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
11473–11496 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 04, 2023
Radial Artery Compression Tourniquets
K222182 · DXC
Beijing Demax Medical Technology Co.,Ltd
Cardiovascular · 166d
Cleared Jan 04, 2023
DEKA HELIX
K222221 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 163d
Cleared Jan 04, 2023
Surgical Face Mask
K222483 · FXX
Hubei Woozon Healthcare Co., Ltd.
General Hospital · 140d
Cleared Jan 04, 2023
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
K222907 · LZA
Rmkh Glove (Cambodia) Co., Ltd.
General Hospital · 100d
Cleared Jan 04, 2023
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
K223411 · FYC
Xiamen Probtain Medical Techology...
General Hospital · 56d
Cleared Jan 04, 2023
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer
K223635 · JBP
Sienco, Inc.
Hematology · 30d
Cleared Jan 04, 2023
SmoothCool HR System
K223685 · GEX
Jeisys Medical, Inc.
General & Plastic Surgery · 26d
Cleared Jan 03, 2023
AETOS Shoulder System
K220847 · KWS
Smith & Nephew, Inc.
Orthopedic · 286d
Cleared Jan 03, 2023
Medical Disposable Face Masks
K222809 · FXX
Anqing Mayfield Medical Limited
General Hospital · 109d
Cleared Jan 03, 2023
3.0T 16ch AIR AA
K223378 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 57d
Cleared Jan 03, 2023
EZ-STIK Electrodes
K223775 · GXY
South Dakota Partners
Neurology · 18d
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