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
35761–35784 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 20, 2015
EASY OUT
K141401 · HWC
Feet For Life Podiatry Center
Orthopedic · 268d
Cleared Feb 20, 2015
MEDENTIKA ABUTMENT SYSTEM
K142167 · NHA
Medentika GmbH
Dental · 198d
Cleared Feb 20, 2015
NuVasive X-CORE(R) Expandable VBR System
K142205 · MQP
Nuvasive, Inc.
Orthopedic · 193d
Cleared Feb 20, 2015
Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF...
K142248 · GEI
Urologix, Inc.
General & Plastic Surgery · 190d
Cleared Feb 20, 2015
StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician...
K142432 · GZF
Bioness, Inc.
Neurology · 175d
Cleared Feb 20, 2015
3S Safety Syringe with/without Needle
K142435 · MEG
Sincere Medical Device Co., Ltd.
General Hospital · 175d
Cleared Feb 20, 2015
U50 Diagnostic Ultrasound System
K142511 · IYN
Edan Instruments, Inc.
Radiology · 165d
Cleared Feb 20, 2015
ZywieAI Software Library
K142693 · DPS
Zywie, Inc.
Cardiovascular · 151d
Cleared Feb 20, 2015
Fingertip Pulse Oximeter
K142888 · DQA
Beijing Choice Electronic Technololgy...
Anesthesiology · 141d
Cleared CT Feb 20, 2015
Volcano iFR Harvest Software (Offline)
K143122 · IYO
Volcano Corporation
Radiology · 112d
Cleared Feb 20, 2015
Spring Coil Guidewire
K143135 · DQX
Neometrics, Inc.
Cardiovascular · 112d
Cleared Feb 20, 2015
IntelliSense Drill
K143191 · HWE
Mcginley Innovations
Orthopedic · 106d
Cleared Feb 20, 2015
Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and...
K143431 · LPL
I-Codi Co., Ltd.
Ophthalmic · 81d
Cleared Feb 20, 2015
KINETIS Total Knee System
K143635 · JWH
Mako Surgical
Orthopedic · 60d
Cleared Feb 20, 2015
NeedleCam HD Visualization System
K143705 · HRX
Biovision Technologies, LLC
Orthopedic · 53d
Cleared Feb 20, 2015
Bissinger Monopolar Cables
K150024 · GEI
Guenter Bissinger Medizintechnik GmbH
General & Plastic Surgery · 44d
Cleared Feb 20, 2015
Terason uSmart3300 Ultrasound System
K150148 · IYN
Teratech Corp.
Radiology · 28d
Cleared Feb 19, 2015
BUSSE EXTENSION SET
K141285 · FPA
Busse Hospital Disposables
General Hospital · 279d
Cleared Feb 19, 2015
ORAGENE DX OGD-500.001
K141410 · OYJ
DNA Genotek, Inc.
Chemistry · 266d
Cleared Feb 19, 2015
SYPHER SPACER SYSTEM
K141798 · OVD
Biogennix, LLC
Orthopedic · 231d
Cleared Feb 19, 2015
Osstell IDx
K142358 · EKX
Osstell AB
Dental · 178d
Cleared Feb 19, 2015
3S Safety Insulin Syringe
K142436 · MEG
Sincere Medical Device Co., Ltd.
General Hospital · 174d
Cleared Feb 19, 2015
Vienna System
K142597 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 157d
Cleared Feb 19, 2015
StaXx(R) XD System
K142996 · MQP
Spine Wave, Inc.
Orthopedic · 126d