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
29329–29352 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 21, 2017
Tomcat Cervical Spinal System
K170953 · OVE
Choicespine, LP
Orthopedic · 21d
Cleared Apr 20, 2017
K3
K152830 · EIA
Osstem Implant Co., Ltd.
Dental · 569d
Cleared Apr 20, 2017
Cardinal Health Sterilization Wrap
K161910 · FRG
Cardinal Health200, LLC
General Hospital · 282d
Cleared Apr 20, 2017
Ross Ru Wound Dressing Gel
K162017 · FRO
Biotd S.A.
General & Plastic Surgery · 273d
Cleared Apr 20, 2017
PENTAX Medical ENT Video Imaging System
K162151 · EOB
Pentax of America, Inc.
Ear, Nose, Throat · 261d
Cleared Apr 20, 2017
Ax Stand-Alone ALIF System
K162236 · OVD
Innovasis, Inc.
Orthopedic · 254d
Cleared Apr 20, 2017
Sniper Staple System
K162354 · JDR
Trilliant Surgical, Ltd.
Orthopedic · 240d
Cleared Apr 20, 2017
BeneVision Central Monitoring System
K162607 · MSX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 213d
Cleared Apr 20, 2017
HyperSense
K162722 · LNH
Ge Medical Systems, LLC
Radiology · 203d
Cleared CT Apr 20, 2017
Penumbra 3D Revascularization Device
K162901 · NRY
Penumbra, Inc.
Neurology · 185d