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
11209–11232 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 2022
EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter
K210313 · DRF
Shanghai Microport EP Medtech Co., Ltd.
Cardiovascular · 695d
Cleared Dec 30, 2022
CMFlexTM
K213260 · LYC
Dimension Inx Corp.
Dental · 456d
Cleared Dec 30, 2022
Fingertip Pulse Oximeter
K213430 · DQA
Shenzhen Witleaf Medical Electronics...
Anesthesiology · 435d
Cleared Dec 30, 2022
Aesculap AICON Container
K214041 · KCT
Aesculap, Inc.
General Hospital · 372d
Cleared Dec 30, 2022
Isolator® Linear Pen (MLP1)
K221358 · OCL
AtriCure, Inc.
Cardiovascular · 233d
Cleared Dec 30, 2022
Cyware 4H and Cysart 4H
K221796 · LLZ
Abys Medical
Radiology · 192d
Cleared Dec 30, 2022
Persyst 15 EEG Review and Analysis Software
K222002 · OMB
Persyst Development Corporation
Neurology · 176d
Cleared Dec 30, 2022
Biobeat Platform-2 and BB-613WP Patch
K222010 · DQA
Biobeat Technologies , Ltd.
Cardiovascular · 176d
Cleared Dec 30, 2022
aprevo® Digital Workflow
K222195 · LLZ
Carlsmed, Inc.
Radiology · 161d
Cleared Dec 30, 2022
PeekMed web (v1)
K222767 · LLZ
Peek Health, S.A.
Radiology · 108d
Cleared Dec 30, 2022
DNA Appliance
K222872 · LRK
Vivos Therapeutics, Inc.
Dental · 99d
Cleared Dec 30, 2022
ControlSeal Electrode (ELSB)
K223605 · GXY
Coapt
Neurology · 28d
Cleared Dec 30, 2022
Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
K223616 · ODG
Boston Scientific Corporation
Gastroenterology & Urology · 25d
Cleared Dec 30, 2022
X-ray Flat Panel Detectors (EverestView 4343X)
K223687 · MQB
Careray Digital Medical Technology...
Radiology · 21d
Cleared Dec 29, 2022
EndoPATx
K211557 · DQK
Itamar Medical , Ltd.
Cardiovascular · 589d
Cleared Dec 29, 2022
Multi-Parameter Patient Monitor
K211619 · MHX
Shenzhen Comen Medical Instruments...
Cardiovascular · 582d
Cleared Dec 29, 2022
Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical...
K220935 · FKX
Iren-Medical, Ltd.
Gastroenterology & Urology · 273d
Cleared Dec 29, 2022
Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional
K221333 · HWC
Acumed, LLC
Orthopedic · 234d
Cleared Dec 29, 2022
AG100s
K221477 · BSK
Hospitech Respiration , Ltd.
Anesthesiology · 220d
Cleared Dec 29, 2022
OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE...
K221690 · FAJ
Olympus Medical Systems Corp.
Gastroenterology & Urology · 202d
Cleared Dec 29, 2022
Atalante
K221859 · PHL
Wandercraft SAS
Neurology · 185d
Cleared Dec 29, 2022
SafeR Syringe and SafeR Sting
K221981 · MEG
Roncadelle Operations Srl
General Hospital · 177d
Cleared Dec 29, 2022
Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life...
K222528 · KPI
Well-Life Healthcare Limited
Gastroenterology & Urology · 129d
Cleared Dec 29, 2022
BioClean Implant Restorative System
K222984 · NHA
Bioclean Dental, LLC
Dental · 92d