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
28729–28752 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 2017
MindMotionPRO
K162748 · LXJ
Mindmaze SA
Physical Medicine · 206d
Cleared Apr 24, 2017
ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension
K163650 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 122d
Cleared Apr 24, 2017
Foot and Hand Motion
K170012 · HWC
Newclip Technics
Orthopedic · 111d
Cleared Apr 24, 2017
ECG Disposable Lead Wire
K170536 · DSA
APK Technology Co., Ltd.
Cardiovascular · 60d
Cleared Apr 24, 2017
FDR AQRO (DR-XD 1000)
K170858 · IZL
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 33d
Cleared Apr 24, 2017
EVOS Small Fragment Plating System
K170887 · HRS
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Apr 21, 2017
VivaChek Ino Blood Glucose Monitoring System
K160179 · NBW
Vivachek Laboratories, Inc.
Chemistry · 450d
Cleared Apr 21, 2017
Steri-Cassette and Steri-Cage Sterilization Packaging System
K162063 · KCT
Sybron Dental Specialties
General Hospital · 269d
Cleared Apr 21, 2017
Randox RX Daytona Plus Alkaline Phosphatase (ALP)
K162275 · CJE
Randox Laboratories Limited
Chemistry · 252d
Cleared Apr 21, 2017
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED...
K162294 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 249d
Cleared Apr 21, 2017
StealthConnect Remote Viewing, Planning and Collaboration System
K162655 · HAW
Medtronic Navigation, Inc.
Neurology · 210d
Cleared Apr 21, 2017
Aero Chrome* Select Breathable Performance Surgical Gowns
K162930 · FYA
Halyard Health, Inc.
General Hospital · 184d
Cleared Apr 21, 2017
TSIII BA Fixture
K163088 · DZE
Osstem Implant Co., Ltd.
Dental · 168d
Cleared Apr 21, 2017
CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless...
K163255 · DXN
Caretaker Medical, LLC
Cardiovascular · 151d
Cleared Apr 21, 2017
Braun No Touch + Forehead NTF3000 Thermometer
K163516 · FLL
Kaz USA, Inc., A Helen of Troy Company
General Hospital · 127d
Cleared Apr 21, 2017
Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga
K163537 · EOQ
Covidien, LLC
Ear, Nose, Throat · 126d
Cleared Apr 21, 2017
DERMABOND PRINEO Skin Closure System
K163645 · OMD
Ethicon, LLC
General & Plastic Surgery · 119d
Cleared Apr 21, 2017
syngo.CT Cardiac Planning
K170221 · JAK
Siemens Healthcare GmbH
Radiology · 86d
Cleared Apr 21, 2017
joimax Endovapor 2
K170358 · GEI
Joimax GmbH
General & Plastic Surgery · 74d
Cleared Apr 21, 2017
Nexxis OR, Nexxis
K170537 · DXJ
Barco N.V.
Cardiovascular · 57d
Cleared Apr 21, 2017
PercuNav Image Fusion and Interventional Navigation
K170716 · JAK
Philips Ultrasound, Inc.
Radiology · 43d
Cleared Apr 21, 2017
Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil
K170721 · GEI
Precision Surgical, LLC
General & Plastic Surgery · 43d
Cleared Apr 21, 2017
EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci...
K170865 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 29d
Cleared Apr 21, 2017
LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated
K170869 · GEI
Covidien
General & Plastic Surgery · 29d