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
25393–25416 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 07, 2018
Endopath Electrosurgery Probe Plus II
K180031 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 123d
Cleared May 07, 2018
Weinmann Tracheostomy Exchange Set
K180034 · JOH
Cook Incorporated
Anesthesiology · 123d
Cleared May 07, 2018
Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs...
K180079 · BZQ
Hill-Rom, Inc.
Anesthesiology · 117d
Cleared May 07, 2018
Afinion HbA1c Dx
K180296 · PDJ
Alere Technologies AS
Chemistry · 94d
Cleared May 04, 2018
3.0 Dynamic TiBase
K162021 · NHA
Talladium Espana, SL
Dental · 652d
Cleared May 04, 2018
URIS OMNI System
K172100 · DZE
Truabutment, Inc.
Dental · 297d
Cleared May 04, 2018
Trackit T4 EEG Amplifier
K172271 · GWQ
Lifelines , Ltd.
Neurology · 280d
Cleared May 04, 2018
Cervage
K172568 · ODP
Precifit Medical, Ltd.
Orthopedic · 252d
Cleared May 04, 2018
Caldera Medical Transobturator Helical Introducer, Left
K172614 · PWJ
Caldera Medical, Inc.
Gastroenterology & Urology · 246d
Cleared May 04, 2018
TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System
K173345 · JIN
Taidoc Technology Corporation
Chemistry · 192d
Cleared May 04, 2018
g.Estim PRO
K173684 · GYC
G.Tec Medical Engineering GmbH
Neurology · 154d
Cleared May 04, 2018
Wallaby Avenir Coil System
K173711 · HCG
Wallaby Medical, Inc.
Neurology · 151d
Cleared May 04, 2018
StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO
K173874 · GAM
Origami Surgical, LLC
General & Plastic Surgery · 134d
Cleared May 04, 2018
NuVasive® XLX Interbody System
K173892 · MAX
Nu Vasive, Incorporated
Orthopedic · 134d
Cleared May 04, 2018
MEDRAD® Imaging Bulk Package Transfer Set
K173913 · PQH
Bayer U.S., LLC
General Hospital · 133d
Cleared May 04, 2018
QT ECG
K180157 · DXH
QT Medical, Inc.
Cardiovascular · 105d
Cleared May 04, 2018
Apollo TMS Therapy System
K180313 · OBP
Mag & More GmbH
Neurology · 88d
Cleared May 04, 2018
EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System,...
K180317 · MBH
Microport Orthopedics, Inc.
Orthopedic · 88d
Cleared May 04, 2018
Hexanium® TLIF
K180437 · MAX
Spinevision, S.A.S.
Orthopedic · 73d
Cleared May 04, 2018
Ulthera System
K180623 · OHV
Ulthera, Inc.
General & Plastic Surgery · 56d
Cleared May 04, 2018
Invenia ABUS Viewer
K180641 · LLZ
Ge Healthcare
Radiology · 53d
Cleared May 04, 2018
VitriGuard
K180740 · MQK
Origio A/S
Obstetrics & Gynecology · 43d
Cleared May 04, 2018
EVOL Spinal Interbody System, EVOS Lumbar Interbody System
K180891 · MAX
Cutting Edge Spine, LLC
Orthopedic · 29d
Cleared May 03, 2018
Fluorescence Mode
K171007 · NBL
Carl Zeiss Suzhou Co., Ltd.
Dental · 394d