FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
21553–21576 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 2019
Venus Legacy Pro Device
K191528 · GEI
Venus Concept USA, Inc.
General & Plastic Surgery · 88d
Cleared Sep 06, 2019
Sure-Fine Insulin Syringes
K191531 · FMF
Shina Med Corporation
General Hospital · 88d
Cleared Sep 06, 2019
Willow Wearable Breast Pump 2.0
K191577 · HGX
Exploramed Nc7, Inc.
Obstetrics & Gynecology · 84d
Cleared Sep 06, 2019
TTC Phantom Intramedullary Nail System
K191782 · HSB
Paragon 28, Inc.
Orthopedic · 66d
Cleared Sep 06, 2019
Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive...
K191845 · PGY
Barco N.V.
Radiology · 58d
Cleared Sep 06, 2019
EVO Platform
K192160 · GEX
Quanta System Spa
General & Plastic Surgery · 28d
Cleared Sep 06, 2019
Aquilion ONE (TSX-306A/3) V10.0
K192188 · JAK
Canon Medical Systems Corporation
Radiology · 24d
Cleared Sep 06, 2019
Lumify Diagnostic Ultrasound System
K192226 · IYN
Philips Health Care
Radiology · 21d
Cleared Sep 05, 2019
EVIS EXERA III Bronchovideoscope Olympus BF-XT190
K183419 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 269d
Cleared Sep 05, 2019
FUJIFILM Ultrasonic Endoscope
K183433 · ODG
Fujifilm Corporation
Gastroenterology & Urology · 268d
Cleared Sep 05, 2019
Holinwon 30
K183563 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 259d
Cleared Sep 05, 2019
GM501 Wash
K190383 · MQL
Hamilton Thorne, Inc.
Obstetrics & Gynecology · 198d
Cleared Sep 05, 2019
bili-hut
K190899 · LBI
Little Sparrows Technologies, Inc.
General Hospital · 150d
Cleared Sep 05, 2019
SmarTemp X1
K190930 · EBG
Parkell, Inc.
Dental · 148d
Cleared Sep 05, 2019
Advocate Non-Contact Infrared Thermometer
K191004 · FLL
Broadmaster Biotech, Corp.
General Hospital · 142d
Cleared Sep 05, 2019
SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900
K191343 · MED
STERIS Corporation
General Hospital · 108d
Cleared Sep 05, 2019
Persona Revision Knee System
K191625 · JWH
Zimmer, Inc.
Orthopedic · 79d
Cleared Sep 05, 2019
FlowTriever Retrieval/Aspiration System
K191710 · QEW
Inari Medical
Cardiovascular · 71d
Cleared Sep 05, 2019
Dual-Safety Pen Needle
K191853 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 57d
Cleared Sep 05, 2019
Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator...
K192020 · JOJ
STERIS Corporation
General Hospital · 38d
Cleared Sep 05, 2019
3M Clarity Aligners
K192119 · NXC
3M Company
Dental · 30d
Cleared Sep 05, 2019
HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip,...
K192123 · LCX
Qingdao Hightop Biotech Co., Ltd.
Chemistry · 30d
Cleared Sep 05, 2019
Freedom Primary PCK
K192148 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 28d
Cleared Sep 04, 2019
K3
K183347 · EIA
Osstem Implant Co., Ltd.
Dental · 275d