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
37921–37944 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared CT Jun 13, 2014
WINX SLEEP THERAPY SYSTEM
K132003 · OZR
Apnicure, Inc.
Anesthesiology · 347d
Cleared Jun 13, 2014
CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION
K132524 · JAK
Philips Medical Systems
Radiology · 305d
Cleared Jun 13, 2014
ONCENTRA BRACHY
K132816 · MUJ
Nucletron B.V.
Radiology · 277d
Cleared Jun 13, 2014
IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST
K132978 · PHJ
Sequenom, Inc.
Pathology · 263d
Cleared Jun 13, 2014
SENYINT PACS
K133098 · LLZ
Dalian Senyint Digital Medical System...
Radiology · 256d
Cleared Jun 13, 2014
KALARE
K133553 · JAA
Toshiba America Medical Systems, In.C
Radiology · 206d
Cleared Jun 13, 2014
CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM
K133661 · BZQ
Earlysense, Ltd.
Anesthesiology · 196d
Cleared Jun 13, 2014
BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MM
K133884 · DZE
Biodenta Swiss AG
Dental · 175d
Cleared Jun 13, 2014
U2 FEMORAL COMPONENT, CR, POROUS COATED
K140075 · MBH
United Orthopedic Corp.
Orthopedic · 151d
Cleared Jun 13, 2014
EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM
K140312 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 126d
Cleared Jun 13, 2014
740 SELECT
K140430 · MWI
Cas Medical Systems, Inc.
Cardiovascular · 114d
Cleared Jun 13, 2014
SU-POR SURGICAL IMPLANT
K140437 · KKY
Poriferous, LLC
General & Plastic Surgery · 112d
Cleared Jun 13, 2014
MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)
K140462 · GWO
Synthes USA Products, LLC
Neurology · 109d
Cleared Jun 13, 2014
MR ELASTOGRAPHY
K140666 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 87d
Cleared Jun 13, 2014
BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE...
K140759 · MAX
Medos International SARL
Orthopedic · 79d
Cleared Jun 13, 2014
CELERITY SYSYEM
K140799 · LJS
Medcomp (Medical Components, Inc.)
General Hospital · 74d
Cleared Jun 13, 2014
PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K140960 · LLZ
Hologic, Inc.
Radiology · 59d
Cleared Jun 13, 2014
LZI HYDROCODONE
K141055 · DJG
Lin-Zhi International, Inc.
Toxicology · 50d
Cleared Jun 13, 2014
ACUMED HAND FRACTURE SYSTEM
K141383 · HRS
Acumed, LLC
Orthopedic · 17d
Cleared Jun 13, 2014
ALERE I INFLUENZA A & B
K141520 · OCC
Alere Scarborough, Inc D/B/A Binax, Inc.
Microbiology · 4d
Cleared Jun 12, 2014
GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG
K132375 · GCJ
Genicon
General & Plastic Surgery · 317d
Cleared Jun 12, 2014
TERUMO SURFLO I.V. CATHETER
K133280 · FOZ
Terumo (Philippines) Corporation
General Hospital · 230d
Cleared Jun 12, 2014
JIAWANG
K140239 · LYZ
Jiawang Glove Co., Ltd.
General Hospital · 133d
Cleared Jun 12, 2014
ZHAOFENG
K140240 · LYZ
Zhaofeng Glove Co., Ltd.
General Hospital · 133d