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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
63361–63384 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 2006
HYPEROX 101
K053498 · CBF
Wjo, Inc.
Anesthesiology · 89d
Cleared Mar 15, 2006
ELITE ELECTROMED L.I.T.E. 4/1
K053507 · NHN
Elite Electromedical
Physical Medicine · 89d
Cleared Mar 15, 2006
SMOOTHSHAPES
K053611 · NUV
Bicellulase, Inc.
General & Plastic Surgery · 78d
Cleared Mar 15, 2006
SURGISIS OCULAR GRAFT
K053622 · NXM
Iop, Inc.
Ophthalmic · 77d
Cleared Mar 15, 2006
SYNERGEYES PS HYBRID CONTACT LENS
K060102 · HQD
Synergeyes, Inc.
Ophthalmic · 61d
Cleared Mar 15, 2006
PRISMATIK CLINICAL ZIRCONIA
K060104 · EIH
Glidewell Laboratories
Dental · 61d
Cleared Mar 15, 2006
ONCOR EXPRESSION
K060226 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 44d
Cleared Mar 15, 2006
POWDER-FREE BLACK LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (50...
K060229 · LYY
Shun Thai Rubber Gloves Industry...
General Hospital · 44d
Cleared Mar 15, 2006
MCCUE ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM
K060234 · GEX
Mccue Plc
General & Plastic Surgery · 44d
Cleared Mar 15, 2006
IQPACS
K060263 · LLZ
S.C. Info World S.R.L.
Radiology · 42d
Cleared Mar 15, 2006
PLANMECA PROMAX 3D
K060328 · MUH
Planmeca Oy
Radiology · 34d
Cleared Mar 15, 2006
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE WITH OFFSET ADAPTERS
K060360 · KRO
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Mar 15, 2006
MEDRAD 3.0T ECOIL IMAGING SYSTEM
K060401 · MOS
Medrad, Inc.
Radiology · 28d
Cleared Mar 15, 2006
8F SHERPA NX GUIDE CATHETER
K060418 · DQY
Medtronic Vascular
Cardiovascular · 26d
Cleared Mar 15, 2006
TDM CONTROL SET
K060429 · JJY
Roche Diagnostics Corp.
Chemistry · 22d
Cleared Mar 15, 2006
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
K060572 · DQY
Boston Scientific Corporation
Cardiovascular · 9d
Cleared Mar 14, 2006
NEXUS LIGATING CLIP
K053255 · FZP
Microsurgical Laboratories,Inc.Dba...
General & Plastic Surgery · 113d
Cleared Mar 14, 2006
BTI INTERNA DENTAL IMPLANT SYSTEM
K053355 · DZE
B.T.I. Biotechnology Institute, Sl.
Dental · 102d
Cleared Mar 14, 2006
POLARIS WR, ST APPLICATOR
K053616 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 76d
Cleared Mar 14, 2006
MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE)
K053636 · GAM
Mani, Inc.
General & Plastic Surgery · 75d
Cleared Mar 14, 2006
SURGICOUNT SAFETY-SPONGE SYSTEM
K060076 · LWH
Surgicount Medical
General & Plastic Surgery · 63d
Cleared Mar 14, 2006
INSPIRSTAR IS02 MICROCURRENT STIMULATOR
K060368 · GZJ
Inspirstar, Inc.
Neurology · 29d
Cleared Mar 14, 2006
IDEAL LIFE BP-MANAGER, MODEL BPM 0001
K060504 · DXN
Ideal Life, Inc.
Cardiovascular · 15d
Cleared Mar 13, 2006
STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204
K051596 · NBC
Nanogen, Inc.
Chemistry · 270d