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
9577–9600 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 2023
AusculThing ACC
K230823 · DQD
Ausculthing OY
Cardiovascular · 110d
Cleared Jul 12, 2023
RADx Intraoral Appliance for Snoring and Sleep Apnea
K230532 · LQZ
Achaemenid, LLC
Dental · 135d
Cleared Jul 12, 2023
Zavation Navigation Instrument System
K223808 · OLO
Zavation Medical Products, LLC
Orthopedic · 204d
Cleared Jul 12, 2023
Comprehensive Segmental Revision System(SRS)
K223631 · KWT
Biomet Orthopedics
Orthopedic · 219d
Cleared Jul 11, 2023
MINIMA S System
K231925 · LZO
Lima Corporate S.P.A.
Orthopedic · 11d
Cleared Jul 11, 2023
NuVasive CoRoent Small Interbody System
K231735 · ODP
Nu Vasive, Incorporated
Orthopedic · 27d
Cleared Jul 11, 2023
microINR System
K231711 · GJS
Iline Microsystems, S.L.
Hematology · 29d
Cleared Jul 11, 2023
Bonalive Orthopedics granules
K231528 · MQV
Bonalive Biomaterials, Ltd.
Orthopedic · 46d
Cleared Jul 11, 2023
Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste
K231386 · MTJ
Orthocon, Inc.
Orthopedic · 60d
Cleared Jul 11, 2023
SPIRA® Posterior Lumbar Spacers
K230942 · MAX
Camber Spine Technologies
Orthopedic · 99d
Cleared Jul 11, 2023
Anthogyr Surgical Cassettes
K230680 · KCT
Anthogyr
General Hospital · 120d
Cleared Jul 11, 2023
CUSA Clarity Ultrasonic Surgical Aspirator System
K230427 · LFL
Integra LifeSciences Corporation
General & Plastic Surgery · 144d
Cleared Jul 11, 2023
Dentis i-Clean System
K230307 · NHA
Dentis Co., Ltd.
Dental · 158d
Cleared Jul 11, 2023
Play and Joy Water-Based Lubricant
K221137 · NUC
Innovemed Bio-Tech Co., Ltd.
Obstetrics & Gynecology · 448d
Cleared Jul 10, 2023
Ziehm Vision RFD 3D
K231701 · OWB
Ziehm Imaging GmbH
Radiology · 28d
Cleared Jul 10, 2023
CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S,...
K231412 · DYB
Biosense Webster, Inc.
Cardiovascular · 55d
Cleared Jul 10, 2023
Endofill
K231387 · KIF
Lumendo AG
Dental · 59d
Cleared Jul 10, 2023
PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter,...
K231312 · MTD
Biosense Webster, Inc.
Cardiovascular · 66d
Cleared Jul 10, 2023
AcQMap High Resolution Imaging and Mapping System
K231091 · DQK
Acutus Medical, Inc.
Cardiovascular · 84d
Cleared Jul 10, 2023
MOZI TPS
K223724 · MUJ
Manteia Technologies Co., Ltd.
Radiology · 209d
Cleared Jul 10, 2023
EnteraLoc Flow
K223683 · PIF
Vonco Products
Gastroenterology & Urology · 214d
Cleared Jul 10, 2023
Tandem Mobi Insulin Pump with Interoperable Technology
K223213 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 266d
Cleared Jul 10, 2023
X-View 3D Pan/X-View 2D Pan
K222666 · OAS
Trident S.R.L
Radiology · 307d
Cleared Jul 10, 2023
Edge Upper Cervical System
K221307 · NKG
Spinal Simplicity, LLC
Orthopedic · 431d