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
21889–21912 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 08, 2019
Attune Revision LPS Inserts
K191779 · KRO
Depuy(Ireland)
Orthopedic · 98d
Cleared Oct 08, 2019
Premia Spine XL Instruments
K191854 · OLO
Premia Spine, Ltd.
Orthopedic · 90d
Cleared Oct 08, 2019
32mm Glenosphere and Humeral Cup
K192206 · PHX
Fx Shoulder USA, Inc.
Orthopedic · 55d
Cleared Oct 07, 2019
Cepheid Xpert Respiratory Control Panel
K190086 · PMN
Microbiologics, Inc.
Microbiology · 263d
Cleared Oct 07, 2019
NIO-I
K190538 · FMI
Waismed, Ltd.
General Hospital · 217d
Cleared Oct 07, 2019
Interlude Rolled Tampons in Plastic Applicator
K191431 · HEB
Albaad Fem
Obstetrics & Gynecology · 131d
Cleared Oct 07, 2019
PROFEMUR TL2 Stems
K191632 · LZO
Microport Orthopedics, Inc.
Orthopedic · 110d
Cleared Oct 07, 2019
Dexcom G6 Pro Continuous Glucose Monitoring System
K191833 · QII
Dexcom, Inc.
Chemistry · 90d
Cleared Oct 05, 2019
AFX Femoral Implant with Inserter
K192428 · MBI
Cayenne Medical
Orthopedic · 30d
Cleared Oct 04, 2019
Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile,...
K183441 · LZA
Semperit Investments Asia Pte , Ltd.
General Hospital · 296d
Cleared Oct 04, 2019
Vivio System
K183710 · DQD
Avicena, LLC
Cardiovascular · 277d
Cleared Oct 04, 2019
Urethrotech UCD
K190060 · EZL
Urethrotech
Gastroenterology & Urology · 266d
Cleared Oct 04, 2019
Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe
K190183 · MEG
Anhui Hongyu Wuzhou Medical...
General Hospital · 245d
Cleared Oct 04, 2019
DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate,...
K190298 · CDD
Beckman Coulter Biomedical GmbH
Chemistry · 235d
Cleared Oct 04, 2019
Safergel Sterile Ultrasound Gel
K190591 · MUI
Safersonic Us, Inc.
Radiology · 211d
Cleared Oct 04, 2019
Tokuyama Rebase III
K190940 · EBI
Tokuyama Dental Corporation
Dental · 177d
Cleared Oct 04, 2019
CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S /...
K191713 · JAA
Omega Medical Imaging, LLC
Radiology · 100d
Cleared Oct 04, 2019
Ceramill A-Temp
K191843 · EBG
Amann Girrbach AG
Dental · 87d
Cleared Oct 04, 2019
ProFound AI Software V2.1
K191994 · QDQ
Icad, Inc.
Radiology · 70d
Cleared Oct 04, 2019
Bausch + Lomb PreVue Inserter for enVista Preloaded
K192005 · MSS
Bausch & Lomb, Inc.
Ophthalmic · 67d
Cleared Oct 04, 2019
Sutter Arrowtip Monopolar Electrodes
K192128 · GEI
Sutter Medizintechnik GmbH
General & Plastic Surgery · 58d
Cleared Oct 04, 2019
Steerable Introducer 12F
K192422 · DRA
Freudenberg Medical, LLC
Cardiovascular · 30d
Cleared Oct 04, 2019
LZI Methadone II Enzyme Immunoassay
K192433 · DJR
Lin-Zhi International, Inc.
Toxicology · 29d
Cleared Oct 04, 2019
Delta Xtend Revers Shoulder System
K192448 · PHX
Depuy(Ireland)
Orthopedic · 28d