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
34129–34152 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 03, 2015
Lotus Posterior Cervical/Thoracic Spinal System
K151705 · NKG
Spinal Elements, Inc.
Orthopedic · 71d
Cleared Sep 03, 2015
SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System
K151885 · NKG
Depuy Synthes, Inc.
Orthopedic · 56d
Cleared Sep 03, 2015
REDAPT¿ Revision Femoral System
K151902 · LZO
Smith & Nephew, Inc.
Orthopedic · 55d
Cleared Sep 03, 2015
Exactech Optetrak Logic Enhanced Assembly
K152170 · JWH
Exactech, Inc.
Orthopedic · 30d
Cleared Sep 03, 2015
MH01
K152220 · GEX
Quanta System Spa
General & Plastic Surgery · 27d
Cleared Sep 03, 2015
Ebony PTA .014 RX Pheripheral Dilatation Catheter
K152230 · LIT
Natec Medical
Cardiovascular · 27d
Cleared Sep 03, 2015
SpeqRT
K152250 · IYN
Signostics Limited
Radiology · 24d
Cleared Sep 03, 2015
S12 Digital Color Doppler Ultrasound System
K152396 · IYN
Sonoscape Medical Corp.
Radiology · 10d
Cleared Sep 02, 2015
HAMILTON-T1,HAMILTON-C1
K140939 · CBK
Hamilton Medical AG
Anesthesiology · 509d
Cleared Sep 02, 2015
CleanSmart Wound Cleanser
K142592 · FRO
Simple Science, LLC
General & Plastic Surgery · 352d
Cleared Sep 02, 2015
TempTraq TT-100
K143267 · FLL
Blue Spark Technologies, Inc.
General Hospital · 293d
Cleared Sep 02, 2015
FACT Medical Imaging Sysytem
K143586 · LLZ
Dexin Medical Imaging Technology Co.,...
Radiology · 258d
Cleared Sep 02, 2015
DirectInject
K143661 · GXP
Stryker
Neurology · 253d
Cleared Sep 02, 2015
Panorama Patient Monitoring Network
K150082 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 230d
Cleared Sep 02, 2015
Cardinal Health NPWT PRO HC
K150124 · OMP
Cardinalhealth
General & Plastic Surgery · 225d
Cleared Sep 02, 2015
V Series Monitoring System (including V12 and V21 Monitors)
K150352 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 203d
Cleared Sep 02, 2015
BD Single Use, Hypodermic Syringe
K151766 · FMF
Becton, Dickinson and Company
General Hospital · 64d
Cleared Sep 02, 2015
COMPACT INTUITIV Multiple-Use Pack
K151783 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 63d
Cleared Sep 02, 2015
Infinity CentralStation Wide
K151860 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 56d
Cleared Sep 02, 2015
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K151869 · DXN
Microlife Intellectual Property GmbH,...
Cardiovascular · 55d
Cleared Sep 02, 2015
TRUCLEAR Operative Hysteroscope 5C and Sheath 5C
K152143 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 30d
Cleared Sep 02, 2015
Fortress Pedicular Fixation System
K152148 · NKB
Spineology, Inc.
Orthopedic · 30d
Cleared Sep 02, 2015
The Belmont Hyperthermia Pump
K152208 · LGZ
Belmont Instrument Corporation
General Hospital · 26d
Cleared Sep 01, 2015
FibroScan
K150239 · IYO
Echosens
Radiology · 211d