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
33385–33408 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 2015
EmbryoSlide Culture Dish
K150961 · MQK
Vitrolife A/S
Obstetrics & Gynecology · 238d
Cleared Dec 04, 2015
HMB32
K150966 · KPO
Haemopharm Biofluids S.R.L.
Gastroenterology & Urology · 235d
Cleared Dec 04, 2015
Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle
K151936 · DYB
Synaptic Medical Limited
Cardiovascular · 143d
Cleared Dec 04, 2015
Implant Studio 2015
K152078 · LLZ
3Shape Medical A/S
Radiology · 130d
Cleared Dec 04, 2015
Upcera Dental Zirconia Blank for Aesthetic Restoration
K152175 · EIH
Liaoning Upcera Co., Ltd.
Dental · 122d
Cleared Dec 04, 2015
COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS
K152284 · HEB
Cotton High Tech S.L.
Obstetrics & Gynecology · 114d
Cleared Dec 04, 2015
kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone...
K152321 · IYE
Qfix
Radiology · 109d
Cleared Dec 04, 2015
Stingray LP Catheter
K152401 · DQY
Boston Scientific Corporation
Cardiovascular · 101d
Cleared Dec 04, 2015
KIRO Set
K152441 · LHI
Kiro Robotics S.L.
General Hospital · 99d
Cleared Dec 04, 2015
FastFrame External Fixation System - Distal Radius
K152484 · KTT
Zimmer, Inc.
Orthopedic · 95d
Cleared CT Dec 04, 2015
INEX Absorbable Nasal Implant
K152958 · NHB
Spirox, Inc.
Ear, Nose, Throat · 58d
Cleared Dec 04, 2015
NMI Port, NMI Port II
K153228 · LJT
Navilyst Medical, Inc.
General Hospital · 28d
Cleared Dec 03, 2015
Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert...
K151226 · OCC
Cepheid
Microbiology · 210d
Cleared Dec 03, 2015
Disposable Endoscope Valves Set A
K151714 · ODC
Wilson Instruments (Shanghai) Company...
Gastroenterology & Urology · 161d
Cleared Dec 03, 2015
CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
K152582 · DSK
Volcano Corporation
Cardiovascular · 84d
Cleared Dec 03, 2015
Portable X-ray System (Model: MINIX-V / MINIX-S)
K152859 · EHD
Digimed Co., Ltd. (Digimed...
Radiology · 64d
Cleared Dec 03, 2015
SYDNEY IVF EMBRYO BIOPSY MEDIUM
K152904 · MQL
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 63d
Cleared Dec 03, 2015
Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir
K153213 · DTZ
Terumo Cardiovascular Systems...
Cardiovascular · 28d
Cleared Dec 02, 2015
Reaxon Plus
K143711 · JXI
Medovent GmbH
Neurology · 338d
Cleared Dec 02, 2015
EnFocus 2300, EnFocus 4400
K150722 · HLI
Bioptigen, Inc.
Ophthalmic · 257d
Cleared Dec 02, 2015
Universal Spike
K150787 · LHI
B.Braun Medical, Inc.
General Hospital · 252d
Cleared Dec 02, 2015
Zero-P Natural Plate System
K152239 · KWQ
Synthes (Usa), LLC
Orthopedic · 114d
Cleared Dec 02, 2015
Attachable Cath Lab Hemostasis Valve
K152528 · DTL
Galt Medical Corp.
Cardiovascular · 90d
Cleared Dec 02, 2015
PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01,...
K152566 · MBI
Smith & Nephew, Inc.
Orthopedic · 84d