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
5377–5400 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 2024
Socrates 38 Catheter
K242301 · QJP
Scientia Vascular, Inc.
Neurology · 124d
Cleared Dec 04, 2024
Rextar Pro
K242185 · EHD
Raypia Co., Ltd.
Radiology · 132d
Cleared Dec 04, 2024
Alcon 27GA Chandelier (8065000252)
K242184 · MPA
Alcon Laboratories, Inc.
Ophthalmic · 132d
Cleared Dec 04, 2024
DeepRhythmAI
K241197 · DQK
Medicalgorithmics S.A.
Cardiovascular · 218d
Cleared Dec 04, 2024
XBeam (v2)
K240671 · MUJ
Xstrahl, Ltd.
Radiology · 268d
Cleared Dec 03, 2024
Fix2Lock (PEEK Self Punching)
K243470 · MBI
Osteonic Co., Ltd.
Orthopedic · 25d
Cleared Dec 03, 2024
Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)
K243467 · MAI
Osteonic Co., Ltd.
Orthopedic · 25d
Cleared Dec 03, 2024
Verruca-Freeze H
K243454 · GEH
Cryosurgery, Inc.
General & Plastic Surgery · 26d
Cleared Dec 03, 2024
TrueLok Elevate
K242861 · KTT
Orthofix Srl
Orthopedic · 74d
Cleared Dec 03, 2024
ClearRead CT CAC
K242188 · JAK
Riverain Technologies, Inc.
Radiology · 131d
Cleared Dec 03, 2024
Sofsilk™ Coated Braided Silk Suture
K241486 · GAP
Covidien
General & Plastic Surgery · 193d
Cleared Dec 02, 2024
enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System
K243433 · FEB
STERIS Corporation
General Hospital · 27d
Cleared Dec 02, 2024
Riptide™ Aspiration Pump
K243418 · JCX
Micro Therapeutics, Inc. d/b/a ev3...
General & Plastic Surgery · 28d
Cleared Dec 02, 2024
GripMate
K243232 · KZH
Synthon Hispania S.L.
General Hospital · 54d
Cleared Dec 02, 2024
MIDASVu
K243020 · HRX
Intravu, Inc.
Orthopedic · 66d
Cleared Dec 02, 2024
GroWell BT Hair Growth System (GW10042)
K242619 · OAP
Apira Science, Inc.
General & Plastic Surgery · 90d
Cleared Dec 02, 2024
Philips IntelliSite Pathology Solution
K241871 · PSY
Philips Medical Systems Nederland B.V.
Pathology · 158d
Cleared Dec 02, 2024
Hintermann Series H2 Total Ankle System
K240475 · HSN
Vilex, LLC
Orthopedic · 286d
Cleared Dec 02, 2024
Ventoux VC2
K223120 · CBK
Flight Medical Innovations , Ltd.
Anesthesiology · 791d
Cleared Nov 29, 2024
Ruthless Spine RJB
K243375 · QWL
Ruthless, LLC Dba Ruthless Spine
Orthopedic · 30d
Cleared Nov 29, 2024
Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter
K242225 · NLH
Surgical Instrument Service and...
Cardiovascular · 123d
Cleared Nov 29, 2024
YO Home Sperm Test
K241628 · POV
Medical Electronic Systems , Ltd.
Hematology · 176d
Cleared Nov 29, 2024
Evie Med Ring
K241090 · DQA
Movano Inc. Dba Movano Health
Anesthesiology · 221d
Cleared Nov 27, 2024
KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)
K243409 · FBO
Karl Storz SE & CO. KG
Gastroenterology & Urology · 26d