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
42217–42240 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 2013
POINT 500 HD POINT500C HD
K121800 · MUH
Pointnix Co., Ltd.
Radiology · 219d
Cleared Jan 24, 2013
VITRA MULTISPOT
K122251 · GEX
Quantel Medical
General & Plastic Surgery · 181d
Cleared Jan 24, 2013
SUREFLEX STEERABLE GUIDING SHEATH KIT
K122926 · DYB
Baylis Medical Co., Inc.
Cardiovascular · 122d
Cleared Jan 24, 2013
VASHE SKIN AND WOUND HYDROGEL
K123071 · FRO
Puricore, Inc.
General & Plastic Surgery · 115d
Cleared Jan 24, 2013
SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO...
K123304 · EBF
Ivoclar Vivadent, AG
Dental · 92d
Cleared Jan 24, 2013
Medafor Direct Gas-Assisted Application System
K123325 · GCJ
Medafor, Inc.
General & Plastic Surgery · 90d
Cleared Jan 24, 2013
REPROCESSED STEERABLE INTRODUCER
K123334 · DYB
Stryker Sustainability Solutions, Inc.
Cardiovascular · 90d
Cleared Jan 23, 2013
HEPAIRX VENTILATING AIR PURIFIER
K112728 · FRF
Air Innovations, Inc.
General Hospital · 491d
Cleared Jan 23, 2013
OSSEOSPEED ANGLED ABUTMENT EV
K121810 · NHA
Astra Tech AB
Dental · 217d
Cleared Jan 23, 2013
MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML
K121964 · NEU
Augmenix, Inc.
General & Plastic Surgery · 202d
Cleared Jan 23, 2013
ENVITEC MYSIGN O OXYGEN MEASURING DEVICE
K122290 · CCL
Envitec-Wismar GmbH
Anesthesiology · 177d
Cleared Jan 23, 2013
ACCULIF TL-PEEK CAGE
K123281 · MAX
Coalign Innovations, Inc.
Orthopedic · 93d
Cleared Jan 23, 2013
FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)
K123310 · GEI
Utah Medical Products, Inc.
General & Plastic Surgery · 90d
Cleared Jan 23, 2013
GAMMA3 AND T2 RECON TARGETING DEVICES
K123401 · HSB
Stryker Trauma AG
Orthopedic · 79d
Cleared Jan 23, 2013
FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL
K123579 · MBI
Smith & Nephew, Inc.
Orthopedic · 65d
Cleared Jan 23, 2013
DURABLUE STERILIZATION WRAP
K123857 · FRG
Cardinal Health200, LLC
General Hospital · 40d
Cleared Jan 23, 2013
TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+
K123982 · KWS
Encore Medical, L.P.
Orthopedic · 28d
Cleared Jan 22, 2013
TBA
K121269 · FPA
Migada Plant
General Hospital · 271d
Cleared Jan 22, 2013
BACT/ALERT FA PLUS CULTURE BOTTLE
K121461 · MDB
bioMerieux, Inc.
Microbiology · 250d
Cleared Jan 22, 2013
INTENSE PULSED LIGHT (IPL) SYSTEMS
K122995 · ONF
Beijing Kes Biology Technology Co., Ltd.
General & Plastic Surgery · 118d
Cleared Jan 22, 2013
AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA...
K123314 · DTZ
Medtronic, Inc.
Cardiovascular · 89d
Cleared Jan 22, 2013
SYNAPSE 3D COLON ANALYSIS
K123566 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 63d
Cleared Jan 22, 2013
SYNGO.VIA MI WORKFLOWS
K123577 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 63d
Cleared Jan 22, 2013
PERMASORB DISPOSABLE FIXATION DEVICE
K123718 · GDW
C.R. Bard, Inc.
General & Plastic Surgery · 49d