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
38473–38496 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 11, 2014
RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE
K132138 · PDQ
Rhythmlink International, LLC
Neurology · 274d
Cleared Apr 11, 2014
RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM
K132312 · LPH
Renovis Surgical Technologies, LLC
Orthopedic · 260d
Cleared Apr 11, 2014
AIR-FLOW HANDY 3.0
K132478 · EFB
E.M.S Electro Medical Systems S.A
Dental · 246d
Cleared Apr 11, 2014
PROPOSED OPTIMUS
K132596 · OVD
Custom Spine, Inc.
Orthopedic · 235d
Cleared Apr 11, 2014
SPINEWORKS ANTERIOR LUMBAR DEVICE
K133340 · MAX
Spineworks, LLC
Orthopedic · 163d
Cleared Apr 11, 2014
REVEEL ENDOSCOPIC RETRACTOR
K133345 · GCJ
Retraction Limited
General & Plastic Surgery · 163d
Cleared Apr 11, 2014
AZE PHOENIX SOFTWARE
K133521 · LLZ
Aze, Ltd.
Radiology · 147d
Cleared Apr 11, 2014
REVOLUTION CT
K133705 · JAK
Ge Medical Systems, LLC
Radiology · 129d
Cleared Apr 11, 2014
DECLIPSESPECT LAPAROSCOPY
K133781 · IZD
Surgiceye GmbH
Radiology · 120d
Cleared Apr 11, 2014
MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET
K133923 · MUD
Reflectance Medical, Inc.
Cardiovascular · 109d
Cleared Apr 11, 2014
INION FREEDOMPIN
K133932 · HTY
Inion OY
Orthopedic · 109d
Cleared Apr 11, 2014
M-PM-DISC
K134015 · MQC
Merz Dental GmbH
Dental · 105d
Cleared Apr 11, 2014
DAYTONA ICG (P200TICG)
K134039 · MYC
Optos Plc.
Ophthalmic · 101d
Cleared Apr 11, 2014
JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND...
K134047 · HCZ
Integra LifeSciences Corporation
Obstetrics & Gynecology · 101d
Cleared Apr 11, 2014
GIBRALT ROD-TO-ROD CROSS CONNECTORS
K140645 · KWP
Exactech Sarasota
Orthopedic · 29d
Cleared Apr 11, 2014
DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G
K140646 · MQB
Rayence Co., Ltd.
Radiology · 29d
Cleared Apr 10, 2014
PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)
K131028 · EOQ
Pentax Medical Company
Ear, Nose, Throat · 363d
Cleared Apr 10, 2014
PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)
K131902 · FDS
Pentax Medical Company
Gastroenterology & Urology · 289d
Cleared Apr 10, 2014
IEEG
K131944 · OMC
Jordan Neuroscience, Inc.
Neurology · 287d
Cleared Apr 10, 2014
ONTEX AND OTHERS PROPRIETARY NAMES
K132208 · HIL
Ontex Bvba
Obstetrics & Gynecology · 268d
Cleared Apr 10, 2014
VECTRA NEO CLINICAL THERAPY SYSTEM
K132284 · IPF
Djo, LLC
Physical Medicine · 261d
Cleared Apr 10, 2014
SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES
K132290 · PBF
Materialise NV
Orthopedic · 261d
Cleared Apr 10, 2014
RETROMTA-ORTHOMTA II
K132825 · KIF
Biomta
Dental · 213d
Cleared Apr 10, 2014
MULTIX SELECT DR
K132934 · KPR
Siemens Medi Cal Solutions, Inc.
Radiology · 204d