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
34825–34848 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 2015
Digital Automatic Wrist Blood Pressure Monitor MD2400
K143733 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 94d
Cleared Apr 03, 2015
Arthrex Distal Radius System
K143749 · HRS
Arthrex, Inc.
Orthopedic · 93d
Cleared Apr 03, 2015
CYMA
K150027 · GEX
Whitecap Technologies, LLC
General & Plastic Surgery · 86d
Cleared Apr 03, 2015
2MP Color LCD Monitor, RadiForce RS240
K150106 · PGY
Eizo Corporation
Radiology · 73d
Cleared Apr 03, 2015
Monobond Etch & Prime
K150164 · KLE
Ivoclar Vivadent, AG
Dental · 67d
Cleared Apr 03, 2015
InFill Interbody Fusion Devices
K150206 · MAX
Pinnacle Spine Group, LLC
Orthopedic · 64d
Cleared Apr 03, 2015
Crux Vena Cava Filter System, femoral
K150262 · DTK
Volcano Corporation
Cardiovascular · 58d
Cleared Apr 03, 2015
V8 Transluminal BAV Catheter
K150343 · OZT
Intervalve, Inc.
Cardiovascular · 51d
Cleared Apr 03, 2015
Santis Pedicle Screw System
K150507 · NKB
Lanterna Medical Technologies
Orthopedic · 36d
Cleared Apr 02, 2015
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX
K141227 · JXG
Sophysa SA
Neurology · 325d
Cleared Apr 02, 2015
AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM
K141687 · JXG
Aesculap, Inc.
Neurology · 294d
Cleared Apr 02, 2015
MYGAIT STIMULATION SYSTEM
K141812 · GZI
Otto Bock Healthcare Products GmbH
Neurology · 269d
Cleared Apr 02, 2015
FLASHPAK STERILIZATION CONTAINER SYSTEM
K141826 · FRG
Symmetry Medical Inc- Manchester
General Hospital · 269d
Cleared Apr 02, 2015
PHYSICA KR KNEE SYSTEM
K141934 · JWH
Lima Corporate S.P.A.
Orthopedic · 259d
Cleared Apr 02, 2015
BRIGHTMATTER NAVIGATION SYSTEM
K142024 · HAW
Synaptive Medical, Inc.
Neurology · 251d
Cleared Apr 02, 2015
Reliance Interspinous Plate System
K142217 · PEK
Reliance Medical Systems, LLC
Orthopedic · 233d
Cleared Apr 02, 2015
Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors
K143018 · PIF
Covidien
Gastroenterology & Urology · 164d
Cleared Apr 02, 2015
Tanning Lamp
K143043 · LEJ
Unilam Co., Ltd.
General & Plastic Surgery · 162d
Cleared Apr 02, 2015
IS4000 8mm Harmonic ACE Curved Shears
K143132 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 153d
Cleared Apr 02, 2015
Hahn Tapered Implant System
K143353 · DZE
Prismatik Dentalcraft, Inc.
Dental · 129d
Cleared Apr 02, 2015
AWARE
K143372 · MWI
Ambient Clinical Analytics
Cardiovascular · 128d
Cleared Apr 02, 2015
Euphora Rapid Exchange Balloon Dilatation Catheter
K143480 · LOX
Medtronic, Inc.
Cardiovascular · 115d
Cleared Apr 02, 2015
Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port
K150010 · PIO
Cedic S.R.L.
Gastroenterology & Urology · 90d
Cleared Apr 02, 2015
J2A Dental Implant System, J2C Dental Implant System
K150060 · DZE
Kj Meditech Co., Ltd.
Dental · 79d