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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
59737–59760 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 30, 2007
3I OSSEOTITE CERTAIN DENTAL IMPLANTS
K063341 · DZE
Implant Innovations, Inc.
Dental · 175d
Cleared Apr 30, 2007
EASY CURING PEN-STYLE LED CURING LIGHT
K063659 · EBZ
Dent Corp. Research & Development
Dental · 143d
Cleared Apr 30, 2007
AESCULAP RESORBABLE PIN, MODEL FR735
K070178 · MAI
Aesculap Implant System, Inc.
Orthopedic · 101d
Cleared Apr 30, 2007
CARBON DIOXIDE LIQUID STABLE REAGENT
K070251 · KHS
Pointe Scientific, Inc.,
Chemistry · 94d
Cleared Apr 30, 2007
TWILIGHT FULL FACE MASK
K070321 · BZD
Invacare Corp.
Anesthesiology · 87d
Cleared Apr 30, 2007
ZIRBLOCK
K070537 · EIH
Cdl Technologies, Inc.
Dental · 63d
Cleared Apr 30, 2007
DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)
K070552 · JIT
Dade Behring, Inc.
Immunology · 62d
Cleared Apr 30, 2007
MEDISIZE GOLD HEATER AND BOOSTER
K070714 · BTT
Medisize BV
Anesthesiology · 47d
Cleared Apr 30, 2007
PRESSX ZR
K070772 · EIH
Wieland Dental + Technik GmbH & Co. KG
Dental · 40d
Cleared Apr 27, 2007
FRAXEL III SR LASER SYSTEM AND ACCESSORIES
K063038 · GEX
Reliant Technologies, Inc.
General & Plastic Surgery · 207d
Cleared Apr 27, 2007
ARTHROCARE CAVITY SPINEWAND
K063172 · GEI
Arthrocare Corp.
General & Plastic Surgery · 191d
Cleared Apr 27, 2007
IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6)
K063328 · ITI
Imc-Heart Way LLC
Physical Medicine · 175d
Cleared Apr 27, 2007
OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION
K063503 · IZQ
Mallinckrodt Inc., Liebel-Flarsheim...
Cardiovascular · 158d
Cleared Apr 27, 2007
RUNTHROUGH NS
K063695 · DQX
Terumo Medical Corp.
Cardiovascular · 135d
Cleared Apr 27, 2007
OSSEOSPEED 4.0S-6MM, MODEL 24619
K063779 · DZE
Astra Tech, Inc.
Dental · 127d
Cleared Apr 27, 2007
PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T...
K063783 · DQA
Philips Medical Systems, Inc.
Anesthesiology · 127d
Cleared Apr 27, 2007
FRAXEL IV SR LASER SYSTEM
K063808 · GEX
Reliant Technologies, Inc.
General & Plastic Surgery · 126d
Cleared Apr 27, 2007
UNIVERSAL SURGICAL MESH, MODEL 100
K070018 · FTL
Generic Medical Device, Inc.
General & Plastic Surgery · 114d
Cleared Apr 27, 2007
COOK MICROWIRE WIRE GUIDE
K070410 · DQX
Cook, Inc.
Cardiovascular · 74d
Cleared Apr 27, 2007
MODIFICATION TO AQUADEX FLEXFLOW SYSTEM
K070512 · KDI
Chf Solutions, Inc.
Gastroenterology & Urology · 64d
Cleared Apr 27, 2007
INOMAX DS (DELIVERY SYSTEM), MODEL 10003
K070867 · MRN
Ino Therapeutics, LLC
Anesthesiology · 29d
Cleared Apr 27, 2007
STRYKER TWIST DRILLS
K070876 · HBE
Stryker Craniomaxillofacial
Neurology · 29d
Cleared Apr 27, 2007
MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER
K071011 · MWJ
Braemar, Inc.
Cardiovascular · 17d
Cleared Apr 27, 2007
DIGITAL CLINICAL THERMOMETER/MODELS ST8C SERIES
K071019 · FLL
Mesure Technology Co., Ltd.
General Hospital · 17d