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
5641–5664 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 2024
Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™...
K242393 · HQD
Acuity Polymers, Inc.
Ophthalmic · 80d
Cleared Nov 01, 2024
BD Vacutainer® One Use Holder
K242320 · JKA
Becton, Dickinson and Company
General Hospital · 88d
Cleared Nov 01, 2024
EXPERT - Flexible Joint Fixation System
K242311 · HTN
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 88d
Cleared Nov 01, 2024
SC+ Hemodialysis Device (SC-14269)
K242269 · ONW
Quanta Dialysis Technologies, Ltd.
Gastroenterology & Urology · 92d
Cleared Nov 01, 2024
VersaCross™ RF Wire
K242076 · DXF
Baylis Medical Company
Cardiovascular · 108d
Cleared Nov 01, 2024
Prophecy Surgical Planning System
K241999 · HSN
Wright Medical Technology, Inc....
Orthopedic · 115d
Cleared Nov 01, 2024
Affera Integrated Mapping System
K241828 · DQK
Medtronic, Inc.
Cardiovascular · 130d
Cleared Nov 01, 2024
ORTIV (ORTIV-BL, ORTIV-WH)
K241646 · GEX
Mvitro Co., Ltd.
General & Plastic Surgery · 147d
Cleared Nov 01, 2024
uDR 780i
K241068 · KPR
Shanghai United Imaging Healthcare...
Radiology · 196d
Cleared Nov 01, 2024
Signia™ Circular Adapter (Standard Length) (SIGCIRSTND)
K240881 · GAG
Covidien (Part of Medtronic)
General & Plastic Surgery · 214d
Cleared Nov 01, 2024
AMT Low-Profile Suprapubic Catheter & Drainage Set
K240514 · KOB
Applied Medical Technology, Inc.
Gastroenterology & Urology · 253d
Cleared Nov 01, 2024
Osteotomy Truss System (OTS)
K240388 · HRS
4Web Medical, Inc.
Orthopedic · 267d
Cleared Nov 01, 2024
EP•XT™ Unidirectional Steerable Diagnostic Catheter
K240366 · DRF
Boston Scientific Corporation
Cardiovascular · 269d
Cleared Oct 31, 2024
Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo
K243181 · FRO
Bionova Medical, Inc.
General & Plastic Surgery · 31d
Cleared Oct 31, 2024
Disposable Blood Pressure cuff
K242623 · DXQ
Shenzhen Medke Technology Co., Ltd.
Cardiovascular · 58d
Cleared Oct 31, 2024
Bonebridge Osteosynthesis Plating System
K242399 · HRS
Bonebridge AG
Orthopedic · 79d
Cleared Oct 31, 2024
PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim...
K242328 · LJT
Bard Access Systems, Inc.
General Hospital · 86d
Cleared Oct 31, 2024
eRAD PACS
K241223 · LLZ
Erad, Inc.
Radiology · 183d
Cleared Oct 31, 2024
SmartCardia 7L Platform (MCT)
K240653 · QYX
Smartcardia SA
Cardiovascular · 238d
Cleared Oct 31, 2024
BD Vacutainer® Citrate Blood Collection Tubes
K240455 · GIM
Becton, Dickinson and Company
Hematology · 259d
Cleared Oct 31, 2024
Highness Implant System
K240383 · DZE
Highness Co., Ltd.
Dental · 266d
Cleared Oct 31, 2024
V80 Anesthetic Vaporizer (V80)
K240375 · CAD
Shenzhen Mindray Bio-Medical...
Anesthesiology · 267d
Cleared Oct 30, 2024
Symbia Pro.specta Q3 (11364751)
K243186 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Oct 30, 2024
JOURNEY II Unicompartmental Knee System (JOURNEY II UK)
K242711 · HSX
Smith & Nephew, Inc.
Orthopedic · 51d