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
35377–35400 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 09, 2015
MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT
K150567 · DWF
Medtronic, Inc.
Cardiovascular · 34d
Cleared Apr 09, 2015
Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml
K150607 · NDN
Osseon, LLC
Orthopedic · 30d
Cleared Apr 08, 2015
HIDREX PSP1000
K133033 · EGJ
Hidrex GmbH
Physical Medicine · 559d
Cleared Apr 08, 2015
CONVENTUS PHS SYSTEM
K141737 · JDS
Conventus Orthopaedics, Inc.
Orthopedic · 285d
Cleared Apr 08, 2015
CD HORIZON Spinal System, IPC POWEREASE System
K143019 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 170d
Cleared Apr 08, 2015
BLUEPRINT Patient Specific Instrumentation
K143374 · KWS
Tornier S.A.S.
Orthopedic · 134d
Cleared Apr 08, 2015
SOMATOM Definition AS/AS+
K143400 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 131d
Cleared Apr 08, 2015
Exilite
K150051 · ONF
BTL Industries, Inc.
General & Plastic Surgery · 86d
Cleared Apr 08, 2015
NOVA Lite DAPI ANA Kit
K150155 · DHN
Inova Diagnostics, Inc.
Immunology · 75d
Cleared Apr 08, 2015
ELIAN Digital Diagnostic X-ray System
K150506 · KPR
Osko, Inc.
Radiology · 41d
Cleared Apr 08, 2015
AngioSculpt PTA Scoring Baloon Catheters
K150634 · PNO
Spectranetrics
Cardiovascular · 28d
Cleared Apr 08, 2015
Polyscrew Pedicle Screw System
K150647 · MNI
New Era Orthopedics, LLC
Orthopedic · 27d
Cleared Apr 07, 2015
SOLSTICE OCT System
K143249 · KWP
Life Spine, Inc.
Orthopedic · 146d
Cleared Apr 07, 2015
ACCLARENT SE Inflation Device
K150172 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 71d
Cleared Apr 07, 2015
SOLSTICE OCT System
K150229 · KWP
Life Spine, Inc.
Orthopedic · 64d
Cleared Apr 07, 2015
UltraVision 2 Diagnostic Ultrasound System
K150580 · IYO
Winprobe Corporation
Radiology · 29d
Cleared Apr 07, 2015
CR3 Keyless Split Sample Cup Morphine - Methamphetamine
K150602 · DNK
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 28d
Cleared Apr 06, 2015
ULTRASONIC SCALER
K140233 · ELC
Nanning Baolai Medical Instrument...
Dental · 431d
Cleared Apr 06, 2015
LUOFUCON SILVER FOAM DRESSING
K141619 · FRO
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 293d
Cleared Apr 06, 2015
PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME!
K141913 · NUC
Pjur Group Luxembourg S.A.
Obstetrics & Gynecology · 265d
Cleared Apr 06, 2015
Ziehm Vision RFD 3D
K142740 · OWB
Ziehm Imaging GmbH
Radiology · 194d
Cleared Apr 06, 2015
Trevo XP ProVue Retriever (6X25mm)
K143077 · NRY
Concentric Medical, Inc.
Neurology · 161d
Cleared Apr 06, 2015
Acumed Ankle Plating System
K143385 · HRS
Acumed, LLC
Orthopedic · 131d
Cleared Apr 06, 2015
SOMATOM Definition Edge
K143401 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 129d