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

Filters: Cleared only ×
176,076 results
61273–61296 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 2006
OSTEOMED EXTENDED 2.0/2.4CANNULATED SCREW SYSTEM
K062863 · HWC
Osteomed LP
Orthopedic · 36d
Cleared Oct 31, 2006
M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT
K062995 · KWA
Biomet Manufacturing Corp
Orthopedic · 29d
Cleared Oct 31, 2006
ALTRA PRESS-FIT HIP SYSTEM
K063002 · KWA
Biomet Manufacturing Corp
Orthopedic · 29d
Cleared Oct 31, 2006
HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT
K063191 · OBO
Heidelberg Engineering
Ophthalmic · 11d
Cleared Oct 30, 2006
MEDLOG, MODEL 1-0-10
K060756 · MWI
Bmc Gesellschaft Fur Medizintechnik Mbh
Cardiovascular · 223d
Cleared Oct 30, 2006
GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM
K061234 · NBW
Glucoplus, Inc.
Chemistry · 181d
Cleared Oct 30, 2006
BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000
K061922 · DJZ
Sentech Korea Corp.
Chemistry · 115d
Cleared Oct 30, 2006
QUANTIMETRIX NICOSURE COTININE URINE CONTROL
K062942 · LAS
Quantimetrix Corp.
Toxicology · 32d
Cleared Oct 30, 2006
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K062967 · MUJ
Accuray, Inc.
Radiology · 31d
Cleared Oct 30, 2006
LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI...
K063024 · DKZ
Lin-Zhi International, Inc.
Chemistry · 28d
Cleared Oct 27, 2006
SUPERCATH V
K052267 · FIE
Togo Medikit Co., Ltd.
Gastroenterology & Urology · 434d
Cleared Oct 27, 2006
VISTADENT OC - VERSION 4
K060836 · LLZ
Dentsply Intl., Inc.
Radiology · 213d
Cleared Oct 27, 2006
SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE
K060889 · KIF
Pentron Clinical Technologies
Dental · 210d
Cleared Oct 27, 2006
GYNESONICS EC6 TRANSDUCER
K061153 · ITX
Gynesonics, Inc.
Radiology · 184d
Cleared Oct 27, 2006
RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES
K062010 · FLL
Global Treasure Industries , Ltd.
General Hospital · 102d
Cleared Oct 27, 2006
RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES
K062016 · FLL
Choice Smart Health Care Co. , Ltd.
General Hospital · 102d
Cleared Oct 27, 2006
INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0
K062068 · DPS
Intelwave, LLC
Cardiovascular · 98d
Cleared Oct 27, 2006
DIRECT DIGITAL RADIOGRAPHY CCD IMAGING SENSOR, NAOMI
K062376 · MQB
Rf Systems Lab.
Radiology · 73d
Cleared Oct 27, 2006
BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500
K062438 · KNA
Cook Ob/Gyn
Obstetrics & Gynecology · 67d
Cleared Oct 27, 2006
AMICAS VISION SERIES PACS, MODEL 4.3
K062477 · LLZ
Amicas, Inc.
Radiology · 64d
Cleared Oct 27, 2006
VISAGE PACS/CS, RELEASE VERSION 4.1
K062490 · LLZ
Mercury Computer Systems, Inc.
Radiology · 63d
Cleared Oct 27, 2006
MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098
K062653 · LFD
Parnell Pharmaceuticals, Inc.
Dental · 50d
Cleared Oct 27, 2006
ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400
K062716 · FRA
Eco-Rx, Inc.
General Hospital · 45d
Cleared Oct 27, 2006
TUTU 7, MODEL IV-T22
K062735 · EBZ
Invisible Technology Co., Ltd.
Dental · 44d