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
38065–38088 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 2014
OPTOSSOL COMPRESSION DEVICE SYSTEM
K140875 · JDW
Genossis, LLC
Orthopedic · 56d
Cleared May 30, 2014
SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT
K141124 · DSY
Vascular Flow Technologies, Ltd.
Cardiovascular · 29d
Cleared May 30, 2014
SURFLASH SAFETY I.V. CATHETER
K141138 · FOZ
Kofu Factory of Terumo Corp.
General Hospital · 28d
Cleared May 29, 2014
SENTIO MMG
K131304 · PDQ
Innovative Surgical Solutions, LLC...
Neurology · 387d
Cleared May 29, 2014
URS-2GP (GLUCOSE PROTEIN) URINE STRIPS
K131600 · JIL
Teco Diagnostics
Chemistry · 360d
Cleared May 29, 2014
MEDI PEN NEEDLE
K131954 · FMI
Shanghai Carelife International...
General Hospital · 336d
Cleared May 29, 2014
SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY
K132506 · LRK
Michael D Williams Dds PA
Dental · 290d
Cleared May 29, 2014
PEEK CAGE FOR THE VERTEBRAL SPINE
K132852 · MAX
Neoortho Produtos Ortopedicos S/A
Orthopedic · 260d
Cleared May 29, 2014
MOVES SLC
K140049 · BTL
Thornhill Research, Inc.
Anesthesiology · 140d
Cleared May 29, 2014
S.E.A.L. FRACTURE FUSION TUBE
K140158 · KTT
Dne, LLC
Orthopedic · 127d
Cleared May 29, 2014
KOALA TOCO
K140163 · HFM
Clinical Innovations, LLC
Obstetrics & Gynecology · 127d
Cleared CT May 29, 2014
NIGHT SHIFT
K140190 · MYB
Advanced Brain Monitoring, Inc.
Ear, Nose, Throat · 125d
Cleared May 29, 2014
XGEO GF50
K140326 · KPR
Samsung Electronics Co., Ltd.
Radiology · 108d
Cleared May 29, 2014
JOURNEY II BCS CONSTRAINED INSERTS
K140555 · JWH
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared May 29, 2014
VARIAX 2 COMPRESSION PLATING SYSTEM
K140565 · HRS
Stryker Trauma AG
Orthopedic · 85d
Cleared May 29, 2014
DRIVE RAIL SYSTEM
K140822 · KTT
Devise Ortho, Inc.
Orthopedic · 58d
Cleared May 28, 2014
VALENTINE STEEL WHEELCHAIR
K130017 · IOR
Valentine Intl. , Ltd.
Physical Medicine · 511d
Cleared May 28, 2014
CLEARVIEW TOTAL
K131781 · LKF
Clinical Innovations, LLC
Obstetrics & Gynecology · 345d
Cleared May 28, 2014
REHASTIM 2, ERIGOPRO (FES)
K132416 · GZI
Hasomed GmbH
Neurology · 299d
Cleared May 28, 2014
IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY
K132801 · DHB
Siemens Healthcare Diagnostics, Inc.
Immunology · 257d
Cleared May 28, 2014
ELASTIC IMPRESSION MATERIAL
K133071 · ELW
Rizhao Huge Dental Industry Co., Ltd.
Dental · 240d
Cleared May 28, 2014
SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA....
K133316 · BSO
Epimed International, Inc.
Anesthesiology · 212d
Cleared CT May 28, 2014
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)
K133481 · MXC
St. Jude Medical, Inc.
Cardiovascular · 196d
Cleared May 28, 2014
A-DEC/W&H ELECTRIC HANDPIECE MOTOR
K133776 · EBW
A-Dec, Inc.
Dental · 167d