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

Filters: Cleared only ×
176,076 results
67873–67896 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 2004
MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM
K042514 · MNI
Blackstone Medical, Inc.
Orthopedic · 21d
Cleared Oct 07, 2004
EXAM-PACS
K042647 · LLZ
Coactiv, LLC
Radiology · 9d
Cleared Oct 07, 2004
CLARITY FUSION
K042692 · LLZ
Shared P.E.T. Imaging, LLC
Radiology · 7d
Cleared Oct 07, 2004
MODIFICATION TO MEDLINE STRIDER MIDI 3
K042763 · INI
Medline Industries, Inc.
Physical Medicine · 2d
Cleared Oct 06, 2004
LASEREX, MODEL LP4532
K041598 · HQF
Ellex Medical Pty, Ltd.
Ophthalmic · 114d
Cleared Oct 06, 2004
MPM SYSTEM
K041854 · DXN
Aerotel Medical Systems, Ltd.
Cardiovascular · 90d
Cleared Oct 06, 2004
VECTORVISION UNI-KNEE
K041899 · HAW
Brainlab AG
Neurology · 84d
Cleared Oct 06, 2004
MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM
K041994 · GEX
Curelight, Ltd.
General & Plastic Surgery · 75d
Cleared Oct 06, 2004
EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE
K042060 · DTL
Millimed A/S
Cardiovascular · 68d
Cleared Oct 06, 2004
CARDEON COBRA CATHETER
K042156 · DWF
Cardeon Corp.
Cardiovascular · 57d
Cleared Oct 06, 2004
SLEEPSENSE SLEEP SENSORS
K042253 · MNR
S.L.P. , Ltd.
Anesthesiology · 47d
Cleared Oct 06, 2004
STAT K IN VITRO DIAGNOSTIC TEST SYSTEM
K042270 · CEM
Stat Chem, Inc.
Chemistry · 44d
Cleared Oct 06, 2004
VACUUM ASSISTED CORE BIOPSY DEVICE
K042290 · KNW
Suros Surgical Systems, Inc.
Gastroenterology & Urology · 43d
Cleared Oct 06, 2004
VERIFYNOW-ASPIRIN ASSAY
K042423 · JOZ
Accumetrics, Inc.
Hematology · 29d
Cleared Oct 06, 2004
BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER
K042469 · MWJ
Braemar, Inc.
Cardiovascular · 23d
Cleared Oct 06, 2004
BALANCEBACK VNG SYSTEM
K042529 · GWN
Fall Prevention Technologies, LLC
Neurology · 19d
Cleared Oct 06, 2004
EQUI-FLOW VALVE AND SHUNT SYSTEM
K042558 · JXG
Integra Neurosciences Implants S.A.
Neurology · 15d
Cleared Oct 06, 2004
STELLAR 404 MONITORING SYSTEM
K042560 · MWI
Larsen & Toubro Limited
Cardiovascular · 15d
Cleared Oct 06, 2004
HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
K042609 · FRN
Hospira, Inc.
General Hospital · 12d
Cleared Oct 06, 2004
JAZZY 600
K042612 · ITI
Pride Mobility Products Corp.
Physical Medicine · 12d
Cleared Oct 06, 2004
INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5
K042656 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 8d
Cleared Oct 05, 2004
AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR
K041698 · MAI
Axya Medical, Inc.
Orthopedic · 105d
Cleared Oct 05, 2004
ACUMED ANATOMIC RADIAL HEAD SYSTEM
K041858 · KWI
Acumed, LLC
Orthopedic · 88d
Cleared Oct 05, 2004
PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT...
K042137 · KKX
Promedical Products Co., Ltd.
General Hospital · 57d