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
25225–25248 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 08, 2018
Alere BinaxNOW Influenza A & B Card 2, Alere Reader
K181853 · PSZ
Alere Scarborough, Inc.
Microbiology · 28d
Cleared Aug 08, 2018
Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in...
K181946 · JWY
Thermo Fisher Scientific
Microbiology · 19d
Cleared Aug 07, 2018
Model WP-3840 and WP-3040
K173848 · IYE
Cnmc Co., Inc.
Radiology · 231d
Cleared Aug 07, 2018
VascuEase IC-1200-WH
K180248 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 190d
Cleared Aug 07, 2018
EndoWrist Mercury Bipolar Grasper
K180351 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 180d
Cleared Aug 07, 2018
Surgical Silver Post Operative Dressing
K180634 · FRO
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 148d
Cleared Aug 07, 2018
AlignRT Plus
K181218 · IYE
Vision Rt, Ltd.
Radiology · 92d
Cleared Aug 07, 2018
Self-adhesive Electrode
K181234 · GXY
Dong Guan OU Kang Electronics Co., Ltd.
Neurology · 90d
Cleared Aug 07, 2018
Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard...
K181828 · MOF
Scientia Vascular, LLC
Neurology · 29d
Cleared Aug 07, 2018
CubeVue
K181962 · LLZ
Curvebeam, LLC
Radiology · 15d
Cleared Aug 06, 2018
Arthrex SwiveLock
K173845 · MBI
Arthrex, Inc.
Orthopedic · 230d
Cleared Aug 06, 2018
MINUET LCD, MINUET LCD eco
K180075 · HGX
Unimom.Co
Obstetrics & Gynecology · 208d
Cleared Aug 06, 2018
EP Granules™ BVF
K180853 · MQV
Elute, Inc.
Orthopedic · 126d
Cleared Aug 06, 2018
CystoSure Plus Catheter
K181346 · EZL
Emmy Medical, LLC
Gastroenterology & Urology · 77d
Cleared Aug 05, 2018
VesoFlow Lite DVT Compression Device
K181217 · JOW
Caremed Supply, Inc.
Cardiovascular · 90d
Cleared Aug 05, 2018
APTUS® Proximal Humerus System
K181425 · HRS
Medartis AG
Orthopedic · 66d
Cleared Aug 03, 2018
EasyTouch Safety Pen Needle
K163578 · FMI
Mhc Medical Products, LLC
General Hospital · 591d
Cleared Aug 03, 2018
VirtuOst Vertebral Fracture Assessment
K171435 · LLZ
O.N. Diagnostics, LLC
Radiology · 445d
Cleared Aug 03, 2018
BH Sterilization Pouch
K172280 · FRG
Bh Medical Products Co., Ltd.
General Hospital · 371d
Cleared Aug 03, 2018
ECG recorder and Arrhythmia Detector
K173461 · DSH
Smart Solutions Technologies SL
Cardiovascular · 269d
Cleared Aug 03, 2018
Arm Type Blood Pressure Monitor
K180155 · DXN
Avita Corporation
Cardiovascular · 196d
Cleared Aug 03, 2018
FUJIFILM 600 Series Endoscope EG-600WR v2
K180341 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 177d
Cleared Aug 03, 2018
K2M Expandable Interbody System
K180777 · MAX
K2m, Inc.
Orthopedic · 130d
Cleared Aug 03, 2018
Fluent Fluid Management System
K180825 · HIG
Hologic, Inc.
Obstetrics & Gynecology · 126d