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
18793–18816 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 28, 2020
NP1 Instrument, Creo Electrosurgical System
K200003 · NEY
Creo Medical, Ltd.
General & Plastic Surgery · 300d
Cleared Oct 28, 2020
Thermoforming Sheet Materials
K200125 · MQC
Erkodent Erich Kopp GmbH
Dental · 281d
Cleared Oct 28, 2020
Bright Bond Universal
K200153 · KLE
Genoss Co., Ltd.
Dental · 280d
Cleared Oct 28, 2020
NIM Vital, Nerve Integrity Monitor
K200759 · GWF
Medtronic Xomed, Inc.
Neurology · 218d
Cleared Oct 28, 2020
LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System
K200790 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 216d
Cleared Oct 28, 2020
Sterile High-pressure Angiographic Syringes for single-use
K201395 · DXT
Youwo (Guangzhou) Medical Device Co.,...
General Hospital · 154d
Cleared CT Oct 28, 2020
Ultimate Contour, Ultimate Contour Mini
K201475 · PBX
CAO Group, Inc.
General & Plastic Surgery · 147d
Cleared Oct 28, 2020
EVOS Cabling System
K201497 · JDQ
Pioneer Surgical Technology, Inc....
Orthopedic · 145d
Cleared Oct 28, 2020
LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality...
K202089 · POV
Bonraybio Co., Ltd.
Hematology · 92d
Cleared Oct 28, 2020
Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ...
K202259 · MBI
Parcus Medical, LLC
Orthopedic · 79d
Cleared Oct 28, 2020
Tri-Staple 2.0 Reloads
K202864 · GDW
Covidien
General & Plastic Surgery · 30d
Cleared Oct 28, 2020
Syntec Femoral Nail Extended System
K202935 · HSB
Syntec Scientific Corporation
Orthopedic · 29d
Cleared Oct 27, 2020
TIB Abutment System
K193084 · NHA
Southern Implants (Pty), Ltd.
Dental · 357d
Cleared Oct 27, 2020
Bright Low Flow
K200156 · EBF
Genoss Co., Ltd.
Dental · 279d
Cleared Oct 27, 2020
FREEPRINT temp
K200273 · EBG
Detax GmbH & Co. KG
Dental · 266d
Cleared Oct 27, 2020
Dental Computed Tomography X-Ray System, Green X
K201627 · OAS
VATECH Co., Ltd.
Radiology · 133d
Cleared Oct 27, 2020
NextAR TKA Platform
K202152 · SBF
Medacta International S.A.
Orthopedic · 85d
Cleared Oct 27, 2020
OrthoNext Platform System
K202519 · LLZ
Orthofix Srl
Radiology · 56d
Cleared Oct 27, 2020
IlluminOss Bone Stabilization System
K202887 · QAD
Illuminoss Medical, Inc.
Orthopedic · 29d
Cleared Oct 27, 2020
General Cutting Contra Handpiece
K202960 · EGS
Nakanishi, Inc.
Dental · 27d
Cleared Oct 27, 2020
Mazor X
K203005 · OLO
Mazor Robotics , Ltd.
Orthopedic · 26d
Cleared Oct 27, 2020
Triathlon PKR System
K203099 · HSX
Howmedica Osteonics Corp. A.K.A....
Orthopedic · 13d
Cleared Oct 26, 2020
Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use...
K200150 · LZA
Medline Industries, Inc.
General Hospital · 278d
Cleared Oct 26, 2020
ACURA Stabilization System
K200937 · NKB
Indius Medical Technologies Pvt. , Ltd.
Orthopedic · 201d