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
40753–40776 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 2013
KLOCKNER DENTAL IMPLANT ABUTMENTS
K122988 · NHA
SOADCO, S.L.
Dental · 296d
Cleared Jul 19, 2013
T1040 AKA AURAWAVE
K124055 · NUH
Endurance Therapeutics
Neurology · 200d
Cleared Jul 19, 2013
DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)
K130068 · BYJ
Essex Industries, Inc. D/B/A Essex...
Anesthesiology · 189d
Cleared Jul 19, 2013
MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER
K130079 · MUD
Reflectance Medical, Inc.
Cardiovascular · 186d
Cleared Jul 19, 2013
DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE...
K130136 · GXZ
Technomed Europe
Neurology · 182d
Cleared Jul 19, 2013
ELIXBO PM545
K130658 · LNH
Xbo Medical Systems Co., Ltd.
Radiology · 129d
Cleared Jul 19, 2013
STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW
K130731 · HRS
Stabiliz Orthopaedics, LLC
Orthopedic · 123d
Cleared Jul 19, 2013
NAVIGATION PIN
K131130 · OLO
Evergreen Orthopedic Research Lab
Orthopedic · 87d
Cleared Jul 19, 2013
IHEALTH CLOUD
K131203 · DXN
Andon Health Co, Ltd.
Cardiovascular · 81d
Cleared Jul 19, 2013
CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER
K131332 · DYB
Cardiosolutions, Inc.
Cardiovascular · 71d
Cleared Jul 19, 2013
UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
K131811 · DKZ
Ucp Biosciences, Inc.
Toxicology · 30d
Cleared Jul 18, 2013
NAOMI-CT
K123332 · OAS
Lk Consulting Group
Radiology · 265d
Cleared Jul 18, 2013
PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM
K130088 · MUH
Genoray Co., Ltd.
Radiology · 185d
Cleared Jul 18, 2013
ICT
K130224 · JAK
Imris, Inc.
Radiology · 170d
Cleared Jul 18, 2013
CERTUS 140 CERTUSURGGT SURGICAL TOOL
K130399 · NEY
Neuwave Medical, Inc.
General & Plastic Surgery · 149d
Cleared Jul 18, 2013
VASCULAIRE COMPRESSION SYSTEM, VASCULAIRE SLEEVE (FOOT & CALF), VASCULAIRE...
K131046 · JOW
Venous Health Systems, Inc.
Cardiovascular · 94d
Cleared Jul 18, 2013
21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5)
K131137 · LLZ
Jvckenwood Corporation
Radiology · 86d
Cleared Jul 18, 2013
CENTRIMAG PRIMARY CONSOLE (2ND GENERATION)
K131179 · DWA
Thoratec Corp
Cardiovascular · 84d
Cleared Jul 18, 2013
BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM
K131327 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 71d
Cleared Jul 18, 2013
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K131467 · JWH
Conformis, Inc.
Orthopedic · 58d
Cleared Jul 18, 2013
NEOCLOSE HASSON, NEOCLOSE UNIVERSAL
K131688 · GCJ
Neosurgical, Ltd.
General & Plastic Surgery · 38d
Cleared Jul 18, 2013
ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3
K131776 · JJX
Randox Laboratories, Ltd.
Chemistry · 31d
Cleared Jul 18, 2013
INPULSE LASER
K131805 · GEX
Incisive, Inc.
General & Plastic Surgery · 29d
Cleared Jul 18, 2013
SOLID GEL PAD
K131905 · MUI
Bluemtech
Radiology · 22d