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
26713–26736 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 14, 2018
Siberian Fit
K172439 · GEX
Vydence
General & Plastic Surgery · 187d
Cleared Feb 14, 2018
SEURAT™ Universal Pedicle Screw System
K173185 · NKB
Ctl Medical Corporation
Orthopedic · 138d
Cleared Feb 14, 2018
TEMED Gas Diffuser
K173545 · HIF
Temed
Obstetrics & Gynecology · 90d
Cleared Feb 14, 2018
Sunrise 6200, Sunrise 7200
K173565 · LEJ
Jk Holding GmbH
General & Plastic Surgery · 89d
Cleared Feb 14, 2018
Sera
K173567 · EWO
Interacoustics A/S
Ear, Nose, Throat · 86d
Cleared Feb 14, 2018
Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
K173651 · KDJ
Fresenius Medical Care Renal...
Gastroenterology & Urology · 78d
Cleared Feb 14, 2018
Surgical Laser fibers
K180158 · GEX
Quanta System Spa
General & Plastic Surgery · 26d
Cleared Feb 13, 2018
Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical...
K171825 · GEI
Hunan Handlike Minimally Invasive...
General & Plastic Surgery · 239d
Cleared Feb 13, 2018
CT6485, CT12885
K172058 · JAK
Analogic Corporation
Radiology · 222d
Cleared Feb 13, 2018
Voyant 5mm Fusion Device
K172624 · GEI
Applied Medical Resources Corporation
General & Plastic Surgery · 165d
Cleared Feb 13, 2018
ENDOSOLV
K172839 · KIF
Septodont
Dental · 147d
Cleared Feb 13, 2018
Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G,...
K172870 · FLL
Hangzhou Hua'An Medical&Health...
General Hospital · 146d
Cleared Feb 13, 2018
DRI Hydrocodone Assay
K173195 · DJG
Microgenics Corporation
Toxicology · 134d
Cleared Feb 13, 2018
SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP
K173313 · ITI
Eurogreen International, Inc.
Physical Medicine · 117d
Cleared Feb 13, 2018
SupaChair Powered Wheelchair
K173315 · ITI
Eurogreen International, Inc.
Physical Medicine · 117d
Cleared Feb 13, 2018
Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic...
K173535 · ODP
Titan Spine, LLC
Orthopedic · 90d
Cleared Feb 13, 2018
MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM...
K173592 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Feb 13, 2018
QuickVue Influenza A+B
K180288 · PSZ
Quidel Corporation
Microbiology · 12d
Cleared Feb 12, 2018
SuRgical Planner (SRP)
K170793 · LLZ
Surgical Theater, LLC
Radiology · 333d
Cleared Feb 12, 2018
Zyston Strut Open Titanium Spacer System
K171495 · MAX
Zimmer Biomet Spine, Inc.
Orthopedic · 266d
Cleared CT Feb 12, 2018
ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro...
K171933 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 229d
Cleared Feb 12, 2018
MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
K172775 · OCW
Teleflexmedical, Inc.
Gastroenterology & Urology · 151d
Cleared Feb 12, 2018
Home Use Hair Removal Device/T1, T2, T3
K172883 · OHT
Shenzhen Mareal Tech Co., Ltd.
General & Plastic Surgery · 144d
Cleared Feb 12, 2018
CASCADIA Interbody System
K172941 · OVD
K2m
Orthopedic · 139d