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
46537–46560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 2011
MRGFUS PELVIC PA COIL MODEL 1.0
K111060 · MOS
Insightech, Ltd.
Radiology · 144d
Cleared Sep 09, 2011
ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000
K111116 · CBK
Datex-Ohmeda
Anesthesiology · 141d
Cleared Sep 09, 2011
AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING
K111285 · GEI
Salient Surgical Technologies, Inc.
General & Plastic Surgery · 126d
Cleared Sep 09, 2011
RESOLUTIONMD MOBILE MODEL RMB-MOB-2X
K111346 · LLZ
Calgary Scientific, Inc.
Radiology · 119d
Cleared Sep 09, 2011
UNIMAX ANTI-FOG SOLUTION
K111622 · OCT
Unimax Medical Systems, Inc.
Gastroenterology & Urology · 91d
Cleared Sep 09, 2011
ENDOSKELETON(R) TAS
K111626 · OVD
Titan Spine, LLC
Orthopedic · 91d
Cleared Sep 09, 2011
SMITH & NEPHEW RJ CONSTRAINED LINERS
K111635 · KWZ
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Sep 09, 2011
AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX
K111704 · DQY
Avinger, Inc.
Cardiovascular · 84d
Cleared Sep 09, 2011
.DECIMAL ELECTRON APERTURE
K111759 · IXI
.Decimal, Inc.
Radiology · 79d
Cleared Sep 09, 2011
CLOSUREFAST RADIOFREQUENCY CATHETER
K111887 · GEI
Covidien
General & Plastic Surgery · 70d
Cleared Sep 09, 2011
TOSHIBA 3T EXTRA LARGE KNEE COIL
K112313 · MOS
Quality Electrodynamics
Radiology · 29d
Cleared Sep 09, 2011
SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES
K112327 · DSP
Cardiac Assist, Maquet...
Cardiovascular · 28d
Cleared Sep 09, 2011
WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST
K112395 · LFG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 21d
Cleared Sep 08, 2011
FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION...
K103132 · LPL
Oculus Private Limited
Ophthalmic · 318d
Cleared Sep 08, 2011
ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT,...
K103615 · CDN
Alfa Wassermann Diagnostic...
Chemistry · 273d
Cleared Sep 08, 2011
PROLINK ADHESIVES (PROLINK, PROLINK SE)
K110403 · KLE
Silmet , Ltd.
Dental · 209d
Cleared Sep 08, 2011
POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL...
K110818 · CIX
Polymedco, Inc.
Chemistry · 168d
Cleared Sep 08, 2011
A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)
K111166 · MAX
Spineworks, LLC
Orthopedic · 135d
Cleared Sep 08, 2011
FIXATE TISSUE BAND
K111462 · GZB
Anulex Technologies, Inc.
General & Plastic Surgery · 105d
Cleared Sep 08, 2011
RTVUE CAM WITH CORNEAL POWER UPGRADE
K111505 · OBO
Optovue, Inc.
Ophthalmic · 100d
Cleared Sep 08, 2011
MEDLINE VIAL DECANTER
K111577 · LHI
Medline Industries, Inc.
General Hospital · 93d
Cleared Sep 08, 2011
XELIS FUSION
K111613 · LLZ
Infinitt Co., Ltd.
Radiology · 91d
Cleared Sep 08, 2011
SV BRAIN ARRAY, SIEMENS 3T
K111802 · MOS
Mri Interventions, Inc.
Radiology · 73d
Cleared Sep 08, 2011
PREFILLED CATHETER INFLATION SYRINGE
K112209 · KNY
Avail Medical Products, Inc.
Gastroenterology & Urology · 38d