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
35569–35592 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 2015
LITe Plate System
K150449 · KWQ
Stryker Corp.
Orthopedic · 28d
Cleared Mar 19, 2015
MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES
K141042 · LYY
Mercator Medical (Thailand), Ltd.
General Hospital · 330d
Cleared Mar 19, 2015
Blackford Analysis Registration Product Family
K142337 · LLZ
Blackford Analysis, Ltd.
Radiology · 210d
Cleared Mar 19, 2015
IS4/DF4 Port Plug
K143463 · DTD
Oscor, Inc.
Cardiovascular · 105d
Cleared Mar 19, 2015
BioMonitor
K143503 · MXD
Biotronik, Inc.
Cardiovascular · 99d
Cleared Mar 19, 2015
Imbibe Aspirating XIA Taps
K143546 · KNW
Stryker Corporation
Gastroenterology & Urology · 94d
Cleared Mar 19, 2015
Treace Medical Concepts(TMC) Plating System
K143717 · HRS
Treace Medical Concepts, Inc.
Orthopedic · 80d
Cleared Mar 19, 2015
Aquilion LB, TSX-201A/3, V6.0
K150003 · JAK
Toshibamedical Systems Corporation
Radiology · 76d
Cleared Mar 19, 2015
NMI PICC III and NMI PICC IV
K150448 · LJS
Navilyst Medical, Inc.
General Hospital · 27d
Cleared Mar 18, 2015
COOK HOLMIUM LASER FIBER
K133788 · GEX
Cook Incorporated
General & Plastic Surgery · 461d
Cleared Mar 18, 2015
SYNTEC WETALI ORTHODONTIC MINI SCREWS
K142001 · OAT
Syntec Scientific Corporation -...
Dental · 238d
Cleared Mar 18, 2015
DMRC Self-Cure Bracket Adhesive One Step and Primer
K142886 · DYH
Danville Materials, LLC
Dental · 167d
Cleared Mar 18, 2015
TULIP Natural Rubber Latex Surgeon's Glove (Powdered)
K142992 · KGO
Shanghai Jinxiang Latex Products Co.,...
General Hospital · 153d
Cleared Mar 18, 2015
Penumbra Smart Coil
K143218 · HCG
Penumbra, Inc.
Neurology · 128d
Cleared Mar 18, 2015
PeriCoach
K143580 · HIR
Analytica, Ltd.
Gastroenterology & Urology · 90d
Cleared Mar 18, 2015
U-Lite
K143601 · IYN
Sonoscanner Sarl
Radiology · 90d
Cleared Mar 18, 2015
Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack
K143651 · PGX
Focus Diagnostics, Inc.
Microbiology · 85d
Cleared Mar 18, 2015
NICAL SMART MICRO CR system for intraoral dental images
K143703 · MUH
Nical Spa
Radiology · 79d
Cleared Mar 17, 2015
Evolve UniPolar Head
K143184 · KWL
Signature Orthopaedics Pty, Ltd.
Orthopedic · 132d
Cleared Mar 17, 2015
Assurance Alar / Nasal SpO2 Sensor
K143216 · DQA
Xhale, Inc.
Anesthesiology · 127d
Cleared Mar 17, 2015
AmpliVue Trichomonas Assay
K143329 · OUY
Quidel Corporation
Microbiology · 117d
Cleared Mar 17, 2015
MiroCam Capsule Endoscope System
K143663 · NEZ
Intromedic Co., Ltd.
Gastroenterology & Urology · 84d
Cleared Mar 16, 2015
ARTEMIS LIGHT ENGINE
K141164 · NTN
Quest Medical Imaging
Gastroenterology & Urology · 315d
Cleared Mar 16, 2015
EASYDRILL AUTOSTOP CRANIAL PERFORATOR
K141455 · HBF
Micromar Ind. Com. , Ltd.
Neurology · 287d