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
62377–62400 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 2006
OPTERYX ANTERIOR CERVICAL PLATE SYSTEM
K061147 · KWQ
Innovasis, Inc.
Orthopedic · 66d
Cleared Jun 30, 2006
KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER
K061197 · KPE
Kawasumi Laboratories, Inc.
General Hospital · 63d
Cleared Jun 30, 2006
DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140
K061218 · JIX
Dade Behring, Inc.
Chemistry · 60d
Cleared Jun 30, 2006
ERCH ARCH BAR, MODEL 38-690-00
K061271 · DYX
KLS-Martin L.P.
Dental · 56d
Cleared Jun 30, 2006
TRANQUIL TRI-BTE
K061459 · KLW
General Hearing Instruments, Inc.
Ear, Nose, Throat · 35d
Cleared Jun 30, 2006
CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM
K061488 · IYN
Shantou Institute of Ultrasonic...
Radiology · 30d
Cleared Jun 30, 2006
ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200
K061538 · MQB
Alara, Inc.
Radiology · 28d
Cleared Jun 30, 2006
SCENIUM 1.1
K061545 · KPS
Siemens Molecular Imaging, Ltd.
Radiology · 25d
Cleared Jun 29, 2006
GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE)
K051278 · DWJ
Rg Ent., Inc.
Cardiovascular · 408d
Cleared Jun 29, 2006
GERATHERM SOS-RESCUE BAG
K051336 · DWJ
R.G. Enterprises, Inc.
Cardiovascular · 402d
Cleared Jun 29, 2006
NPOSES (NOCTURNAL PULSE OXIMETRY STUDY EXPERT SYSTEM), MODEL NPOSES-100
K060616 · DQA
PHD Medical
Anesthesiology · 113d
Cleared Jun 29, 2006
CAROTID ACCESS KIT
K060666 · DYB
Terumo Medical Corp.
Cardiovascular · 107d
Cleared Jun 29, 2006
Y-CLICK CONNECTOR
K060759 · DTL
Elcam Medical Acal
Cardiovascular · 100d
Cleared Jun 29, 2006
VASHE WOUND CLEANSING SYSTEM
K060901 · FRO
Sterilox Technologies, Inc.
General & Plastic Surgery · 87d
Cleared Jun 29, 2006
SONOHYSTEROGRAPHY BIOPSY DEVICE
K060908 · PGK
Cook Urological, Inc.
Obstetrics & Gynecology · 87d
Cleared Jun 29, 2006
AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE
K061039 · FMF
Amsino International, Inc.
General Hospital · 76d
Cleared Jun 29, 2006
CALCANEAL TRAUMA SYSTEM
K061400 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 41d
Cleared Jun 29, 2006
PRIMATRIX DERMAL REPAIR SCAFFOLD
K061407 · KGN
Tei Biosciences, Inc.
General & Plastic Surgery · 38d
Cleared Jun 29, 2006
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BU1-4U
K061558 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 24d
Cleared Jun 29, 2006
MODIFICATION TO I VENT 201
K061627 · CBK
Versamed Medical Systems, Inc.
Anesthesiology · 17d
Cleared Jun 29, 2006
SYNGO TRUED, MODEL VC10A
K061671 · LLZ
Siemens Medical Solutions
Radiology · 15d
Cleared Jun 29, 2006
SYNAPSE MIP/MPR IMAGE VISUALIZATION SOFTWARE OBLIQUUS
K061672 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 15d
Cleared Jun 28, 2006
BABY SNOOPY WATER FILLED TEETHER, MODEL 95367
K052513 · KKO
Delta Enterprise Corporation
Dental · 287d
Cleared Jun 28, 2006
PARTIAL OSSICULAR REPLACEMENT PROSTHESES
K060518 · ETB
Grace Medical, Inc.
Ear, Nose, Throat · 121d