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
29185–29208 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 2017
On1 Concept
K161655 · NHA
Nobel Biocare AB
Dental · 257d
Cleared Feb 28, 2017
Surface Applicator Set
K162018 · JAQ
Varian Medical Systems, Inc.
Radiology · 229d
Cleared Feb 28, 2017
RTC 26-C Inline Aerosol Adapter
K162753 · CAF
Instrumentation Industries, Inc.
Anesthesiology · 151d
Cleared Feb 28, 2017
Smart Laser Indirect Ophthalmoscope (LIO)
K162837 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 140d
Cleared Feb 28, 2017
CareLink SmartSync Device Manager - Pacing System Analyzer
K163008 · DTA
Medtronic, Inc.
Cardiovascular · 123d
Cleared Feb 28, 2017
EPIC Extremity Snap-Off Screw
K163038 · HWC
Epic Extremity, LLC
Orthopedic · 120d
Cleared Feb 28, 2017
Biograph mMR with syngo MR E11P system software
K163234 · OUO
Siemens Medical Solutions USA, Inc.
Radiology · 103d
Cleared Feb 28, 2017
Virtual Occupational Therapy Application (VOTA)
K163245 · LXJ
Barron Associates, Inc.
Physical Medicine · 102d
Cleared Feb 28, 2017
Apex Dental Sensors
K163282 · MUH
Masterlink, LLC
Radiology · 99d
Cleared Feb 28, 2017
Biomet Fusion System
K163543 · OVD
Zimmer Biomet Spine, Inc.
Orthopedic · 74d
Cleared Feb 28, 2017
FIRMap Catheter
K163709 · MTD
Abbott Electrophysiology
Cardiovascular · 60d
Cleared Feb 28, 2017
Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set
K170008 · KNW
Cook Incorporated
Gastroenterology & Urology · 56d
Cleared Feb 28, 2017
Jac-Cell Medic testers
K170105 · GEI
Jac-Cell Medic
General & Plastic Surgery · 47d
Cleared Feb 28, 2017
BD Nexiva Diffusics Closed IV Catheter System
K170283 · FOZ
Becton, Dickinson and Company
General Hospital · 29d
Cleared Feb 27, 2017
proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA...
K161853 · JXG
Aesculap, Inc.
Neurology · 236d
Cleared Feb 27, 2017
Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies
K162903 · KWT
Exactech, Inc.
Orthopedic · 133d
Cleared Feb 27, 2017
Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP...
K162982 · LZA
Medline Industries, Inc.
General Hospital · 124d
Cleared Feb 27, 2017
Kyphon Xpede Bone Cement
K163032 · NDN
Medtronic, Inc.
Orthopedic · 119d
Cleared Feb 27, 2017
ComfortGuard Surgical Gown, i600, Film Reinforced
K163191 · FYA
Gri Medical & Electrical Technology...
General Hospital · 105d
Cleared Feb 27, 2017
BD PosiFlush Heparin Lock Flush Syringe
K163591 · NZW
Becton, Dickinson and Company
General Hospital · 69d
Cleared Feb 27, 2017
Flextra Steerable Introducer
K170373 · DYB
Rhythm Xience, Inc. (Rxi)
Cardiovascular · 20d
Cleared Feb 24, 2017
DT-100
K160358 · FLL
Mediana Co., Ltd.
General Hospital · 381d
Cleared Feb 24, 2017
HF 718BD X-Ray System
K160857 · KPR
Arquilla, Inc. Dba X-Cel X-Ray...
Radiology · 332d
Cleared Feb 24, 2017
Sonoma Fifth Metatarsal Repair System
K161371 · HSB
Sonoma Orthopedic Products, Inc.
Orthopedic · 283d