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

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176,076 results
57265–57288 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 29, 2008
ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT
K073540 · NHA
Atlantis Components, Inc.
Dental · 73d
Cleared Feb 29, 2008
EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW
K073688 · PHX
Exactech, Inc.
Orthopedic · 63d
Cleared Feb 29, 2008
ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM
K080176 · IYN
Aloka Co., Ltd.
Radiology · 36d
Cleared Feb 29, 2008
5.5 MM SUTURE LOCK BONE SCREW ANCHOR
K080229 · MBI
Kfx Medical
Orthopedic · 30d
Cleared Feb 29, 2008
HEART SYNC, MODELS C-100 AND T-100
K080421 · MKJ
Heart Sync, LLC
Cardiovascular · 14d
Cleared Feb 28, 2008
ELLMAN NOBLE ALLOY ELECTRODES
K071343 · GEI
Ellman International, Inc.
General & Plastic Surgery · 290d
Cleared Feb 28, 2008
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310
K072054 · NBW
Bionime Corporation
Chemistry · 217d
Cleared Feb 28, 2008
INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYS
K072211 · KCT
Intuitive Surgical, Inc.
General Hospital · 203d
Cleared Feb 28, 2008
SPECTRA MRSA
K073027 · JSO
Thermo Fisher Scientific
Microbiology · 125d
Cleared Feb 28, 2008
PETERIO UNIVERSAL LASER SCANNING HANDPIECE
K073048 · GEX
Scilex, Ltd.
General & Plastic Surgery · 122d
Cleared Feb 28, 2008
EBI INTERNAL IMPLANT SYSTEM
K073116 · DZE
Ebi, Inc.
Dental · 115d
Cleared Feb 28, 2008
LIMITED ARTIFACT SKULL PIN, MODEL 0107
K073163 · HBL
Dinkler Surgical Devices, Inc.
Neurology · 111d
Cleared Feb 28, 2008
ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL
K073191 · CJE
Thermofisher Scientific OY
Chemistry · 107d
Cleared Feb 28, 2008
SYGNAL DBM
K073329 · MBP
Musculoskeletal Transplant Foundation
Orthopedic · 93d
Cleared Feb 28, 2008
CALCIUM, SCAL, NORTROL, ABTROL
K073355 · CJY
Thermofisher Scientific OY
Chemistry · 91d
Cleared Feb 28, 2008
SMART COUPLER, MODEL M015401
K073384 · GWJ
Intelligent Hearing Systems
Neurology · 87d
Cleared Feb 28, 2008
PACIFICA
K073407 · MUD
Or-Nim Medical , Ltd.
Cardiovascular · 86d
Cleared Feb 28, 2008
CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES
K073459 · LPL
Ciba Vision Corporation
Ophthalmic · 80d
Cleared Feb 28, 2008
Q-PLUS T
K073549 · GEX
Quanta System Spa
General & Plastic Surgery · 72d
Cleared Feb 28, 2008
EEG NEUROAMP, MODEL CS10137
K073557 · HCC
Corscience GmbH & Co. KG
Neurology · 71d
Cleared Feb 28, 2008
AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE
K080006 · GEX
Cynosure, Inc.
General & Plastic Surgery · 57d
Cleared Feb 28, 2008
ENVOYCEM, MODEL 1640
K080032 · NEA
Envoy Medical Corporation
Ear, Nose, Throat · 52d
Cleared Feb 28, 2008
BEAUTIFIL OPAQUER
K080068 · EBF
Shofu Dental Corp.
Dental · 49d
Cleared Feb 28, 2008
VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM
K080107 · LON
bioMerieux, Inc.
Microbiology · 44d