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
21817–21840 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 2019
Carnation Ambulatory Monitor
K192556 · DSH
Bardy Diagnostics, Inc.
Cardiovascular · 30d
Cleared Oct 17, 2019
Reach and CQ'ENCE Circular Staplers
K192566 · GDW
Reach Surgical, Inc.
General & Plastic Surgery · 29d
Cleared Oct 16, 2019
Pitkar External Fixation System
K190486 · KTT
S.H.Pitkar Orthotools Pvt. , Ltd.
Orthopedic · 230d
Cleared Oct 16, 2019
Arthrex Minimally Invasive Ankle Fusion Plate
K190953 · HRS
Arthrex, Inc.
Orthopedic · 188d
Cleared Oct 16, 2019
Ventripoint Medical System Plus (VMS+) 3.0
K191493 · LLZ
Ventripoint Diagnostics , Ltd.
Radiology · 133d
Cleared Oct 16, 2019
SECURE Screw
K191771 · HWC
A.M. Surgical, Inc.
Orthopedic · 106d
Cleared Oct 16, 2019
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K192250 · JWY
Thermo Fisher Scientific
Microbiology · 58d
Cleared Oct 16, 2019
Focus 35C Detector, Trimax 35C Detector
K192512 · MQB
Iray Technology Taicang , Ltd.
Radiology · 34d
Cleared Oct 16, 2019
DigiX FDX
K192541 · KPR
Allengers Medical Systems Limited
Radiology · 30d
Cleared Oct 15, 2019
Vial Adapter Ø20 mm
K190149 · LHI
Avenir Performance Europeenne Medical...
General Hospital · 259d
Cleared Oct 15, 2019
Medtronic Transportation / Sterilization Cassettes
K190840 · KCT
Medtronic Sofamor Danek USA, Inc.
General Hospital · 197d
Cleared Oct 15, 2019
Infared Thermometer
K191251 · FLL
Shenzhen Calibeur Industries Co., Ltd.
General Hospital · 159d
Cleared Oct 15, 2019
Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm Module
K191326 · HRS
Arthrex, Inc.
Orthopedic · 152d
Cleared Oct 15, 2019
NuFACE Mini Device
K191672 · NFO
Carol Cole Company Dba Nuface
Neurology · 113d
Cleared Oct 15, 2019
TotalShield II Surgical Helmet System
K192194 · FYA
Zimmer Surgical, Inc.
General Hospital · 63d
Cleared Oct 15, 2019
DualX Lumbar Intervertebral Body Fusion Device
K192434 · MAX
Amplify Surgical, Inc.
Orthopedic · 40d
Cleared Oct 14, 2019
Echelon Endopath Staple Line Reinforcement
K190937 · OXC
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 187d
Cleared Oct 11, 2019
PMT Facet Screw
K183589 · MRW
Providence Medical Technology, Inc.
Orthopedic · 294d
Cleared Oct 11, 2019
Electronic Pulse Stimulator
K183674 · NUH
Shenzhen Leading Perfection...
Neurology · 288d
Cleared Oct 11, 2019
Protego Antimicrobial Wound Dressing
K183681 · FRO
Global Health Solutions (Dba Turn...
General & Plastic Surgery · 287d
Cleared Oct 11, 2019
McLean-Ring Enteral Feeding Tube Set
K190084 · KNT
Cook Incorporated
Gastroenterology & Urology · 267d
Cleared Oct 11, 2019
F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask...
K190713 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 206d
Cleared Oct 11, 2019
NXPRO Neuromuscular Electrical Stimulation Device
K191181 · NGX
Neux Technologies, Inc.
Physical Medicine · 162d
Cleared Oct 11, 2019
Spectra Cashmere
K191208 · HGX
Uzinmedicare Co.
Obstetrics & Gynecology · 158d