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
50065–50088 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 2010
EARPROBE
K100661 · GWJ
Path Medical GmbH
Neurology · 115d
Cleared Jul 01, 2010
TILOCK PEDICLE SCREW SYSTEM
K100757 · NKB
Genesys Spine
Orthopedic · 106d
Cleared Jul 01, 2010
PK SUPERPULSE SYSEM GENERATOR MODEL 744000
K100816 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 100d
Cleared Jul 01, 2010
BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST
K100817 · KHE
Princeton BioMeditech Corp.
Hematology · 104d
Cleared Jul 01, 2010
GYNECARE TVT ABBREVO CONTINENCE SYSTEM
K100936 · OTN
Ethicon, Inc.
Gastroenterology & Urology · 87d
Cleared Jul 01, 2010
SPINESMITH CYNCH SPINAL SYSTEM
K101085 · MAX
Spine Smith Partners L.P.
Orthopedic · 73d
Cleared Jul 01, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (BLUE, WHITE, PINK)
K101132 · LYZ
Hong DI Plastic Products Co., Ltd.
General Hospital · 70d
Cleared Jul 01, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE,BLUE, PINK)
K101135 · LYZ
Hongze Plastic Technology Co., Ltd.
General Hospital · 70d
Cleared Jul 01, 2010
LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC
K101190 · OHS
Led Intellectual Properties, LLC
General & Plastic Surgery · 64d
Cleared Jul 01, 2010
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY...
K101293 · LZA
Pt. Smartglove Indonesia
General Hospital · 52d
Cleared Jul 01, 2010
EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031
K101457 · NBW
Eps Bio Technology Corp.
Chemistry · 36d
Cleared Jul 01, 2010
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCHBP OFFICE...
K101512 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 30d
Cleared Jul 01, 2010
GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN
K101557 · MQV
Etex Corp.
Orthopedic · 27d
Cleared Jul 01, 2010
NEV'S INK AUTOCLAVE TAPES
K101580 · JOJ
Nev'S Ink, Inc.
General Hospital · 24d
Cleared Jul 01, 2010
THERMODILUTION CATHETER
K101669 · DQO
Biosensors Intl. Pte. , Ltd.
Cardiovascular · 17d
Cleared Jul 01, 2010
IP-SET
K101685 · DRX
Integral Process Sas
Cardiovascular · 15d
Cleared Jul 01, 2010
CERULEAU ELECTROSURGICAL PROBE
K101711 · GEI
Nuortho Surgical, Inc.
General & Plastic Surgery · 13d
Cleared Jun 30, 2010
HANSON MEDICAL FACIAL IMPLANTS
K090803 · FZE
Hanson Medical, Inc.
General & Plastic Surgery · 463d
Cleared Jun 30, 2010
S-LIF INTERVERTEBRAL BODY FUSION DEVICE
K092815 · MAX
Spinefrontier, Inc.
Orthopedic · 289d
Cleared Jun 30, 2010
LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70
K093993 · OGZ
Infraredx, Inc.
Cardiovascular · 188d
Cleared Jun 30, 2010
PEEK PREVAIL CERVICAL INTERBODY DEVICE
K094042 · OVE
Medtronic Sofamor Danek
Orthopedic · 182d
Cleared Jun 30, 2010
TYCHE PEDICLE SCREW SYSTEM
K100373 · MNH
Kyung Won Medical Co., Ltd.
Orthopedic · 138d
Cleared Jun 30, 2010
UROSKOP OMNIA
K101491 · JAA
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Jun 30, 2010
APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810,...
K101575 · LPH
Omnlife Science
Orthopedic · 23d