Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
45457–45480 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 11, 2012
GLADIATOR PTA BALLOON DILATION CATHETER
K113681 · LIT
Boston Scientific
Cardiovascular · 27d
Cleared CT Jan 10, 2012
PREPEX SYSTEM
K103695 · HFX
Circ Medtech
Obstetrics & Gynecology · 389d
Cleared Jan 10, 2012
PROPATCH SOFT TISSUE REPAIR MATRIX
K110581 · FTM
Cryolife, Inc.
General & Plastic Surgery · 315d
Cleared Jan 10, 2012
TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT
K110971 · IYE
Navotek Medical, Ltd.
General & Plastic Surgery · 279d
Cleared Jan 10, 2012
I-ENDO DUAL
K111623 · EBW
Satelec - Acteon Group
Dental · 214d
Cleared Jan 10, 2012
NEO TITANIUM MESH, CTI-MEM
K111761 · JEY
Neobiotech Co., Ltd.
Dental · 201d
Cleared Jan 10, 2012
FINE JECT INSULIN PEN NEEDLE
K112332 · FMI
Twobiens Co., Ltd.
General Hospital · 151d
Cleared Jan 10, 2012
ALEUTIAN SYSTEM
K113138 · MAX
K2m, Inc.
Orthopedic · 77d
Cleared Jan 10, 2012
CORTRAK ENTERAL ACCESS DEVICE
K113351 · KNT
Corpak Medsystems
Gastroenterology & Urology · 57d
Cleared Jan 10, 2012
DSS STABILIZATION SYSTEM
K113625 · NKB
Paradigm Spine, LLC
Orthopedic · 33d
Cleared Jan 10, 2012
VOLUSON E6/E8/E8EXPERT/E10
K113758 · IYE
Ge Healthcare
General & Plastic Surgery · 20d
Cleared Jan 09, 2012
NEUROTECH PLUS
K112258 · GZJ
Bio-Medical Research, Ltd.
Neurology · 157d
Cleared Jan 09, 2012
APNEA RISK EVALUATION SYSTEM (ARES)
K112514 · MNR
Advanced Brain Monitoring, Inc.
Anesthesiology · 132d
Cleared Jan 09, 2012
LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2)...
K112960 · MBI
Cayenne Medical, Inc.
Orthopedic · 96d
Cleared CT Jan 09, 2012
SYNTHECEL DURA REPLACEMENT DEVICES
K113071 · GXQ
Synthes
Neurology · 84d
Cleared Jan 06, 2012
AVITA INFRARED THEROMETER WITH BLUETOOTH
K110559 · FLL
Avita Corporation
General Hospital · 312d
Cleared Jan 06, 2012
KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE
K111165 · ODA
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 255d
Cleared Jan 06, 2012
SONOTT FLOWLAB(R)
K111730 · DPW
Em-Tec GmbH
Radiology · 200d
Cleared Jan 06, 2012
SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE
K111861 · LLZ
Siemens Medical Systems USA
Radiology · 190d
Cleared Jan 06, 2012
TOUCHPACS SUITE
K112008 · LLZ
Touch Medical Solutions, Inc.
Radiology · 177d
Cleared Jan 06, 2012
MTA ANGELUS
K112046 · KIF
Angelus Industria DE Productos...
Dental · 172d
Cleared Jan 06, 2012
RADIANCE
K112060 · MUJ
Gmv Aerospace and Defence S.A.
Radiology · 171d
Cleared Jan 06, 2012
APTUS WRIST ARTHRODESIS PLATES
K112169 · HRS
Medartis AG
Orthopedic · 162d
Cleared Jan 06, 2012
ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER
K112301 · HSX
Materialise NV
Orthopedic · 149d