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
25417–25440 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 2018
Smartcord, Smartcord X
K171577 · MVL
Eastdent Co., Ltd.
Dental · 338d
Cleared May 03, 2018
PIEZOTOME CUBE
K172137 · DZI
Satelec - Acteon Group
Dental · 290d
Cleared May 03, 2018
Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7
K172777 · BSO
PAJUNK GmbH Medizintechnologie
Anesthesiology · 231d
Cleared May 03, 2018
Micropuncture Pedal Access Set
K172980 · DYB
Cook Incorporated
Cardiovascular · 218d
Cleared May 03, 2018
Brainsway Deep (DTMS) System
K173540 · OBP
Brainsway , Ltd.
Neurology · 169d
Cleared May 03, 2018
CAAS Workstation
K180019 · IZI
Pie Medical Imaging BV
Radiology · 121d
Cleared May 03, 2018
STYLO Interbody Fusion Device
K180071 · MAX
Legend Spine Technologies
Orthopedic · 114d
Cleared May 03, 2018
VivaScope System
K180162 · PSN
Caliber Imaging & Diagnostics, Inc.
General & Plastic Surgery · 104d
Cleared May 03, 2018
Repris Bladder Injection System
K180214 · FBK
Uro-1, Inc.
Gastroenterology & Urology · 98d
Cleared May 03, 2018
Indigo Aspiration System - Modified 110 Aspiration Tubing
K180939 · QEW
Penumbra, Inc.
Cardiovascular · 23d
Cleared May 03, 2018
Medtronic Confida Brecker Guidewire
K181001 · DQX
Medtronic Core Valve, LLC
Cardiovascular · 17d
Cleared May 02, 2018
Lite
K172409 · INI
Tzora Active Systems , Ltd.
Physical Medicine · 266d
Cleared May 02, 2018
Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with...
K172864 · LZC
Maxter Glove Manufacturing Sdn Bhd
General Hospital · 224d
Cleared May 02, 2018
Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit
K173653 · PGX
Alere Scarborough, Inc.
Microbiology · 155d
Cleared May 02, 2018
Accu O2 Oxygen Analyzer
K173807 · CCL
Precision Medical, Inc.
Anesthesiology · 138d
Cleared May 02, 2018
MC 300R* Nebulizer
K173825 · CAF
Trudell Medical International
Anesthesiology · 135d
Cleared May 02, 2018
Drug Relief
K173861 · PZR
Dyansys, Inc.
Neurology · 133d
Cleared May 02, 2018
ADAPT for Gamma3
K173946 · OLO
Stryker GmbH
Orthopedic · 126d
Cleared May 02, 2018
Cook 810 Set, Desilets-Hoffman Introducer Set
K180028 · EZN
Cook Incorporated
Gastroenterology & Urology · 119d
Cleared May 02, 2018
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
K180264 · LSR
Gold Standard Diagnostics
Microbiology · 92d
Cleared May 02, 2018
7D Surgical System
K180352 · OLO
7D Surgical, Inc.
Orthopedic · 83d
Cleared May 02, 2018
Venue
K180599 · IYN
GE Medical Systems Ultrasound and...
Radiology · 56d
Cleared May 02, 2018
Spineology Navigation Instruments
K180796 · OLO
Spineology, Inc.
Orthopedic · 36d
Cleared May 01, 2018
BacterioScan 216Dx System
K172412 · QBQ
Bacterioscan, Inc.
Microbiology · 264d