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
35161–35184 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 2015
Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System
K143528 · NHA
Zimmer Dental, Inc.
Dental · 140d
Cleared May 01, 2015
Stryker MIS Attachments and Cutting Accessories
K143540 · HBE
Stryker Corporation
Neurology · 137d
Cleared May 01, 2015
Nuance FLOW
K143679 · EBF
Den-Mat Holdings, LLC
Dental · 128d
Cleared May 01, 2015
V10 system
K150035 · PBX
Viora , Ltd.
General & Plastic Surgery · 112d
Cleared CT May 01, 2015
Invictus Medical GelShield
K150243 · FMP
Invictus Medical, Inc.
General Hospital · 88d
Cleared May 01, 2015
ADVIA Centaur TSH3-Ultra
K150403 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 72d
Cleared May 01, 2015
G7 Dual Mobility System
K150522 · LPH
Biomet, Inc.
Orthopedic · 60d
Cleared May 01, 2015
Terumo Pump Tubing
K150542 · DWE
Terumo Cardiovascular Systems...
Cardiovascular · 59d
Cleared May 01, 2015
Vaginal Moisturizing Gel
K150615 · NUC
Combe Incorporated
Obstetrics & Gynecology · 52d
Cleared May 01, 2015
Rush Medullary Pins
K150626 · HTY
Zimmer, Inc.
Orthopedic · 51d
Cleared May 01, 2015
Digital Dental Intra Oral Sensor, EzSensor Smart
K150797 · MUH
Rayence Co., Ltd.
Radiology · 36d
Cleared May 01, 2015
Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System,...
K150818 · KTT
Zimmer, Inc.
Orthopedic · 35d
Cleared May 01, 2015
Tablo Console with Wireless Capability
K150880 · KDI
Outset Medical
Gastroenterology & Urology · 30d
Cleared May 01, 2015
BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System
K150891 · FCG
Covidien, LLC( Formerly Beacon...
General & Plastic Surgery · 29d
Cleared May 01, 2015
Elecsys Progesterone III Cal Check 5
K150955 · JJX
Roche Diagnostics
Chemistry · 22d
Cleared Apr 30, 2015
XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and
K142646 · OMP
Genadyne Biotechnologies, Inc.
General & Plastic Surgery · 225d
Cleared Apr 30, 2015
BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily...
K142820 · LPL
Abb Optical Group, LLC
Ophthalmic · 212d
Cleared Apr 30, 2015
VALIDATE Anemia Calibration Verification/ Linearity Test Kit
K142964 · JJY
Maine Standards Company, LLC
Chemistry · 198d
Cleared Apr 30, 2015
ApneaLink Air
K143272 · MNR
Resmed Germany, Inc.
Anesthesiology · 167d
Cleared Apr 30, 2015
SILVERLON BURN CONTACT DRESSINGS
K150256 · FRO
Argentum Medical
General & Plastic Surgery · 86d
Cleared Apr 30, 2015
Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)
K150330 · JIR
ACON Laboratories, Inc.
Chemistry · 79d
Cleared Apr 30, 2015
ViSi Mobile Monitoring System
K150361 · MWI
Sotera Wireless, Inc.
Cardiovascular · 77d
Cleared Apr 30, 2015
NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
K150385 · LPL
Visioneering Technologies, Inc.
Ophthalmic · 71d
Cleared Apr 30, 2015
G3 Active Plate Large Fragment System
K150649 · HRS
Genesis Fracture Care, Inc.
Orthopedic · 49d