FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
19993–20016 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 26, 2020
GentleMax Pro Plus
K201111 · GEX
Candela Corporation
General & Plastic Surgery · 29d
Cleared May 26, 2020
Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level,...
K201118 · GWM
Medtronic, Inc.
Neurology · 29d
Cleared May 26, 2020
ACUSON Juniper Diagnostic Ultrasound System
K201130 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared May 22, 2020
SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports
K190559 · LJT
AngioDynamics, Inc.
General Hospital · 444d
Cleared May 22, 2020
Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use...
K191847 · GEI
Adeor Medical AG
General & Plastic Surgery · 317d
Cleared May 22, 2020
CO2 Sidestream Module
K192488 · CCK
Beijing Kingst Commercial & Trade...
Anesthesiology · 254d
Cleared May 22, 2020
Surgical Gown
K192560 · FYA
Shandong Kangli Medical Equipment...
General Hospital · 248d
Cleared May 22, 2020
VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0
K193423 · NKB
Icotec AG
Orthopedic · 165d
Cleared May 22, 2020
VERIFY Assert Self-Contained Biological Indicator
K200126 · FRC
STERIS Corporation
General Hospital · 122d
Cleared May 22, 2020
JPS JuniOrtho Plating System
K200246 · HRS
Orthofix Srl
Orthopedic · 112d
Cleared May 22, 2020
Reconnaissance PV .018 OTW Digital IVUS Catheter
K200410 · OBJ
Philips Image Guided Therapy Corporation
Cardiovascular · 93d
Cleared May 22, 2020
Kalera Vacuum Aspiration Catheter (K-VAC)
K200419 · FED
Kalera Medical, Inc.
Gastroenterology & Urology · 92d
Cleared May 22, 2020
Premium Warming Personal Lubricant, Premium Anal Warming Lubricant,...
K200457 · NUC
CC Wellness, LLC
Obstetrics & Gynecology · 87d
Cleared May 22, 2020
Invictus™ CT Spinal Fixation System
K200936 · NKG
Alphatec Spine, Inc.
Orthopedic · 44d
Cleared May 21, 2020
LotusCatheter (Lotus No Balloon Catheter)
K191512 · GBM
Hakki Medical Technologies, Inc.
Gastroenterology & Urology · 349d
Cleared May 21, 2020
gi-4000 Electrosurgical Generator
K192265 · GEI
United States Endoscopy Group, Inc.
General & Plastic Surgery · 274d
Cleared May 21, 2020
Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy...
K192342 · KNS
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 267d
Cleared May 21, 2020
CO2 Mainstream Module
K192446 · CCK
Beijing Kingst Commercial & Trade...
Anesthesiology · 258d
Cleared May 21, 2020
Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic...
K192879 · IYN
Edan Instruments, Inc.
Radiology · 234d
Cleared May 21, 2020
BeneVision Central Monitoring System
K193391 · MSX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 167d
Cleared May 21, 2020
Getinge Assured MI Steam Migrating Integrator
K200252 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 108d
Cleared May 21, 2020
CariCloud
K200274 · LLZ
Caristo Diagnostics
Radiology · 107d
Cleared May 21, 2020
Systane iLux2
K200400 · ORZ
Tear Film Innovations, Inc.
Ophthalmic · 93d
Cleared May 21, 2020
V30 system, V20 system, V10 system, V-FC Handpiece
K200468 · PBX
Viora , Ltd.
General & Plastic Surgery · 85d