Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
66577–66600 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 2005
A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR
K043217 · DXN
A&D Engineering, Inc.
Cardiovascular · 101d
Cleared Mar 03, 2005
MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC...
K043288 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 94d
Cleared Mar 03, 2005
PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01
K043486 · GEX
Topcon Medical Laser Systems, Inc.
General & Plastic Surgery · 76d
Cleared Mar 03, 2005
DUAL LUMEN CATHETER
K043581 · EYB
Acmi Corporation
Gastroenterology & Urology · 65d
Cleared Mar 03, 2005
PRISMATIK CERAMIC
K050144 · EIH
Glidewell Laboratories
Dental · 38d
Cleared Mar 03, 2005
CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE
K050162 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 37d
Cleared Mar 02, 2005
AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060
K041374 · QEW
Idev Technologies, Inc.
Cardiovascular · 282d
Cleared Mar 02, 2005
GYRUS PLASMA SKIN RESURFACING SYSTEM
K041999 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 219d
Cleared Mar 02, 2005
GALEO FOCUS GUIDE WIRE
K042373 · DQX
Biotronik, Inc.
Cardiovascular · 182d
Cleared Mar 02, 2005
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL...
K043133 · KKY
Ceremed , Inc.
General & Plastic Surgery · 110d
Cleared Mar 02, 2005
STRYKER SPINE TRIO PS
K043180 · MNH
Stryker Spine
Orthopedic · 105d
Cleared Mar 02, 2005
THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER
K050227 · MBI
Linvatec Corp.
Orthopedic · 29d
Cleared Mar 01, 2005
TRIFIT 700
K033646 · DRT
Healthfirst Corp.
Cardiovascular · 467d
Cleared Mar 01, 2005
MPS (OR MPS-T)
K041838 · GWM
Innerspace, Inc.
Neurology · 237d
Cleared Mar 01, 2005
TCM40 MONITORING SYSTEM
K043003 · LKD
Radiometer Medical Aps
Anesthesiology · 120d
Cleared Mar 01, 2005
MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER
K043120 · CAH
Datex-Ohmeda, Inc.
General Hospital · 109d
Cleared Mar 01, 2005
MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE
K043398 · DQX
Neometrics, Inc.
Cardiovascular · 81d
Cleared Mar 01, 2005
STERILEMED REPROCESSED IVUS IMAGING CATHETER
K043453 · OWQ
Sterilmed, Inc.
Cardiovascular · 76d
Cleared Mar 01, 2005
STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER
K043513 · NLH
Sterilmed, Inc.
Cardiovascular · 71d
Cleared Mar 01, 2005
C-CO2 COLORIMETRIC CO2 INDICATOR
K050066 · CCK
Marquest Medical Products, Inc.
Anesthesiology · 48d
Cleared Mar 01, 2005
RESMED MERIDIAN MASK
K050142 · BZD
Resmed, Ltd.
Anesthesiology · 36d
Cleared Mar 01, 2005
SOMATOM EMOTION 16
K050297 · JAK
Siemens Medical Solution, Inc. USA
Radiology · 22d
Cleared Mar 01, 2005
TULIP CONDOM
K050360 · HIS
Shanghai Latex Factory
Obstetrics & Gynecology · 15d
Cleared Feb 28, 2005
SNORENTI
K032410 · LQZ
James P Boyd
Dental · 574d