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
27169–27192 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 15, 2017
BioFlux Device
K172311 · DXH
Biotricity, Inc.
Cardiovascular · 136d
Cleared Dec 15, 2017
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam...
K172337 · LTT
Beckman Coulter, Inc.
Microbiology · 135d
Cleared Dec 15, 2017
AxSOS 3 Ti
K172350 · HRS
Stryker GmbH
Orthopedic · 134d
Cleared Dec 15, 2017
Idys™ TLIF 3DTi Cages
K172465 · MAX
Clariance, Sas
Orthopedic · 123d
Cleared Dec 15, 2017
LifeStyles® SKYN® Intimate Moments Personal Lubricant
K172473 · NUC
Sxwell USA, LLC
Obstetrics & Gynecology · 122d
Cleared Dec 15, 2017
The Nellcor pulse oximetry monitor interface cable
K172482 · DQA
Covidien
Anesthesiology · 121d
Cleared Dec 15, 2017
PROTEUS PTA Balloon Catheter with Embolic Capture Feature
K172494 · LIT
Angioslide, Ltd.
Cardiovascular · 119d
Cleared Dec 15, 2017
ReBOSSIS85
K172573 · MQV
Orthorebirth Co., Ltd.
Orthopedic · 109d
Cleared Dec 15, 2017
Proficient® Posterior Cervical Spine System
K172594 · NKG
Spine Wave, Inc.
Orthopedic · 108d
Cleared Dec 15, 2017
Cellvizio 100 Series System with Confocal Miniprobes
K172844 · OWN
Mauna Kea Technologies
General & Plastic Surgery · 87d