cryoprobe
K230271 · GEH
Varian Medical Systems, Inc.
General & Plastic Surgery · 56d
Cleared Mar 28, 2023
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
K230582 · MED
STERIS Corporation
General Hospital · 26d
Cleared Mar 27, 2023
Meril-Bonewax
K200452 · MTJ
M/s. Meril Endo Surgery Private Limited.
Orthopedic · 1127d
Cleared Mar 27, 2023
Overjet Caries Assist
K222746 · MYN
Overjet, Inc.
Radiology · 196d
Cleared Mar 27, 2023
XT Stain/Glaze
K223192 · EIH
Shenzhen Xiangtong Co., Ltd.
Dental · 165d
Cleared Mar 27, 2023
RODIN Palette Naturalizing Kit
K223365 · EBD
Belport Company, Inc., Gingi-Pak
Dental · 144d
Cleared Mar 27, 2023
Solero Microwave Tissue Ablation (MTA) System and Accessories
K223581 · NEY
AngioDynamics, Inc.
General & Plastic Surgery · 116d
Cleared Mar 27, 2023
Disposable Surgical Face Mask
K223823 · FXX
Efofex, Inc.
General Hospital · 96d
Cleared Mar 27, 2023
Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)
K223882 · FTC
Shenzhen Honpal Optoelectronic...
General & Plastic Surgery · 90d
Cleared Mar 25, 2023
Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use,...
K220644 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 386d