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
26233–26256 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared CT Apr 06, 2018
Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung
K170570 · IYE
Varian Medical Systems, Inc.
Radiology · 403d
Cleared Apr 06, 2018
DiaSpect Tm, DiaSpect Tm Cuvettes
K172173 · GKR
Ekf Diagnostic GmbH
Hematology · 261d
Cleared Apr 06, 2018
Medicant Mucosal Atomizer
K172956 · CCT
Medica Holdings, LLC
Anesthesiology · 192d
Cleared Apr 06, 2018
NovoGro
K173525 · MQV
Osteonovus, Inc.
Orthopedic · 143d
Cleared Apr 06, 2018
A. L. P. S. Clavicle Plating System
K173767 · HRS
Biomet, Inc.
Orthopedic · 116d
Cleared Apr 06, 2018
Clench Compression Staple
K173775 · JDR
F & A Foundation, LLC D.B.A. Reign...
Orthopedic · 115d
Cleared Apr 06, 2018
8mm Monopolar Curved Scissors
K180033 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 92d
Cleared Apr 06, 2018
FIBERGRAFT BG Matrix Bone Graft Substitute
K180080 · MQV
Prosidyan, Inc.
Orthopedic · 86d
Cleared Apr 06, 2018
NAVIO™ Surgical System (NAVIO system)
K180271 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 65d
Cleared Apr 06, 2018
Patriot Spinal Fixation System
K180324 · NKB
Valorus Spine
Orthopedic · 60d
Cleared Apr 06, 2018
Viveve RF System, Secure
K180584 · GEI
Viveve, Inc.
General & Plastic Surgery · 32d
Cleared Apr 06, 2018
PICO Single Use Negative Pressure Wound Therapy System
K180614 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 29d
Cleared Apr 06, 2018
PTFE SURGICAL SUTURE
K180630 · NBY
Omnia Spa
General & Plastic Surgery · 28d
Cleared Apr 05, 2018
Nano Varnish, Plaquit, Lightpaint on Surface
K162408 · EBD
Dreve Dentamid GmbH
Dental · 584d
Cleared Apr 05, 2018
Neodent Instrument Kits
K171713 · KCT
Jjgc Industria E Comercio DE...
General Hospital · 300d
Cleared Apr 05, 2018
Corin Optimized Positioning System (OPS™) Plan
K171847 · LLZ
Corin U.S.A. Limited
Radiology · 288d
Cleared Apr 05, 2018
Wedge Microcatheter
K172014 · DQY
MicroVention, Inc.
Cardiovascular · 276d
Cleared Apr 05, 2018
PENTAX Medical EPK-3000 Video Imaging System
K172156 · EOB
Pentax Medical
Ear, Nose, Throat · 261d
Cleared Apr 05, 2018
Bipolar Micro-Coagulation Forceps
K172368 · GEI
Gunter Bissinger Medizintechnik GmbH
General & Plastic Surgery · 241d
Cleared Apr 05, 2018
uWS-MI
K172998 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 190d
Cleared Apr 05, 2018
SIC invent Dental Implant Systems
K173207 · DZE
Sic Invent AG
Dental · 185d
Cleared Apr 05, 2018
GORE ENFORM Biomaterial
K173333 · OXF
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 164d
Cleared Apr 05, 2018
SENTIO MMG Gen 2
K173526 · PDQ
Medos International SARL
Neurology · 142d
Cleared Apr 05, 2018
VAMP Venous/Arterial Blood Management Protection System
K173586 · KRA
Edwards Lifesciences, LLC
Cardiovascular · 136d