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
34057–34080 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 2015
MAMMOMAT Fusion
K151645 · MUE
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Sep 14, 2015
LOGIQ E9, LOGIQ E9 XDClear 2.0
K152309 · IYN
GE Medical Systems Ultrasound and...
Radiology · 31d
Cleared Sep 11, 2015
CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector
K143359 · DSI
Lifewatch Technologies , Ltd.
Cardiovascular · 291d
Cleared Sep 11, 2015
J+PRAS YOUNG'S Thread
K143413 · NEW
Y. Jacobs Medical, Inc.
General & Plastic Surgery · 287d
Cleared Sep 11, 2015
AQUA CLEANSE
K150381 · KPL
Quality Medical Supply, Inc.
Gastroenterology & Urology · 205d
Cleared Sep 11, 2015
CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System
K150619 · ODP
Orthofix, Inc.
Orthopedic · 185d
Cleared Sep 11, 2015
Straumann Variobase for CEREC
K151324 · NHA
Straumann USA, LLC
Dental · 116d
Cleared Sep 11, 2015
Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC...
K151368 · LKN
Terumo Bct
Gastroenterology & Urology · 113d
Cleared Sep 11, 2015
QuickPlan
K151560 · MUJ
Siris Medical
Radiology · 93d
Cleared Sep 11, 2015
23ga Chandelier Illuminator, 25ga Chandelier Illuminator
K151604 · MPA
Peregrine Surgical , Ltd.
Ophthalmic · 88d
Cleared Sep 11, 2015
Tissue Removal System
K151990 · GCJ
Boehringer Laboratories, LLC
General & Plastic Surgery · 53d
Cleared Sep 11, 2015
Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel...
K152018 · JAQ
Varian Medical Systems, Inc.
Radiology · 52d
Cleared Sep 11, 2015
CT Sim Laser System
K152303 · IWE
Gammex, Inc.
Radiology · 28d
Cleared Sep 10, 2015
HS AMICA DEVICES FAMILY
K150112 · GEI
H.S Hospital Service S.P.A
General & Plastic Surgery · 233d
Cleared Sep 10, 2015
Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier
K150840 · FZP
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 164d
Cleared Sep 10, 2015
Sutter Bipolar Forceps-Calvian
K150959 · GEI
Sutter Medizintechnik GmbH
General & Plastic Surgery · 153d
Cleared Sep 10, 2015
Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design
K151112 · GAW
Angiotech
General & Plastic Surgery · 135d
Cleared Sep 10, 2015
Amendia Interbody Fusion Devices
K151322 · MAX
Amendia, Inc.
Orthopedic · 115d
Cleared Sep 10, 2015
SONON Ultrasound Imaging System (Model: SONON 300C)
K151339 · IYO
Healcerion Co., Ltd.
Radiology · 114d
Cleared Sep 10, 2015
Keeler Slit Lamp
K151394 · HJO
Keeler Limited
Ophthalmic · 107d
Cleared Sep 10, 2015
NuVasive CoRoent Lumbar System
K151472 · MAX
Nu Vasive, Incorporated
Orthopedic · 101d
Cleared Sep 10, 2015
Zone, ZoneFree, Zone A1
K151526 · EMA
Sybron Dental Specialties
Dental · 94d
Cleared Sep 10, 2015
Valleylab FT10 Electrosurgical Platform
K151649 · GEI
Covidien
General & Plastic Surgery · 84d
Cleared Sep 10, 2015
Romeo posterior osteosynthesis system
K151695 · MNH
Spineart
Orthopedic · 79d