FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
27457–27480 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 2017
DEKA SMARTXIDE ULTRASPEED
K172363 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 105d
Cleared Nov 17, 2017
Dr.MUSIC 3s
K172451 · NUH
Smartmedicaldevice Co., Ltd.
Neurology · 95d
Cleared Nov 17, 2017
Micro-MEC 1.8% Glutaraldehyde Monitor Strip
K172472 · JOJ
STERIS Corporation
General Hospital · 94d
Cleared Nov 17, 2017
Trak Plus Male Fertility Testing System
K172514 · POV
Sandstone Diagnostics, Inc.
Hematology · 88d
Cleared Nov 17, 2017
Duravess bovine pericardial vascular patch
K172660 · PSQ
Edwards Lifesciences, LLC
Cardiovascular · 73d
Cleared Nov 17, 2017
New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)
K172761 · EIH
Shanghai New Century Dental Materials...
Dental · 65d
Cleared Nov 17, 2017
SterilContainer with PrimeLine Pro Lid
K172850 · KCT
Aesculap, Inc.
General Hospital · 58d
Cleared Nov 17, 2017
Vantage Titan 3T, MRT-3010/A7, M-Power GX
K172878 · LNH
Toshiba Medical Systems Corporation,...
Radiology · 57d
Cleared Nov 17, 2017
Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold
K173023 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 50d
Cleared Nov 17, 2017
Performer Introducer
K173068 · DYB
Cook Incorporated
Cardiovascular · 49d
Cleared Nov 17, 2017
NeuroBlate System
K173305 · GEX
Monteris Medical,
General & Plastic Surgery · 30d
Cleared Nov 17, 2017
Gastric Sizing Balloon Catheter
K173355 · KNT
Cook Incorporated
Gastroenterology & Urology · 23d
Cleared Nov 17, 2017
Bausch + Lomb Boston Scleral Lens Case
K173365 · LRX
Bausch & Lomb, Incorporated
Ophthalmic · 22d
Cleared Nov 17, 2017
MR Wire Guide Wire Straight, MR Wire Guide Wire Angled
K173423 · DQX
Nano4imaging GmbH
Cardiovascular · 16d
Cleared Nov 17, 2017
Contour 24
K173446 · MOS
Quality Electrodynamics, LLC
Radiology · 11d
Cleared Nov 16, 2017
Intra.Ox Handheld Tissue Oximeter
K163472 · MUD
Vioptix, Inc.
Cardiovascular · 339d
Cleared Nov 16, 2017
SIRIO H3
K163643 · JAK
Masmec Spa
Radiology · 328d
Cleared Nov 16, 2017
Klockner Vega TiBase for CEREC
K170022 · NHA
SOADCO, S.L.
Dental · 317d
Cleared Nov 16, 2017
Merits Model R106/R136 Rehab Wheelchair
K170517 · IOR
Merits Healthcare Industries (Suzhou)...
Physical Medicine · 268d
Cleared Nov 16, 2017
Acrylic Herbst Appliance with Micro-Recorder
K170606 · PLC
Gergen'S Orthodontic Lab
Dental · 260d
Cleared Nov 16, 2017
LeEject 2 Dental Syringe and Needle System
K171254 · EJI
Advanced Technology and Capital, Inc.
Dental · 202d
Cleared Nov 16, 2017
NEPHROCHECK Test System
K171482 · PIG
Astute Medical, Inc.
Chemistry · 181d
Cleared Nov 16, 2017
Renovis Surgical Hip Replacement System
K171543 · OQG
Renovis Surgical Technologies
Orthopedic · 174d
Cleared Nov 16, 2017
MC3 QuickFlow Dual Lumen Catheter
K171610 · PZS
Mc3 Incorporated
Cardiovascular · 168d