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
31273–31296 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 26, 2016
Vitalograph Model 6300 micro
K160253 · BZG
Vitalograph (Ireland) , Ltd.
Anesthesiology · 207d
Cleared Aug 26, 2016
Freedom Spinal Cord Stimulator System
K160600 · GZB
Stimwave Technologies Incorporated
Neurology · 177d
Cleared Aug 26, 2016
ORTHODONTIC CERAMIC BRACKETS 1.1
K160615 · NJM
Tomy, Inc.
Dental · 176d
Cleared Aug 26, 2016
FMX314 Surgical Platform
K160797 · OTJ
Fortimedix Surgical B.V.
General & Plastic Surgery · 156d
Cleared Aug 26, 2016
Bite Away
K160943 · IRT
Riemser Pharma
Physical Medicine · 143d
Cleared Aug 26, 2016
ATLANTIS Abutment for CONELOG implant
K161030 · NHA
Dentsply Sirona
Dental · 135d
Cleared Aug 26, 2016
EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear
K161124 · LPL
Vision Science Co., Ltd.
Ophthalmic · 127d
Cleared Aug 26, 2016
ORION
K161503 · GEX
Yerim Engineering Co., Ltd.
General & Plastic Surgery · 86d
Cleared Aug 26, 2016
Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe...
K161545 · HIS
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 84d
Cleared Aug 26, 2016
RS80A Diagnostic Ultrasound System
K162094 · IYN
Samsung Medison Co., Ltd.
Radiology · 29d
Cleared Aug 25, 2016
V10
K152659 · DXN
Mediana Co., Ltd.
Cardiovascular · 343d
Cleared Aug 25, 2016
HQS Introducer (Model 2064-HQS)
K153494 · DYB
Alseal
Cardiovascular · 265d
Cleared Aug 25, 2016
Optilite Low Level Albumin Kit
K153560 · DCF
The Binding Site Group , Ltd.
Immunology · 255d
Cleared Aug 25, 2016
LifeFlow Rapid Infusion Device (LifeFlow Device)
K153731 · FPA
410 Medical Innovation, LLC
General Hospital · 241d
Cleared Aug 25, 2016
Exufiber Ag+
K160379 · FRO
Molnlycke Health Care Us, LLC
General & Plastic Surgery · 197d
Cleared Aug 25, 2016
AneurysmFlow
K160455 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 189d
Cleared Aug 25, 2016
LIAISON HAV IgM, LIAISON Control HAV IgM
K160650 · LOL
DiaSorin, Inc.
Microbiology · 170d
Cleared Aug 25, 2016
AirLife Autofill Humidification Chamber
K160764 · BTT
Carefusion 2200, Inc.
Anesthesiology · 157d
Cleared Aug 25, 2016
ASAHI Corsair Pro
K161126 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 126d
Cleared Aug 25, 2016
Integra TITAN Reverse Shoulder System
K161189 · PHX
Integra LifeSciences Corporation
Orthopedic · 120d
Cleared Aug 25, 2016
Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)
K161195 · HIS
M3 Global Enterprises, LLC
Obstetrics & Gynecology · 120d
Cleared Aug 25, 2016
NuVasive Lumbar Interbody Implants
K161230 · MAX
Nu Vasive, Incorporated
Orthopedic · 115d
Cleared Aug 25, 2016
invendoscopy E200 System
K161355 · FDF
Invendo Medical GmbH
Gastroenterology & Urology · 101d
Cleared Aug 25, 2016
DragonFly Surgical Drill System
K161376 · ERL
Grace Medical, Inc.
Ear, Nose, Throat · 99d