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
34729–34752 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 2015
LC CALCIUMHYDROXIDE LINER
K141047 · EJK
S&C Polymer Silicon- Und Composite...
Dental · 356d
Cleared Apr 14, 2015
HONGYU DISPOSABLE SURGICAL DRAPES
K141324 · KKX
Weihai Hongyu Nonwoven Fabric...
General Hospital · 329d
Cleared Apr 14, 2015
LX-100 Hair Growth Stimulation System
K142824 · OAP
Hairlabs International, Inc.
General & Plastic Surgery · 196d
Cleared Apr 14, 2015
Acrylic Block
K143265 · EBI
Sun Medical Co., Ltd.
Dental · 152d
Cleared Apr 14, 2015
Delivery Analysis
K143269 · MUJ
Accuray Incorporated
Radiology · 152d
Cleared Apr 14, 2015
Fast Sphyg by Koven
K143332 · DXQ
Koven Technology, Inc.
Cardiovascular · 145d
Cleared Apr 14, 2015
Revital-Ox RESERT Solution Test Strip
K143333 · JOJ
STERIS Corporation
General Hospital · 145d
Cleared Apr 14, 2015
HeartSee
K143664 · KPS
University of Texas Medical School AT...
Radiology · 112d
Cleared Apr 14, 2015
IMPLANET Spine System (ISS)
K143731 · NKB
Implanet, S.A.
Orthopedic · 106d
Cleared Apr 14, 2015
MicroCross Catheter
K143744 · DQY
Roxwood Medical, Inc.
Cardiovascular · 104d
Cleared Apr 14, 2015
TheyFit Male Condom
K150072 · HIS
Theyfit
Obstetrics & Gynecology · 90d
Cleared Apr 14, 2015
Sidecar External Working Channel
K150083 · FED
C2 Therapeutics
Gastroenterology & Urology · 89d
Cleared Apr 14, 2015
JUSHA-M52C Medical Display
K150746 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 22d
Cleared Apr 13, 2015
Monopolar Laparascopic Accessories
K142208 · GEI
Unimicro Medical Systems (Shenzhen)...
General & Plastic Surgery · 245d
Cleared Apr 13, 2015
PINPOINT GT SAFETY INTRODUCER NEEDLE
K142445 · DYB
C.R. Bard, Inc.
Cardiovascular · 223d
Cleared Apr 13, 2015
Lubricating Jelly
K142473 · KMJ
Sion Biotext Medical , Ltd.
General Hospital · 222d
Cleared Apr 13, 2015
mint Lesion
K142647 · LLZ
Mint Medical GmbH
Radiology · 208d
Cleared Apr 13, 2015
Pulse Oximeter
K142687 · DQA
Shanghai Berry Electronic Tech Co., Ltd.
Anesthesiology · 203d
Cleared Apr 13, 2015
MDT Navigable Brain Biopsy Cannula
K143241 · HAW
Izi Medical Products, LLC
Neurology · 152d
Cleared Apr 13, 2015
Neoss Ti Reinforced Membrane
K143327 · NPK
Neoss, Ltd.
Dental · 144d
Cleared Apr 13, 2015
SoundCure Serenade Tinnitus Treatment System
K150065 · KLW
Soundcure, Inc.
Ear, Nose, Throat · 90d
Cleared Apr 13, 2015
IMMULITE IGF Control Module, IMMULITE Gastrin Control Module
K150132 · JJX
Siemens Healthcare Diagnostics
Chemistry · 82d
Cleared Apr 13, 2015
DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS
K150516 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 42d
Cleared Apr 13, 2015
FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm...
K150705 · GCJ
Minimally Invasive Devices, Inc.
General & Plastic Surgery · 26d