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
27049–27072 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 05, 2018
ToggleLoc System
K173278 · MBI
Biomet, Inc.
Orthopedic · 84d
Cleared Jan 05, 2018
ViewPoint 6
K173456 · LLZ
Ge Medical Systems Ultrasound and...
Radiology · 59d
Cleared Jan 05, 2018
AquaShield System CO2- Fujifilm
K173650 · FEQ
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 38d
Cleared Jan 04, 2018
WAVE Clinical Platform
K171056 · MWI
Excel Medical Electronics, LLC
Cardiovascular · 269d
Cleared Jan 04, 2018
LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope...
K171113 · HIH
Lina Medical Aps
Obstetrics & Gynecology · 265d
Cleared Jan 04, 2018
OmniCap
K171235 · CCK
Respirion, Inc.
Anesthesiology · 252d
Cleared Jan 04, 2018
Alians Elbow Locking Plating System
K171372 · HRS
Newclip Technics
Orthopedic · 239d
Cleared Jan 04, 2018
ePatch
K171410 · DSH
Braemar Manufacturing, LLC
Cardiovascular · 234d
Cleared Jan 04, 2018
Attain Assist CS Access Catheter
K171819 · DQY
Creganna Medical Also Doing Business...
Cardiovascular · 199d
Cleared Jan 04, 2018
EarlySense Bed Sensing Unit
K171836 · BZQ
Earlysense, Ltd.
Anesthesiology · 198d
Cleared Jan 04, 2018
Bone Screws 6.5mm
K172456 · LPH
Lima Corporate S.P.A.
Orthopedic · 143d
Cleared Jan 04, 2018
BIO-C SEALER
K172701 · KIF
Angelus Industria DE Produtos...
Dental · 119d
Cleared Jan 04, 2018
Tec 820, Tec 850
K172702 · CAD
Datex-Ohmeda, Inc.
Anesthesiology · 119d
Cleared Jan 03, 2018
AirFit F20
K170924 · BZD
Resmed, Ltd.
Anesthesiology · 280d
Cleared Jan 03, 2018
Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate,...
K172502 · PHX
Biomet Manufacturing Corp
Orthopedic · 138d
Cleared Jan 03, 2018
Straumann CARES Abutments CoCr
K172798 · NHA
Institut Straumann AG
Dental · 107d
Cleared Jan 03, 2018
Facet Screw Fixation System
K173198 · MRW
U&I Corporation
Orthopedic · 93d
Cleared Jan 03, 2018
Juliet Ti LL
K173702 · MAX
Spineart
Orthopedic · 30d
Cleared Jan 02, 2018
Clover 50/Clover60/Clover70 Diagnostic Ultrasound System
K163712 · IYN
Shenzhen Wisonic Medical Technology...
Radiology · 368d
Cleared Jan 02, 2018
Snorer's Friend
K171529 · LRK
Scope Healthcare Technologies Pty, Ltd.
Dental · 222d
Cleared Jan 02, 2018
Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound...
K172860 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 104d
Cleared Dec 29, 2017
Osteo-P Bone Graft Substitute
K170165 · MQV
Molecular Matrix, Inc.
Orthopedic · 344d
Cleared Dec 29, 2017
AUTOBAHN Nailing System
K171108 · HSB
Globus Medical, Inc.
Orthopedic · 259d
Cleared Dec 29, 2017
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
K171573 · FDX
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 213d