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
8089–8112 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 2023
fMRI Hardware System
K232680 · LNH
Nordicneurolab AS
Radiology · 103d
Cleared Dec 13, 2023
Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup
K232659 · DJG
Guangzhou Decheng Biotechnology Co.,...
Toxicology · 104d
Cleared Dec 13, 2023
Anatomical Plating System (various)
K232652 · HRS
Tyber Medical, LLC
Orthopedic · 104d
Cleared Dec 13, 2023
Kalitec Navigated Instrument System
K232572 · OLO
Kalitec Direct, LLC Doing Business AS...
Orthopedic · 111d
Cleared Dec 13, 2023
Tyto Insights for Wheeze Detection
K232237 · PHZ
Tyto Care , Ltd.
Anesthesiology · 138d
Cleared Dec 13, 2023
QP-Brain®
K232231 · QIH
Quibim S.L.
Radiology · 139d
Cleared Dec 13, 2023
Atalante X
K232077 · PHL
Wandercraft SAS
Neurology · 153d
Cleared Dec 13, 2023
SaliPen
K232063 · QTT
Saliwell , Ltd.
Dental · 155d
Cleared Dec 13, 2023
CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System
K231870 · DQK
Ge Medical Systems Information...
Cardiovascular · 170d
Cleared Dec 13, 2023
Neodent Implant System - Zirconia Implant System
K231803 · NHA
JJGC Ind?stria e Com?rcio de...
Dental · 176d
Cleared Dec 13, 2023
Endoscopic Ultrasonic Probe (P2612S-L)
K231666 · ITX
Fujifilm Healthcare Americas Corporation
Radiology · 189d
Cleared Dec 13, 2023
MiroTract Wound Matrix
K231614 · KGN
Reprise Biomedical, Inc.
General & Plastic Surgery · 194d
Cleared Dec 13, 2023
EndeavorRx
K231337 · QFT
Akili Interactive Labs, Inc.
Neurology · 219d
Cleared Dec 13, 2023
CLEARFIL Universal Bond Quick 2
K231039 · KLE
Kuraray Noritake Dental, Inc.
Dental · 245d
Cleared Dec 13, 2023
Power Wheelchair (N5909)
K230964 · ITI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 252d
Cleared Dec 13, 2023
HemosIL Chromogenic Factor IX
K230852 · GGP
Instrumentation Laboratory Company
Hematology · 260d
Cleared Dec 13, 2023
ACCLARENT AERA Eustachian Tube Dilation System
K230742 · PNZ
Acclarent, Inc.
Ear, Nose, Throat · 271d
Cleared Dec 12, 2023
TriALTIS™ Spine System
K233684 · NKB
Medos International SARL
Orthopedic · 26d
Cleared Dec 12, 2023
Intri24 Introducer Sheath (52-101)
K233646 · DYB
Inari Medical, Inc.
Cardiovascular · 28d
Cleared Dec 12, 2023
StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue...
K233645 · FGB
Boston Scientific Corporation
Gastroenterology & Urology · 28d
Cleared Dec 12, 2023
TeleScan
K233634 · LLZ
Bb Imaging
Radiology · 29d
Cleared Dec 12, 2023
ARx MIS Spinal Screw System
K233455 · NKB
Life Spine, Inc.
Orthopedic · 53d
Cleared Dec 12, 2023
Aygün Sterilization Container Systems
K233222 · KCT
Aygun Surgical Instruments Co., Inc.
General Hospital · 75d
Cleared Dec 12, 2023
Sterile Hypodermic Needles for Single Use
K233037 · FMI
Zhejiang Kindly Medical Device Co., Ltd.
General Hospital · 78d