FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
10753–10776 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 2023
SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser
K222485 · GEX
Ids, Limited
General & Plastic Surgery · 224d
Cleared Mar 29, 2023
Stethophone v1
K222871 · DQD
Sparrow Acoustics, Inc.
Cardiovascular · 188d
Cleared Mar 29, 2023
Trevo NXT ProVue Retriever
K223305 · POL
Stryker Neurovascular
Neurology · 153d
Cleared Mar 29, 2023
Calibrate LTX Interbody System
K223611 · MAX
Alphatec Spine, Inc.
Orthopedic · 117d
Cleared Mar 29, 2023
Tactoset
K223915 · MQV
Anika Therapeutics, Inc.
Orthopedic · 90d
Cleared Mar 29, 2023
PUMA-G System
K223916 · KGC
Coaptech, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 29, 2023
ROSA® Knee System
K230243 · OLO
Orthosoft D/B/A Zimmer Cas
Orthopedic · 58d
Cleared Mar 29, 2023
WishBone Medical Plate and Screw System
K230527 · HRS
Wishbone Medical, Inc.
Orthopedic · 30d
Cleared Mar 28, 2023
Carestation 750/750c
K213867 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 473d
Cleared Mar 28, 2023
X-Y Lubricating Jelly
K220226 · NUC
R&R Medical Corporation, Ltd.
Obstetrics & Gynecology · 425d
Cleared Mar 28, 2023
DTX Studio Clinic 3.0
K221921 · MYN
Nobel Biocare AB
Radiology · 270d
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