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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
35041–35064 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 2015
ANSISTIM
K141168 · BWK
Dyansys, Inc.
Neurology · 374d
Cleared May 15, 2015
CLINISCANSM EEG
K141883 · OMB
Picofemto, LLC
Neurology · 308d
Cleared May 15, 2015
Propeller System
K142516 · CAF
Reciprocal Labs Corporation
Anesthesiology · 249d
Cleared May 15, 2015
Chi Lites Orthodontic Sapphire Bracket
K142729 · NJM
Progressive Technology, Inc.
Dental · 234d
Cleared May 15, 2015
Rebel 3DKNEE System
K143242 · JWH
Encore Medical, L.P.
Orthopedic · 184d
Cleared May 15, 2015
Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways
K143294 · JAK
Toshibamedical Systems Corporation
Radiology · 179d
Cleared May 15, 2015
Brainscope Ahead 200
K143643 · PIW
Brainscope Company, Inc.
Neurology · 144d
Cleared May 15, 2015
Rhondium One-Visit-Crown(OVC)
K143694 · EBF
Rhondium, Ltd.
Dental · 142d
Cleared May 15, 2015
Minhua Disposable Blood Pressure Cuff
K143728 · DXQ
Suzhou Minhua Medical Apparatus
Cardiovascular · 137d
Cleared May 15, 2015
SculpSure
K150230 · PKT
Cynosure, Inc.
General & Plastic Surgery · 102d
Cleared May 15, 2015
IS4000 da Vinci EndoWrist Instruments
K150284 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 99d
Cleared May 15, 2015
BioFlo Midline Catheter
K150407 · FOZ
Navilyst Medical, Inc.
General Hospital · 86d
Cleared May 15, 2015
JuggerStitch Meniscal Repair Device
K150424 · MBI
Biomet Manufacturing Corp
Orthopedic · 85d
Cleared May 15, 2015
Interbody Fusion (IBF)/Vertebral Body Replacement(VBR) System
K150521 · ODP
Rti Surgical, Inc. Dba Rti Biologics
Orthopedic · 74d
Cleared May 15, 2015
.decimal Astroid Dosimetry App
K150547 · MUJ
.Decimal, Inc.
Radiology · 73d
Cleared May 15, 2015
Datalys Multi-Parameter Patient Monitor
K150691 · MWI
Lutech Industries, Inc.
Cardiovascular · 58d
Cleared May 15, 2015
Centurion POCT System
K150822 · NKG
Orthofix, Inc.
Orthopedic · 49d
Cleared May 15, 2015
Flexicare Heated Wire Breathing Systems
K150900 · BZE
Flexicare Medical, Ltd.
Anesthesiology · 42d
Cleared May 15, 2015
Arthrex RetroFusion Screw
K151078 · HWC
Arthrex, Inc.
Orthopedic · 23d
Cleared May 15, 2015
Active Breathing Coordinator
K151097 · IYE
Aktina Medical Corporation
Radiology · 21d
Cleared May 15, 2015
ZONARE ZS3 Diagnostic Ultrasound System
K151175 · IYN
Zonare Medical Systems, Inc.
Radiology · 14d
Cleared May 14, 2015
Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood...
K140150 · NBW
Hmd Biomedical, Inc.
Chemistry · 477d
Cleared May 14, 2015
DISPOSABLE CERVICAL BRUSH
K141057 · HHT
Ningbo Hls Medical Products Co., Ltd.
Obstetrics & Gynecology · 385d
Cleared May 14, 2015
PURICORE WOUND HYDROGEL SPRAY DRESSING
K141863 · FRO
Puricore, Inc.
General & Plastic Surgery · 308d