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

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176,076 results
54985–55008 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 26, 2008
MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS6000
K083115 · DRG
Intel Corp.
Cardiovascular · 36d
Cleared Nov 26, 2008
QV-9000 UNIVERSAL SYSTEM
K083181 · KPR
Quantum Medical Imaging, LLC
Radiology · 29d
Cleared Nov 26, 2008
CARDIO-VIEW
K083321 · DXJ
Curlview Igt, LLC
Cardiovascular · 15d
Cleared Nov 26, 2008
LEVITRONIX CENTRIMAG PRIMARY CONSOLE
K083340 · DWA
Levitronix, LLC
Cardiovascular · 14d
Cleared Nov 25, 2008
VALLEYLAB MICROWAVE ABLATION GENERATOR
K072687 · NEY
Covidien Lp, Formerly Know AS...
General & Plastic Surgery · 428d
Cleared Nov 25, 2008
BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP,...
K080467 · LDJ
Applied Dna Technologies, Inc.
Toxicology · 278d
Cleared Nov 25, 2008
POGO SCREW
K080649 · HWC
Fxdevices
Orthopedic · 263d
Cleared Nov 25, 2008
MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0
K081867 · HAW
Mako Surgical Corp.
Neurology · 147d
Cleared Nov 25, 2008
MAJOR.REPAIR
K082153 · EBI
Major Prodotti Dentari S.P.A.
Dental · 118d
Cleared Nov 25, 2008
KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.5
K082200 · DZE
SOADCO, S.L.
Dental · 113d
Cleared Nov 25, 2008
BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT
K082253 · MNW
Bodystat , Ltd.
Gastroenterology & Urology · 109d
Cleared Nov 25, 2008
SMITH & NEPHEW, INC. PATIENT MATCHED TECHNOLOGY
K082358 · JWH
Smith & Nephew, Inc.
Orthopedic · 99d
Cleared Nov 25, 2008
PRODIGY NPWT SYSTEM MODEL PRODIGY 800V
K082415 · OMP
Premco Medical Systems, Inc.
General & Plastic Surgery · 96d
Cleared Nov 25, 2008
ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES
K082575 · MQV
Apatech , Ltd.
Orthopedic · 81d
Cleared Nov 25, 2008
ENTERAL ONLY EXTENSION SET
K082654 · KNT
Respironics, Inc.
Gastroenterology & Urology · 74d
Cleared Nov 25, 2008
ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101
K082655 · CCL
Envitec-Wismar GmbH
Anesthesiology · 74d
Cleared Nov 25, 2008
ORLUS MINI SCREW
K082838 · DZE
Ortholution Co., Ltd.
Dental · 60d
Cleared Nov 25, 2008
BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET...
K082844 · LZO
Encore Medical, L.P.
Orthopedic · 60d
Cleared Nov 25, 2008
AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561
K082861 · MKJ
Amco International Manufacturing &...
Cardiovascular · 57d
Cleared Nov 25, 2008
ORTHOPEDIATRICS BONE SCREWS
K082949 · HWC
OrthoPediatrics Corp.
Orthopedic · 54d
Cleared Nov 25, 2008
VIPERSPHERE PTA BALLOON CATHETER
K083139 · DQY
Cardiovascular Systems, Inc.
Cardiovascular · 33d
Cleared Nov 24, 2008
MODEL ES-130
K081943 · BWK
Ito Co., Ltd.
Neurology · 139d
Cleared Nov 24, 2008
PROGENIX PLUS
K082002 · MQV
Medtronic Sofamor Danek
Orthopedic · 133d
Cleared Nov 24, 2008
USS ILIOSACRAL, USS POLYAXIAL
K082572 · NKB
Synthes Spine
Orthopedic · 80d