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
39865–39888 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 2013
FIRMAP CATHETER
K130827 · MTD
Topera, Inc.
Cardiovascular · 219d
Cleared Oct 31, 2013
AMPCARE ESP THERAPY SYSTEM
K131222 · IPF
Ampcare, LLC
Physical Medicine · 184d
Cleared Oct 31, 2013
OSSEOFUSE DENTAL IMPLANT SYSTEM
K131748 · DZE
Osseofuse, Inc.
Dental · 139d
Cleared Oct 31, 2013
NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE...
K131894 · GEX
Nidek Co., Ltd.
General & Plastic Surgery · 128d
Cleared CT Oct 31, 2013
OFFROAD RE-ENTRY CATHETER SYSTEM
K131914 · PDU
Boston Scientific Corp
Cardiovascular · 127d
Cleared Oct 31, 2013
GSB GLOBAL SPINAL BALANCE SYSTEM
K132014 · NKB
Nuvasive, Inc.
Orthopedic · 122d
Cleared Oct 31, 2013
IPS E.MAX CAD ABUTMENT SOLUTIONS
K132209 · NHA
Ivoclar Vivadent, AG
Dental · 107d
Cleared Oct 31, 2013
ALTUS SPINE PEDICLE SCREW SYSTEM
K132280 · MNI
Altus Partners
Orthopedic · 100d
Cleared Oct 31, 2013
PAXERAPACS
K132586 · LLZ
Paxeramed
Radiology · 76d
Cleared Oct 31, 2013
UNIQUE
K132705 · IYE
Varian Medical Systems, Inc.
Radiology · 63d
Cleared Oct 31, 2013
MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)
K132924 · DTE
Medtronic, Inc.
Cardiovascular · 43d
Cleared Oct 31, 2013
DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING...
K132995 · DWF
Medtronic, Inc.
Cardiovascular · 37d
Cleared Oct 30, 2013
PLASMAFIT ACETABULAR CUP AND VITELENE INSERT
K122783 · OQG
Aesculap Implant System, Inc.
Orthopedic · 414d
Cleared Oct 30, 2013
DIPLOMAT
K130534 · EIA
Diplomat Dental S.R.O.
Dental · 243d
Cleared Oct 30, 2013
ARTHREX UNIVERS II CA HEADS
K130675 · HSD
Arthrex, Inc.
Orthopedic · 231d
Cleared Oct 30, 2013
SPIROTEL
K130784 · BZG
Mir Medical Intl. Research Srl
Anesthesiology · 223d
Cleared Oct 30, 2013
U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTER
K131116 · JWH
United Orthopedic Corporation
Orthopedic · 191d
Cleared Oct 30, 2013
OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS
K131719 · HLJ
Medical Devices (Pvt) , Ltd.
Ophthalmic · 140d
Cleared Oct 30, 2013
AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS
K131893 · FSY
Ajw Technology Consultants, Inc.
General & Plastic Surgery · 127d
Cleared Oct 30, 2013
MESO BILAYER SURGICAL MESH
K132025 · FTM
Kensey Nash Corporation Dba Dsm...
General & Plastic Surgery · 121d
Cleared Oct 30, 2013
VENOUS HARDSHELL CARDIOTOMY RESERVOIR
K132166 · DTN
Maquet Cardiopulmonary, AG
Cardiovascular · 110d
Cleared Oct 30, 2013
FLOWER BONE SCREW SET
K132248 · HWC
Flower Orthopedics Corporation
Orthopedic · 103d
Cleared Oct 30, 2013
STENTBOOST REL. 4
K132305 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 98d
Cleared Oct 30, 2013
MULTIVIEW
K132316 · LLZ
Hologic, Inc.
Radiology · 97d