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
40513–40536 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 2013
SMARTFLOW CATHETER
K123605 · HCA
Mri Interventions, Inc.
Neurology · 268d
Cleared Aug 16, 2013
ENDO E CLASS
K123608 · EBW
Saeyang Microtech Co., Ltd.
Dental · 268d
Cleared Aug 16, 2013
TRS CRANIAL BONE VOID FILLER(TRS C-BVF)
K123633 · GXR
Tissue Regeneration Systems, Inc.
Neurology · 266d
Cleared Aug 16, 2013
COVAGEN
K123756 · KGN
Covalon Technologies, Ltd.
General & Plastic Surgery · 252d
Cleared Aug 16, 2013
INTERMITTENT PNEUMATIC COMPRESSION DEVICE
K123830 · JOW
Dalian Labtek Science & Development...
Cardiovascular · 247d
Cleared Aug 16, 2013
QUICKIE & ZIPPIE SERIES
K123975 · IOR
Sunrise Medical
Physical Medicine · 233d
Cleared Aug 16, 2013
VERIFY PROCESS INDICATOR FOR RELIANCE EPS
K130160 · JOJ
STERIS Corporation
General Hospital · 205d
Cleared Aug 16, 2013
D-LUX
K130163 · EBZ
DiaDent Group International
Dental · 205d
Cleared Aug 16, 2013
JIAJIAN CMN STIMULATOR
K130768 · BWK
Wuxi Jiajian Medical Instrument Co.,...
Neurology · 149d
Cleared Aug 16, 2013
NEWA SKIN THERAPY SYSTEM
K130793 · GEI
Endymion Medical, Ltd.
General & Plastic Surgery · 147d
Cleared Aug 16, 2013
TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)
K131052 · KNT
Actuated Medical, Inc.
Gastroenterology & Urology · 123d
Cleared Aug 16, 2013
QUATTRO GL SUTURE ANCHOR
K131325 · MBI
Cayenne Medical, Inc.
Orthopedic · 100d
Cleared Aug 16, 2013
SYMBIA
K131634 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 73d
Cleared Aug 16, 2013
6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET
K131687 · LJS
Medical Components, Inc.
General Hospital · 67d
Cleared Aug 16, 2013
INTELLIVUE PATIENT MONITOR
K131829 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 57d
Cleared Aug 16, 2013
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET
K132334 · LJS
Cook, Inc.
General Hospital · 21d
Cleared Aug 15, 2013
EBCHEK BLOOD GLUCOSE MONITORING SYSTEM
K122181 · NBW
Visgeneer, Inc.
Chemistry · 388d
Cleared Aug 15, 2013
NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN
K123766 · FMF
Novo Nordisk, Inc.
General Hospital · 251d
Cleared Aug 15, 2013
ANYONETM INTERNAL IMPLANT SYSTEM
K123988 · DZE
Megagen Implant Co., Ltd.
Dental · 232d
Cleared Aug 15, 2013
GYMFORM ABS-A-ROUND
K130074 · NGX
Well Brain International , Ltd.
Physical Medicine · 213d
Cleared Aug 15, 2013
GMK HINGE
K130299 · KRO
Medacta International
Orthopedic · 189d
Cleared Aug 15, 2013
KINEX BIOACTIVE
K130392 · MQV
Globus Medical, Inc.
Orthopedic · 181d
Cleared Aug 15, 2013
2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER
K130687 · DYB
Medical Components, Inc.
Cardiovascular · 155d
Cleared Aug 15, 2013
DYNASENSE SYSTEM
K130752 · KMI
Centauri Medical, Inc.
General Hospital · 149d