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
44497–44520 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 2012
ACCUMESH DEPLOYMENT SYSTEM
K121139 · ORQ
Covidien, LLC
General & Plastic Surgery · 16d
Cleared May 02, 2012
CAIRE COMPANION 5 OXYGEN CONCENTRATOR
K121167 · CAW
Caire, Inc.
Anesthesiology · 15d
Cleared CT May 01, 2012
INRATIO2 PI/NR MONITORING SYSTEM
K110212 · GJS
Alere San Diego, Inc (Formally...
Hematology · 462d
Cleared May 01, 2012
PSYCHEMEDICS COCAINE EIA
K111925 · JXO
Psychemedics Corp.
Toxicology · 300d
Cleared May 01, 2012
PSYCHEMEDICS OPIATES EIA
K111926 · DJG
Psychemedics Corp.
Toxicology · 300d
Cleared May 01, 2012
PSYCHEMEDICS METHAMPHETAMINE EIA
K111927 · LAF
Psychemedics Corp.
Chemistry · 300d
Cleared May 01, 2012
PSYCHEMEDICS PHENCYCLIDINE EIA
K111928 · LCM
Psychemedics Corp.
Chemistry · 300d
Cleared May 01, 2012
PSYCHEMEDICS CANNABINOIDS EIA
K111929 · LDJ
Psychemedics Corp.
Toxicology · 300d
Cleared May 01, 2012
STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
K112593 · ERL
Stryker Corporation
Ear, Nose, Throat · 237d
Cleared May 01, 2012
MONT BLANC PEDICLE SCREW SYSTEMS
K112684 · NKB
Qualgenix
Orthopedic · 229d
Cleared May 01, 2012
AYERS ROCK CERVICAL CAGE
K112801 · ODP
Qualgenix
Orthopedic · 217d
Cleared May 01, 2012
LATERAL FUSION DEVICE
K112986 · MAX
Integra Spine (Integra Lifesciences)
Orthopedic · 208d
Cleared May 01, 2012
ECHELON OVAL MRI SYSTEM
K113145 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 189d
Cleared May 01, 2012
EXTERNAL FIXATOR ST.A R 90 F4
K113384 · KTT
Citieffe
Orthopedic · 167d
Cleared May 01, 2012
VITAL SIGNS MONITOR
K113833 · MWI
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 126d
Cleared May 01, 2012
SPEEDUP SOFTWARE OPTION
K120748 · LNH
Esaote, S.P.A.
Radiology · 50d
Cleared May 01, 2012
ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM
K121044 · NJR
Meridian Bioscience, Inc.
Microbiology · 25d
Cleared Apr 30, 2012
ABX PENTRA CREATININE 120 CP
K110530 · CGX
HORIBA ABX SAS
Chemistry · 431d
Cleared Apr 30, 2012
POWERED MUSCLE STIMULATOR
K112148 · IPF
Valmed, SA
Physical Medicine · 278d
Cleared Apr 30, 2012
OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION
K112909 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 210d
Cleared Apr 30, 2012
EQUINOX RELIEVE
K113687 · BZR
O-Two Medical Technologies, Inc.
Anesthesiology · 137d
Cleared Apr 30, 2012
SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER,...
K120215 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 97d
Cleared Apr 30, 2012
K2 MEDICAL VASCULAR CLAMPS
K120492 · DXC
K2 Medical GmbH & Co. KG
Cardiovascular · 73d
Cleared Apr 27, 2012
RESMART CPAP, RESMART AUTO-CPAP AND RESMART HUMIDIFIER
K110629 · BZD
3B Products, Inc.
Anesthesiology · 420d