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
50353–50376 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 26, 2010
HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34
K101142 · INI
Heartway Medical Products Co., Ltd.
Physical Medicine · 34d
Cleared May 26, 2010
HEARTWAY POWER MOBILITY SCOOTER, S11
K101143 · INI
Heartway Medical Products Co., Ltd.
Physical Medicine · 34d
Cleared May 25, 2010
CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)
K092021 · OHA
Cryolife, Inc.
Cardiovascular · 323d
Cleared May 25, 2010
HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL...
K093390 · LYC
Depuy Spine, Inc.
Dental · 208d
Cleared May 25, 2010
PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES
K093405 · MBH
Wrightmedicaltechnologyinc
Orthopedic · 204d
Cleared May 25, 2010
CERAMICS2IN1
K100150 · EIH
Biodenta Swiss AG
Dental · 126d
Cleared May 25, 2010
BLOOD PRESSURE METER MODEL CH-101
K100553 · DXN
Citizen Systems Japan Co., Ltd.
Cardiovascular · 88d
Cleared May 25, 2010
MECHANICAL WHEELCHAIR, MODEL DS 202-S
K100824 · IOR
Suzhou KD Medical
Physical Medicine · 62d
Cleared May 24, 2010
EVERON 1.0
K092062 · BZQ
Earlysense, Ltd.
Anesthesiology · 320d
Cleared May 24, 2010
SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500
K100148 · OQW
Focus Diagnostics, Inc.
Microbiology · 125d
Cleared May 24, 2010
POLYTEL(R) APT MODEL: PWA-08-01
K100524 · DRG
Polymap Wireless, LLC
Cardiovascular · 89d
Cleared May 24, 2010
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL
K101011 · DQX
Abbott Vascular, Inc.
Cardiovascular · 42d
Cleared May 21, 2010
MAMBO, MODEL CS 18XX-XX
K090861 · KWQ
Ulrich GmbH & Co. KG
Orthopedic · 417d
Cleared May 21, 2010
HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I
K091556 · MSV
Instrumentation Laboratory CO
Immunology · 359d
Cleared May 21, 2010
SONIC SHOT GX
K091734 · IZQ
Nemoto Kyorindo Co., Ltd.
Radiology · 344d
Cleared May 21, 2010
VITEK 2 YEAST VORICONAZOLE
K092454 · NGZ
bioMerieux, Inc.
Microbiology · 284d
Cleared May 21, 2010
BIOMET FORERUNNER LOCKING PLATE SYSTEM
K092528 · HRS
Biomet Trauma (Aka Ebi, Lp)
Orthopedic · 276d
Cleared May 21, 2010
TRANSCORP TRANS-PLATE ANTERIOR CERVICAL PLATE SYSTEM
K092695 · KWQ
Transcorp, Inc.
Orthopedic · 261d
Cleared May 21, 2010
MEDIFLASH AND ESTEFLASH
K093168 · ONF
Dermeo
General & Plastic Surgery · 226d
Cleared May 21, 2010
FIXCET SPINAL FACET SCREW SYSTEM
K100154 · MRW
X-Spine Systems, Inc.
Orthopedic · 121d
Cleared May 21, 2010
LUMINESSE ZR BLANKS
K100232 · EIH
Talladium, Inc.
Dental · 115d
Cleared May 21, 2010
VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER
K100349 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 98d
Cleared May 21, 2010
ULTRA DCI MODEL 5000
K100363 · IYO
Ultrasound Medical Devices, Inc.
Radiology · 98d
Cleared May 21, 2010
DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200
K100626 · KNG
Shenzhen Biocare Electronics Co., Ltd.
Radiology · 77d