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
10849–10872 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 17, 2023
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN...
K223466 · FGB
STERIS Corporation
Gastroenterology & Urology · 92d
Cleared Feb 17, 2023
Spectrum Saliva Collection Device
K223497 · QBD
Spectrum Solutions, LLC
Microbiology · 88d
Cleared Feb 17, 2023
APRO 70 Catheter and Alembic Aspiration Tubing
K223545 · NRY
Alembic, LLC
Neurology · 84d
Cleared Feb 17, 2023
Glidewell TuffSplint™ Appliance Resin
K223798 · MQC
Prismatik Dentalcraft, Inc.
Dental · 60d
Cleared Feb 17, 2023
EzDent-i / E2 / Prora View/ Smart M Viewer
K223820 · LLZ
Ewoosoft Co., Ltd.
Radiology · 58d
Cleared Feb 17, 2023
Excipio LV Thrombectomy Device
K223897 · QEW
Contego Medical, Inc.
Cardiovascular · 51d
Cleared Feb 16, 2023
Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker...
K212194 · HAW
Stryker Corporation
Neurology · 582d
Cleared Feb 16, 2023
Surgical Gown
K213844 · FYA
Bayteks Teknik Tekstil San. VE Tic. A.S.
General Hospital · 434d
Cleared Feb 16, 2023
Bambino 3, S3 and S3 Swing, U3 and U3 Light, X
K220698 · IOR
Panthera AB
Physical Medicine · 344d
Cleared Feb 16, 2023
Single-use Video Pancreaticobiliary Scope, PB Digital Controller
K221784 · FBN
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 240d
Cleared Feb 16, 2023
Passeo-35 Xeo Peripheral Dilatation Catheter
K222065 · LIT
Biotronik, Inc.
Cardiovascular · 218d
Cleared Feb 16, 2023
Disposable Infusion Bag for Parenteral Nutrition
K222622 · KPE
Beijing L&Z Medical Technology...
General Hospital · 169d
Cleared Feb 16, 2023
uMR 680
K222755 · LNH
Shanghai United Imaging Intelligence...
Radiology · 157d
Cleared Feb 16, 2023
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
K223028 · JAK
Shanghai United Imaging Healthcare...
Radiology · 140d
Cleared Feb 16, 2023
JAWS Nitinol Staple System
K223056 · JDR
Paragon 28, Inc.
Orthopedic · 139d
Cleared Feb 16, 2023
Sterile Aesthetic Cannula and Hypodermic Needle
K223327 · FMI
Shanghai Kindly Enterprise...
General Hospital · 108d
Cleared Feb 16, 2023
PMMA Blocks for Dental Use
K223477 · EBG
Aidite (Qinhuangdao) Technology Co.,...
Dental · 90d
Cleared Feb 16, 2023
VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL)
K223478 · LON
bioMerieux, Inc.
Microbiology · 90d
Cleared Feb 16, 2023
IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03
K223524 · OHT
Morlaser Shenzhen Co., Ltd.
General & Plastic Surgery · 85d
Cleared Feb 16, 2023
CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4
K223733 · DQK
Biosense Webster, Inc.
Cardiovascular · 65d
Cleared Feb 16, 2023
NUVISION™ NAV Ultrasound Catheter
K223766 · OBJ
Biosense Webster, Inc.
Cardiovascular · 63d
Cleared Feb 16, 2023
Sonopet 1Q 3 7cm 1Q Large
K223770 · LFL
Stryker Corporation
General & Plastic Surgery · 63d
Cleared Feb 16, 2023
Vivid S60N, Vivid S70N
K223832 · IYN
Ge Medical System Ultrasound and...
Radiology · 56d
Cleared Feb 16, 2023
Bony Trauma Extremity System (BTES) Screw Range, NX Nail
K230118 · HWC
Field Orthopaedics Pty, Ltd.
Orthopedic · 30d