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
25201–25224 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 10, 2018
Portable X-ray System (Model: MiniX-V, Mini X-S)
K181891 · EHD
Digimed Co., Ltd.
Radiology · 28d
Cleared Aug 09, 2018
Presygen/si-1
K171245 · MUD
Christie Medical Holdings, Inc.
Cardiovascular · 468d
Cleared Aug 09, 2018
VT - 100, VT - 200
K173407 · OMP
Carilex Medical, Inc.
General & Plastic Surgery · 281d
Cleared Aug 09, 2018
FORA GTel Blood Glucose Monitoring System
K173505 · NBW
Foracare, Inc.
Chemistry · 269d
Cleared Aug 09, 2018
MyPlant II Implant System
K173819 · DZE
Hager& Meisinger GmbH
Dental · 234d
Cleared Aug 09, 2018
Titan Ag 200
K173844 · FRO
Specialty Fibres and Materials, Ltd.
General & Plastic Surgery · 233d
Cleared Aug 09, 2018
Self-destruction Safety Syringes for Single Use
K180417 · MEG
Berpu Medical Technology Co., Ltd.
General Hospital · 175d
Cleared Aug 09, 2018
SECULOK™ Suture Anchor
K180759 · MBI
U&I Corporation
Orthopedic · 140d
Cleared Aug 09, 2018
LENSAR Laser System - fs 3D (LLS-fs 3D)
K181430 · OOE
Lensar, Inc.
Ophthalmic · 69d
Cleared Aug 09, 2018
EVOS Wrist Fracture Plating System
K181533 · HRS
Smith & Nephew, Inc.
Orthopedic · 59d
Cleared Aug 09, 2018
Anchor Bolt (as an accessory to Depth Electrodes)
K181544 · GZL
Ad-Tech Medical Instrument Corporation
Neurology · 58d
Cleared Aug 09, 2018
INFINITY Total Ankle System
K181557 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 57d
Cleared Aug 09, 2018
Kodiak Spinal Fixation System
K181677 · NKB
Alphatec Spine, Inc.
Orthopedic · 44d
Cleared Aug 09, 2018
ICONN Answer II Suture Anchor
K181680 · MBI
Iconn Orthopedics, LLC
Orthopedic · 44d
Cleared Aug 09, 2018
MotoCLIP/HiMAX Step Staple Implant System
K181866 · JDR
Crossroads Extremity Systems, LLC
Orthopedic · 28d
Cleared Aug 08, 2018
Ageless Health Medical Digital Thermometer
K172508 · FLL
Ageless Health Industrial Co., Ltd.
General Hospital · 352d
Cleared CT Aug 08, 2018
F&P SleepStyle
K173193 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 310d
Cleared Aug 08, 2018
EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay...
K180169 · DQY
Imperative Care, Inc.
Neurology · 198d
Cleared Aug 08, 2018
Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical...
K180221 · KGO
Smart Glove Corporation Sdn. Bhd.
General Hospital · 195d
Cleared Aug 08, 2018
UNIQA Dental Implants System
K180598 · DZE
Uniqa Dental, Ltd.
Dental · 154d
Cleared Aug 08, 2018
SmartLinx Vitals Plus Patient Monitoring System
K180734 · MWI
Capsule Technologie
Cardiovascular · 141d
Cleared Aug 08, 2018
Pure EP
K180805 · DQK
Biosig Technologies
Cardiovascular · 133d
Cleared Aug 08, 2018
7D Surgical System Cranial Application
K181041 · HAW
7D Surgical, Inc.
Neurology · 111d
Cleared Aug 08, 2018
4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F &...
K181836 · DQO
Cordis, A Cardinal Health Company
Cardiovascular · 29d