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
26377–26400 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 2018
ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR,...
K180473 · OWB
Ecotron Co., Ltd.
Radiology · 29d
Cleared Mar 22, 2018
Arthrex UNIVERS REVERS COATED BASEPLATE
K172371 · PHX
Arthrex, Inc.
Orthopedic · 227d
Cleared Mar 22, 2018
Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter
K173105 · ODC
Cook Incorporated
Gastroenterology & Urology · 174d
Cleared Mar 22, 2018
Alamo® C
K173128 · ODP
Alliance Partners, LLC
Orthopedic · 174d
Cleared Mar 22, 2018
SENTIO MMG Pedicle Access Needles
K173134 · PDQ
Medos International SARL
Neurology · 174d
Cleared Mar 22, 2018
Monarch Endoscopy Platform (Monarch Platform)
K173760 · EOQ
Auris Surgical Robotics, Inc.
Ear, Nose, Throat · 101d
Cleared Mar 22, 2018
Granada Medium
K173903 · PQZ
Hardy Diagnostics
Microbiology · 90d
Cleared Mar 22, 2018
Test of Variables of Attention (T.O.V.A.)
K173915 · LQD
The Tova Company
Neurology · 90d
Cleared Mar 22, 2018
Diazyme Lipoprotein (a) Assay
K180074 · DFC
Diazyme Laboratories, Inc.
Chemistry · 71d
Cleared Mar 22, 2018
Cortina [MAX] Lumbar Cage System
K180431 · MAX
Neurostructures, Inc.
Orthopedic · 34d
Cleared Mar 22, 2018
Tumark Vision
K180443 · NEU
Somatex Medical Technologies GmbH
General & Plastic Surgery · 30d
Cleared Mar 22, 2018
Bio-Medicus Adult Cannulae and Introducer
K180453 · DWF
Medtronic, Inc.
Cardiovascular · 30d
Cleared Mar 22, 2018
Bio-Medicus Adult Cannulae Kit
K180456 · DWF
Medtronic, Inc.
Cardiovascular · 30d
Cleared Mar 22, 2018
HemosIL Factor XII Deficient Plasma
K180486 · GJT
Instrumentation Laboratory CO
Hematology · 27d
Cleared Mar 21, 2018
P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil
K163661 · MOS
Rapid Biomedical GmbH
Radiology · 449d
Cleared Mar 21, 2018
Captura® Disposable Hot Biopsy Forceps
K171973 · KGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 264d
Cleared Mar 21, 2018
DROPLET PEN NEEDLE
K171982 · FMI
Htl-Strefa S.A
General Hospital · 264d
Cleared Mar 21, 2018
WillCeph
K172168 · LLZ
Hdx Will Corp.
Radiology · 246d
Cleared Mar 21, 2018
Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator...
K172611 · JAQ
Varian Medical Systems, Inc.
Radiology · 202d
Cleared Mar 21, 2018
Mammomat Revelation
K173408 · MUE
Siemens Medi Cal Solutions, Inc.
Radiology · 140d
Cleared Mar 21, 2018
Element System with IBT Electrodes
K173571 · GXY
Infinite Biomedical Technologies, LLC
Neurology · 121d
Cleared Mar 21, 2018
SOMATOM Edge Plus
K173607 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 120d
Cleared Mar 21, 2018
Mimics inPrint
K173619 · LLZ
Materialise NV
Radiology · 119d
Cleared Mar 21, 2018
DermaScalp Laser Cap
K173846 · OAP
Dermascalp, LLC
General & Plastic Surgery · 92d