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
27073–27096 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 2017
Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low...
K173104 · OQG
Total Joint Orthopedics, Inc.
Orthopedic · 28d
Cleared Oct 27, 2017
Abbott Architect Free T4
K173122 · CEC
Abbott Laboratories
Chemistry · 28d
Cleared Oct 27, 2017
ASPIRE Cristalle
K173132 · MUE
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 28d
Cleared Oct 27, 2017
Biim Diagnostic Ultrasound System
K173138 · IYO
Biim Ultrasound AS
Radiology · 28d
Cleared Oct 27, 2017
Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
K173184 · ODG
Boston Scientific
Gastroenterology & Urology · 28d
Cleared Oct 26, 2017
Healing Cap Multi-Unit Titanium
K171142 · NHA
Nobel Biocare AB
Dental · 191d
Cleared Oct 26, 2017
Intra-Lock Bone Fixation System
K171831 · DZL
Intra-Lock International, Inc.
Dental · 128d
Cleared Oct 26, 2017
Celerity ECG Cable Accessory Pack
K171931 · LJS
Medcomp (Medical Components, Inc.)
General Hospital · 120d
Cleared Oct 26, 2017
Omnia Medical VBR
K172323 · MQP
Omnia Medical, LLC
Orthopedic · 86d
Cleared Oct 26, 2017
Rhapsody H-30 Holmium Laser System
K172325 · GEX
Cook Incorporated
General & Plastic Surgery · 86d
Cleared Oct 26, 2017
NuVasive® Modulus TLIF Interbody System
K172341 · MAX
Nu Vasive, Incorporated
Orthopedic · 85d
Cleared Oct 26, 2017
SILC® Fixation System
K172417 · OWI
Globus Medical, Inc.
Orthopedic · 77d
Cleared Oct 26, 2017
EPI K Console
K172994 · HNO
Moria SA
Ophthalmic · 29d
Cleared Oct 26, 2017
SeaSpine Ventura NanoMetalene System
K173022 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 28d
Cleared Oct 26, 2017
Cocoon Portable Handheld X-Ray System
K173046 · MUH
Dexcowin Co., Ltd.
Radiology · 28d
Cleared Oct 26, 2017
OrthoVision
K173094 · LLZ
Ewoosoft Co., Ltd.
Radiology · 27d
Cleared Oct 25, 2017
Smart Photon Micro-current Device, Model: EP-300
K162652 · NFO
Li-Tek Electronic Technology Corporation
Neurology · 397d
Cleared Oct 25, 2017
Advance Medical Designs, Inc. Sterile Ultrasound Gel
K163050 · MUI
Advance Medical Designs, Inc.
Radiology · 358d
Cleared Oct 25, 2017
iTotal Family Reusable Instrument Tray
K170226 · KCT
Conformis, Inc.
General Hospital · 273d
Cleared Oct 25, 2017
Emit II Plus Cocaine Metabolite Assay
K170293 · DIO
Siemens Healthcare Diagnostics, Inc.
Toxicology · 267d
Cleared Oct 25, 2017
SunCHECK
K170307 · IYE
Sun Nuclear Corporation
Radiology · 266d
Cleared Oct 25, 2017
DentureID Microchip
K170423 · PYQ
Cmp Industries, LLC
General Hospital · 254d
Cleared Oct 25, 2017
Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U
K170454 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 252d
Cleared Oct 25, 2017
Cortina™ Lumbar Cage System
K171914 · MAX
Neurostructures, Inc.
Orthopedic · 121d