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
33937–33960 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 2015
Bluefin Interbody System
K143479 · MAX
Tides Medical
Orthopedic · 291d
Cleared Sep 25, 2015
Endoluminal Occlusion System-EOS
K150402 · KRD
Artventive Medical Group, Inc.
Cardiovascular · 219d
Cleared Sep 25, 2015
U2 Total Knee System- Additional Sizes
K150829 · JWH
United Orthopedic Corporation
Orthopedic · 179d
Cleared Sep 25, 2015
U2 Femoral Component, CR, Porous Coated, Additional Sizes
K150832 · MBH
United Orthopedic Corporation
Orthopedic · 179d
Cleared Sep 25, 2015
DePuy Actis Duofox Hip Prosthesis
K150862 · MEH
DePuy Orthopaedics, Inc.
Orthopedic · 177d
Cleared Sep 25, 2015
AZUR CX Detachable 35 Coils
K151358 · KRD
MicroVention, Inc.
Cardiovascular · 128d
Cleared Sep 25, 2015
NuVasive X-CORE Mini Cervical Expandable VBR System
K151651 · PLR
Nu Vasive, Incorporated
Orthopedic · 99d
Cleared Sep 25, 2015
Alere Afinion HbA1c, Alere Afinion AS100 Analyzer
K151809 · LCP
Alere Technologies AS
Chemistry · 85d
Cleared Sep 25, 2015
X-spine Pedicle Screw System
K152132 · MNI
X-Spine Systems, Inc.
Orthopedic · 56d
Cleared Sep 25, 2015
Renovis Anterior Cervical Plate System
K152193 · KWQ
Renovis Surgical Technologies, Inc.
Orthopedic · 51d
Cleared Sep 25, 2015
BiowaveHOME Neuromodulation Pain Therapy Device
K152437 · GZJ
Biowave Corporation
Neurology · 29d
Cleared Sep 24, 2015
neon3
K150650 · NKG
Ulrich GmbH & Co. KG
Orthopedic · 196d
Cleared Sep 24, 2015
U & U Intravascular Administration Set
K151151 · FPA
U&U Medical Technology Co, Ltd.
General Hospital · 147d
Cleared Sep 24, 2015
Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis
K151293 · KWS
Tornier S.A.S.
Orthopedic · 132d
Cleared Sep 24, 2015
Gemmed pedicle screw spinal system
K151592 · MNI
Suzhou Gemmed Medical Instrument Co.,...
Orthopedic · 104d
Cleared Sep 24, 2015
Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet
K151786 · CDD
Roche Diagnostics
Chemistry · 85d
Cleared Sep 24, 2015
iHealth BP3L Wireless Blood Pressure Monitor
K152003 · DXN
Andon Health Co, Ltd.
Cardiovascular · 66d
Cleared Sep 24, 2015
Astringedent Clear
K152064 · MVL
Ultradent Products, Inc.
Dental · 62d
Cleared Sep 24, 2015
Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy...
K152069 · FGE
Navilyst Medical, Inc.
Gastroenterology & Urology · 59d
Cleared Sep 24, 2015
Metacross OTW PTA Balloon Dilatation Catheter
K152080 · LIT
KANEKA Corporation
Cardiovascular · 59d
Cleared Sep 24, 2015
SudoC
K152216 · GZO
Ld Technology, LLC
Neurology · 48d
Cleared Sep 24, 2015
Pyrenees Cervical Plate System
K152281 · KWQ
K2m
Orthopedic · 43d
Cleared Sep 24, 2015
Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC
K152409 · LJS
Navilyst Medical, Inc.
General Hospital · 29d
Cleared Sep 24, 2015
VITROS Chemistry Products CRP Slides
K152433 · DCK
Ortho-Clinical Diagnostics
Immunology · 28d