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
33073–33096 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 2016
GluStitch Twist Tissue Adhesive
K150032 · MPN
Glustitch, Inc.
General & Plastic Surgery · 371d
Cleared Jan 14, 2016
ATLANTIS Abutment for NobelActive 3.0
K151039 · NHA
Dentsply International, Inc.
Dental · 269d
Cleared Jan 14, 2016
Cronus HP - High Pressure Peripheral Balloon Catheter
K151141 · LIT
Nipro Medical Corporation
Cardiovascular · 260d
Cleared Jan 14, 2016
ARIX Wrist System
K151468 · HRS
Jeil Medical Corporation
Orthopedic · 227d
Cleared Jan 14, 2016
Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose...
K151487 · CFR
Diatron U.S., Inc.
Chemistry · 226d
Cleared Jan 14, 2016
Rainbow Shine
K151842 · EIH
Genoss
Dental · 191d
Cleared Jan 14, 2016
Rainbow LS Pressing
K151846 · EIH
Genoss
Dental · 191d
Cleared Jan 14, 2016
OptiOne Single-Head Contrast Delivery System with Pedestal
K152361 · IZQ
Liebel-Flarsheim Company, LLC
Cardiovascular · 147d
Cleared Jan 14, 2016
FORZA PTC Spacer System
K152475 · MAX
Orthofix, Inc.
Orthopedic · 136d
Cleared Jan 14, 2016
LipiView II Ocular Surface Interferometer
K152869 · HKI
Tearscience, Inc.
Ophthalmic · 106d
Cleared Jan 14, 2016
Aequalis Fx2
K152966 · PHX
Tornier S.A.S.
Orthopedic · 99d
Cleared Jan 14, 2016
Amendia Stand-Alone Cervical System
K152972 · OVE
Amendia, Inc.
Orthopedic · 98d
Cleared Jan 14, 2016
Turbett Surgical Container
K153025 · FRG
Turbett Surgical, LLC
General Hospital · 90d
Cleared Jan 14, 2016
Tiger Cannulated Screw System
K153338 · HWC
Trilliant Surgical, Ltd.
Orthopedic · 56d
Cleared Jan 14, 2016
Spine Innovation Interbody System
K153356 · MAX
Spine Innovation, LLC
Orthopedic · 55d
Cleared Jan 14, 2016
PillCam COLON 2 Capsule Endoscopy System
K153466 · PGD
Given Imaging , Ltd.
Gastroenterology & Urology · 44d
Cleared Jan 14, 2016
ebb Complete Tamponade System
K153591 · OQY
Clinical Innovations, LLC
Obstetrics & Gynecology · 29d
Cleared Jan 14, 2016
Spectra Optia Apheresis System
K153601 · LKN
Terumobct, Inc.
Gastroenterology & Urology · 29d
Cleared Jan 13, 2016
TheraVision Ultrasound Ablation System and ACOUSTx Applicators
K150019 · NTB
Acoustic Medsystems, Inc.
General & Plastic Surgery · 373d
Cleared Jan 13, 2016
Sonishield 100 Antimicrobial Ultrasound Gel
K151070 · MUI
Quotient Medical
Radiology · 267d
Cleared Jan 13, 2016
VerteLP Interbody Fusion Device
K151312 · OVD
Vgi, LLC
Orthopedic · 240d
Cleared Jan 13, 2016
BioHorizons CAD/CAM Abutments
K151621 · NHA
BioHorizons Implant Systems, Inc.
Dental · 211d
Cleared Jan 13, 2016
STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
K151725 · MLR
Advanced Sterilization Products
General Hospital · 201d
Cleared Jan 13, 2016
LL TENS 160A, LL TENS 160B
K152374 · NUH
Fuji Dynamics , Ltd.
Neurology · 145d