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

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175,820 results
23545–23568 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 2019
Double ENDOBUTTON Fixation Device
K183232 · HTN
Smith and Nephew, Inc.
Orthopedic · 112d
Cleared Mar 12, 2019
AirRay Subdural Cortical Electrodes
K183437 · GYC
Cortec GmbH
Neurology · 90d
Cleared Mar 12, 2019
CRYOcheck FVIII Inhibitor Kit
K183440 · GGP
Precision Biologic, Inc.
Hematology · 90d
Cleared Mar 12, 2019
BioPlex 2200 Lyme Total
K183446 · LSR
Bio-Rad Laboratories
Microbiology · 90d
Cleared Mar 12, 2019
Microlife Digital Blood Pressure Monitor
K183469 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 88d
Cleared Mar 12, 2019
VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)
K183524 · LON
bioMerieux, Inc.
Microbiology · 83d
Cleared Mar 12, 2019
INnate Cannulated Screw System
K183603 · HWC
Exsomed Corporation
Orthopedic · 76d
Cleared Mar 12, 2019
Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open...
K183610 · GEI
Bovie Medical Corporation
General & Plastic Surgery · 76d
Cleared Mar 11, 2019
KardiaAI
K181823 · DQK
AliveCor, Inc.
Cardiovascular · 245d
Cleared Mar 11, 2019
EasyInstruments
K182013 · GEI
Agency For Medical Innovations GmbH
General & Plastic Surgery · 227d
Cleared Mar 11, 2019
Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with...
K182241 · LZA
Sri Trang Gloves (Thailand) Co., Ltd.
General Hospital · 203d
Cleared Mar 11, 2019
BoneTrust Implant System
K182313 · DZE
Medical Instinct Deutschland GmbH
Dental · 196d
Cleared Mar 11, 2019
Inno-Pathwire
K182553 · DQX
Suzhou Innomed Medical Device Co., Ltd.
Cardiovascular · 175d
Cleared Mar 11, 2019
KLS Martin Individual Patient Solutions (IPS) Planning System
K182789 · DZJ
KLS-Martin L.P.
Dental · 161d
Cleared Mar 11, 2019
Rotium Bioresorbable Wick
K183236 · MAI
Nanofiber Solutions, LLC
Orthopedic · 111d
Cleared Mar 11, 2019
EVOS Small Fragment Upper Extremity Plates Line Additions
K190253 · HRS
Smith & Nephew, Inc.
Orthopedic · 32d
Cleared Mar 08, 2019
ZAPnea Oral Appliance
K173064 · LRK
B. Fareid, Dds, PC
Dental · 525d
Cleared Mar 08, 2019
RADMAX Digital Imaging Software
K182537 · LLZ
DRGEM Corporation
Radiology · 175d
Cleared Mar 08, 2019
Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads
K182799 · KWS
Arthrex, Inc.
Orthopedic · 157d
Cleared Mar 08, 2019
Bariatric Power Positioning System (BPPS)
K182995 · ITI
Motion Concepts
Physical Medicine · 129d
Cleared Mar 08, 2019
CoreDx™ Pulmonary Mini-Forceps
K183085 · EOQ
Boston Scientific Corporation
Anesthesiology · 122d
Cleared Mar 08, 2019
Kuros TLIF Cage
K183092 · MAX
Kuros Biosciences B.V
Orthopedic · 121d
Cleared Mar 08, 2019
Nitinol Thermocouple (TCN) Electrode
K183177 · GXI
Boston Scientific Corporation
Neurology · 112d
Cleared Mar 08, 2019
cmTriage
K183285 · QFM
Curemetrix, Inc.
Radiology · 102d