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
26569–26592 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2017
SuperGrow 272, Ultimate 272
K172982 · OAP
Super Grow Lasers
General & Plastic Surgery · 83d
Cleared Dec 19, 2017
Zmachine Synergy
K172986 · OLV
Consolidated Research of Richmond,...
Neurology · 83d
Cleared Dec 19, 2017
Reform® Midline Cortical Screw System
K173130 · NKB
Precision Spine, Inc.
Orthopedic · 81d
Cleared Dec 19, 2017
LumiCoil Platinum Fiducial Marker
K173251 · IYE
Boston Scientific Corporation
Radiology · 70d
Cleared Dec 19, 2017
Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL
K173307 · JWY
Liofilchem S. R. L.
Microbiology · 62d
Cleared Dec 19, 2017
MAGNETOM Amira
K173600 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Dec 19, 2017
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter
K173618 · OBJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 27d
Cleared Dec 19, 2017
FS Ergo
K173646 · MUH
Palodex Group OY
Radiology · 22d
Cleared Dec 19, 2017
TBL-ABI System
K173696 · JOM
Ld Technology, LLC
Cardiovascular · 18d
Cleared Dec 18, 2017
PERIO-FLOW nozzle
K171174 · EFB
E.M.S Electro Medical Systems S.A
Dental · 241d
Cleared Dec 18, 2017
Certa Catheter
K171193 · BSO
Ferrosan Medical Devices Sp. Z.O.O.
Anesthesiology · 238d
Cleared Dec 18, 2017
Sidus Stem-Free Shoulder
K171858 · PKC
Zimmer GmbH
Orthopedic · 180d
Cleared Dec 18, 2017
Automated Blood Coagulation Analyzer CS-2500
K172286 · JPA
Siemens Healthcare Diagnostic...
Hematology · 143d
Cleared Dec 18, 2017
DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)
K172918 · MUH
Kavo Dental Technologies, LLC
Radiology · 84d
Cleared Dec 18, 2017
PEEK Biosolution
K173124 · EBF
Merz Dental GmbH
Dental · 80d
Cleared Dec 17, 2017
HAL for Medical Use (Lower Limb Type)
K171909 · PHL
Cyberdyne, Inc.
Neurology · 174d
Cleared Dec 15, 2017
ECG Acquisition Systems
K163607 · DPS
Vales & Hills Biomedical Tech. , Ltd.
Cardiovascular · 359d
Cleared Dec 15, 2017
FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile
K170029 · KFM
International Biophysics Corporation
Cardiovascular · 345d
Cleared Dec 15, 2017
V10
K170497 · DXN
Mediana Co., Ltd.
Cardiovascular · 301d
Cleared Dec 15, 2017
Composite Removable Sinus Stent System
K170913 · LYA
Sts Medical
Ear, Nose, Throat · 262d
Cleared Dec 15, 2017
Polyform Synthetic Mesh
K171271 · OTO
Boston Scientific Corporation
Obstetrics & Gynecology · 228d
Cleared Dec 15, 2017
ArchFlo CT Midline
K171483 · PND
Medcomp (Dba Medical Components, Inc.)
General Hospital · 207d
Cleared Dec 15, 2017
Double Lumen Ovum Aspiration Needles
K171611 · MQE
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 197d
Cleared Dec 15, 2017
pioli IOL Delivery System
K172228 · MSS
Ast Products, Inc.
Ophthalmic · 143d