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
31081–31104 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 2016
Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure...
K161887 · DQX
Volcano Corporation
Cardiovascular · 71d
Cleared Sep 20, 2016
SomnoDent ALPHA
K162306 · LRK
Somnomed, Inc.
Dental · 34d
Cleared Sep 19, 2016
AirStrip RPM
K160862 · MSX
Airstrip Technologies, Inc.
Cardiovascular · 174d
Cleared Sep 19, 2016
Super Distal Access (SDA)
K161262 · DQY
Inneuroco, Inc.
Cardiovascular · 137d
Cleared Sep 19, 2016
PixelShine
K161625 · LLZ
Algomedica
Radiology · 98d
Cleared Sep 19, 2016
5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR
K162497 · PGY
Eizo Corporation
Radiology · 12d
Cleared Sep 18, 2016
Guidewire 0.6 Single Use
K161940 · PGW
Fiagon GmbH
Ear, Nose, Throat · 66d
Cleared Sep 17, 2016
KARL STORZ Flexible Video-Neuro-Endoscope System
K161112 · GWG
KARL STORZ Endoscopy-America, Inc.
Neurology · 150d
Cleared Sep 16, 2016
Sentry WEB SmartInterp
K153654 · DQK
Carefusion Germany 234 GmbH
Cardiovascular · 270d
Cleared Sep 16, 2016
VORTRAN Manometer
K153733 · CAP
Vortran Medical Technology 1, Inc.
Anesthesiology · 263d
Cleared Sep 16, 2016
n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,
K160262 · EIH
Institut Straumann AG
Dental · 227d
Cleared Sep 16, 2016
NutraStim Hair Laser Helmet
K160728 · OAP
Nutra Luxe MD, LLC
General & Plastic Surgery · 184d
Cleared Sep 16, 2016
CATSmart
K160735 · CAC
Fresenius Kabi AG
Anesthesiology · 183d
Cleared Sep 16, 2016
Neodent Implant System - Titanium Base for CEREC
K160964 · NHA
Jjgc Industria E Comercio DE...
Dental · 163d
Cleared Sep 16, 2016
Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse...
K161162 · GEX
Ellipse A/S
General & Plastic Surgery · 144d
Cleared Sep 16, 2016
Syntorr K-wire and Pin System
K161489 · HTY
Syntorr, Inc.
Orthopedic · 107d
Cleared Sep 16, 2016
Bone Solutions Mixing and Delivery System
K161568 · FMF
Bone Solutions, Inc.
General Hospital · 101d
Cleared Sep 16, 2016
LigaSure Retractable L-Hook Laparoscopic Sealer/Divider
K161804 · GEI
Covidien
General & Plastic Surgery · 78d
Cleared Sep 16, 2016
DoseCHECK
K161946 · IYE
Sun Nuclear Corporation
Radiology · 63d
Cleared Sep 16, 2016
JiveX
K162008 · LLZ
Visus Technology Transfer GmbH
Radiology · 58d
Cleared Sep 16, 2016
TRILLIUM Oval Head Coil 32
K162079 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 51d
Cleared Sep 16, 2016
mi-eye 2, mi-eye 2 monitor
K162475 · HRX
Trice Medical
Orthopedic · 10d
Cleared Sep 15, 2016
KBL Sunlamp Products (= Device Bundling name)
K151962 · LEJ
Kbl AG
General & Plastic Surgery · 427d
Cleared Sep 15, 2016
Luminesse Shaded Zirconia SZ
K152023 · EIH
Talladium, Inc.
Dental · 422d