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
47017–47040 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 15, 2011
WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO...
K111560 · DKZ
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 42d
Cleared Jul 15, 2011
VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM
K111706 · IYO
Volcano Corporation
Radiology · 28d
Cleared Jul 15, 2011
G-SCAN
K111803 · LNH
Esaote, S.P.A.
Radiology · 18d
Cleared Jul 15, 2011
E-CUBE 9
K111864 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 15d
Cleared Jul 14, 2011
PERCUPRO MESSENGER BALLOON CATHETER
K094048 · DYG
Cardiosolutions, Inc.
Cardiovascular · 560d
Cleared Jul 14, 2011
NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER
K110285 · FIP
Nephros, Inc.
Gastroenterology & Urology · 164d
Cleared Jul 14, 2011
OSSEOFUSE DENTAL IMPLANT SYSTEM
K110577 · DZE
Dynamic Innovations, Inc.
Dental · 135d
Cleared Jul 14, 2011
TIGER SYRINGES AND NEEDLES
K110697 · FMF
Tiger Medical Products, Ltd.
General Hospital · 122d
Cleared Jul 14, 2011
CARA
K110869 · NFJ
Diagnos, Inc.
Ophthalmic · 107d
Cleared Jul 14, 2011
ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE
K110960 · LZA
Koon Seng Sdn Bhd
General Hospital · 100d
Cleared Jul 14, 2011
AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
K111034 · NGT
Am USA
General Hospital · 92d
Cleared Jul 14, 2011
STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT
K111065 · GWO
Howmedica Osteonics Corp. Dba Stryker...
General & Plastic Surgery · 87d
Cleared Jul 14, 2011
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, BLUE COLOR
K111240 · LYZ
Xuzhou Full Sun Medical Products , Ltd.
General Hospital · 72d
Cleared Jul 14, 2011
SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT...
K111856 · LRX
Apothecary Products, Inc.
Ophthalmic · 15d
Cleared Jul 13, 2011
EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR
K101089 · DCF
Medica Corp.
Chemistry · 450d
Cleared Jul 13, 2011
ECG PEN
K103077 · DPS
Meridian Dynamics Biomedical, Inc.
Cardiovascular · 268d
Cleared Jul 13, 2011
POWDER FREE NITRILE EXAMINATION GLOVES
K110418 · LZA
W.A. Rubbermate Co., Ltd.
General Hospital · 149d
Cleared Jul 13, 2011
CARDIAC SCANNER AND PROCESSING SYSTEM
K110507 · KPS
Spectrum Dynamics (Israel) , Ltd.
Radiology · 141d
Cleared Jul 13, 2011
ATLAS SPINE PEDICLE SCREW SYSTEM
K110842 · NKB
Atlas Spine, Inc.
Orthopedic · 110d
Cleared Jul 13, 2011
APEX KNEE SYSTEM, APEX ALL POLY TIBIA
K111062 · JWH
Omni Life Science, Inc.
Orthopedic · 86d
Cleared Jul 13, 2011
PANOURA 18S
K111231 · MUH
The Yoshida Dental Mfg. Co., Ltd.
Radiology · 72d
Cleared Jul 13, 2011
SANTEVIEW
K111312 · MQB
Sehyun Co., Ltd.
Radiology · 64d
Cleared Jul 13, 2011
MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR
K111652 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 30d
Cleared Jul 13, 2011
VACCESS PTA DILATATION CATHETER
K111850 · DQY
C.R. Bard, Inc.
Cardiovascular · 14d