FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
27961–27984 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 2017
Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)
K171161 · MQV
Dimensional Bioceramics, LLC
Orthopedic · 158d
Cleared Sep 25, 2017
Exofin Fusion Skin Closure System
K171442 · OMD
Chemence Medical, Inc.
General & Plastic Surgery · 132d
Cleared Sep 25, 2017
LapBag
K171726 · GCJ
Sejong Medical Co., Ltd.
General & Plastic Surgery · 105d
Cleared Sep 25, 2017
GALAXY G3 Mini Microcoil Delivery System
K171862 · HCG
Codman & Shurtleff, Inc.
Neurology · 95d
Cleared Sep 25, 2017
Electrocardiograph
K171943 · DPS
Edan Instruments, Inc.
Cardiovascular · 89d
Cleared Sep 25, 2017
Xpert Xpress Strep A
K172126 · PGX
Cepheid
Microbiology · 73d
Cleared Sep 25, 2017
PRECICE System
K172628 · HSB
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 24d
Cleared Sep 24, 2017
Powder-free Clear Vinyl Patient Examination Gloves
K171460 · LYZ
Shandong Zhiwei Medical Products, Co....
General Hospital · 129d
Cleared Sep 22, 2017
Straumann CARES Golden Ti/TiN Abutments
K162848 · NHA
Institut Straumann AG
Dental · 346d
Cleared Sep 22, 2017
NOWCARDIO SYSTEM
K162956 · QYX
Contex International Technologies...
Cardiovascular · 333d
Cleared Sep 22, 2017
Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera,...
K163674 · NUC
Neo Cosmetique
Obstetrics & Gynecology · 269d
Cleared Sep 22, 2017
Thermage FLX System and Accessories
K170758 · GEI
Solta Medical
General & Plastic Surgery · 193d
Cleared Sep 22, 2017
SYSTEM 1E Liquid Chemical Sterilant Processing System
K170956 · MED
STERIS Corporation
General Hospital · 175d
Cleared Sep 22, 2017
TempSure
K171262 · GEI
Cynosure, Inc.
General & Plastic Surgery · 144d
Cleared Sep 22, 2017
Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing...
K171303 · KPS
University of Texas Medical School AT...
Radiology · 142d
Cleared Sep 22, 2017
Occlusion Detection Dressing Kit
K171499 · OMP
Cardinalhealth
General & Plastic Surgery · 122d
Cleared Sep 22, 2017
WiTouch Pro, WiTouch, Neubac
K171599 · NUH
Hollywog, LLC
Neurology · 113d
Cleared Sep 22, 2017
Sterling Supreme Diode Laser
K171986 · GEX
CAO Group, Inc.
General & Plastic Surgery · 81d
Cleared Sep 22, 2017
Matira™ Anterior Cervical System
K172086 · KWQ
Kalitec Direct, LLC
Orthopedic · 73d
Cleared Sep 22, 2017
IV Fat Emulsion Administration Sets
K172544 · FPA
Baxter Healthcare Corporation
General Hospital · 30d
Cleared Sep 22, 2017
SERI Contour
K172545 · OXF
Sofregen Medical, Inc.
General & Plastic Surgery · 30d
Cleared Sep 22, 2017
ULTRASCORE Focused Force PTA Balloon
K172571 · PNO
C. R. Bard
Cardiovascular · 25d
Cleared Sep 21, 2017
Salter Labs Bubble Humidifier
K161719 · BTT
Salter Labs
Anesthesiology · 456d
Cleared Sep 21, 2017
AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX
K163462 · JHX
Radiometer Medical Aps
Chemistry · 286d