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
32017–32040 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 26, 2016
Mariner Pedicle Screw System
K160902 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 55d
Cleared May 26, 2016
Threshold Pedicular Fixation System, Palisade Pedicular Fixation System
K160980 · NKB
Spineology, Inc.
Orthopedic · 49d
Cleared May 26, 2016
Seal Single-Use Biopsy Valve
K161167 · OCX
Endochoice, Inc.
Gastroenterology & Urology · 30d
Cleared May 26, 2016
G7 Dual Mobility System, Active Articulation System
K161190 · LPH
Biomet, Inc.
Orthopedic · 29d
Cleared May 26, 2016
Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug
K161221 · FTM
Cook Biotech Incorporated
General & Plastic Surgery · 27d
Cleared May 26, 2016
Radiance Ultra Series ZeroWire Embedded
K161228 · GCJ
Nds Surgical Imaging, LLC
General & Plastic Surgery · 24d
Cleared May 25, 2016
ActTrust
K151784 · LEL
Condor Instruments Ltda. - Epp
Neurology · 329d
Cleared May 25, 2016
FLEX SCORING CATHETER
K152789 · PNO
Venturemed Group
Cardiovascular · 243d
Cleared May 25, 2016
Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body...
K153026 · IYE
Medtec, Inc. D/B/A Civco Medical...
Radiology · 222d
Cleared May 25, 2016
Stryker Orthopaedics Hip Systems Labeling Update
K153345 · LPH
Stryker Orthopaedics
Orthopedic · 188d
Cleared May 25, 2016
EMMa Electronic Monitoring Management
K153477 · DSI
Vitasystems GmbH
Cardiovascular · 175d
Cleared May 25, 2016
Prometheus ChitoGauze XR PRO
K153582 · QSY
Hem Con Medical Technologies, Inc.
General & Plastic Surgery · 162d
Cleared May 25, 2016
ArcadiusXP C Spinal System
K153629 · OVE
Aesculap Implant Systems, Inc.
Orthopedic · 159d
Cleared May 25, 2016
PIEZOSURGERY PLUS
K153743 · JDX
Mectron S.P.A.
Orthopedic · 149d
Cleared May 25, 2016
Smartdop XT6
K153762 · JOP
Koven Technology, Inc.
Cardiovascular · 147d
Cleared May 25, 2016
Penumbra System, Penumbra Pump MAX
K160449 · NRY
Penumbra, Inc.
Neurology · 97d
Cleared May 25, 2016
Creatine Kinase
K160570 · JHS
Roche Diagnostics Operations (Rdo)
Chemistry · 86d
Cleared May 24, 2016
Hypocore
K153162 · NCX
Novocor Medical Systems, Inc.
Neurology · 204d
Cleared May 24, 2016
Haemonetics Cell Saver Elite Autotransfusion System
K160197 · CAC
Haemonetics Corporation
Anesthesiology · 118d
Cleared May 24, 2016
Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)
K160533 · QEW
Penumbra, Inc.
Cardiovascular · 96d
Cleared May 24, 2016
CROSSER CTO Recanalization Catheter
K161208 · PDU
Bard Peripheral Vacular, Inc.
Cardiovascular · 26d
Cleared May 23, 2016
PINPOINT Endoscopic Fluorescence Imaging System
K150956 · GCJ
Novadaq Technologies, Inc.
General & Plastic Surgery · 410d
Cleared May 23, 2016
Agem Ag Mesh Dressing with Silver
K152544 · FRO
Shenzhen Yuanxing Nano-Pharma Co., Ltd.
General & Plastic Surgery · 262d
Cleared May 23, 2016
INCLUSIVE TAPERED IMPLANT SYSTEM
K153099 · DZE
Prismatik Dentalcraft, Inc.
Dental · 210d