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
64033–64056 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2005
GP GENERAL PURPOSE DRAINAGE CATHETER
K053245 · FGE
Uresil, LLC
Gastroenterology & Urology · 29d
Cleared Dec 19, 2005
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
K052906 · PHX
Zimmer, Inc.
Orthopedic · 66d
Cleared Dec 19, 2005
SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH
K053066 · FTL
Genzyme Corporation
General & Plastic Surgery · 48d
Cleared Dec 19, 2005
ESTECH COBRA BIPOLAR SYSTEM
K053100 · GEI
Endoscopic Technologies, Inc.
General & Plastic Surgery · 46d
Cleared Dec 19, 2005
KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES
K053262 · ERL
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 27d
Cleared Dec 16, 2005
FC 700 FETAL MONITOR
K043597 · HGM
Bionet Co., Ltd.
Obstetrics & Gynecology · 352d
Cleared Dec 16, 2005
FC 1400 FETAL MONITOR
K043598 · HGM
Bionet Co., Ltd.
Obstetrics & Gynecology · 352d
Cleared Dec 16, 2005
GRAFTON DBM
K051195 · MBP
Osteotech, Inc.
Orthopedic · 220d
Cleared Dec 16, 2005
MASTERGRAFT PUTTY BONE VOID FILLER
K051386 · MQV
Medtronic Vascular
Orthopedic · 203d
Cleared Dec 16, 2005
GRAFTCAGE TLX
K051781 · MQP
Osteotech, Inc.
Orthopedic · 168d
Cleared Dec 16, 2005
MODEL 750E SERIES MONITOR
K051896 · MWI
Cas Medical Systems, Inc.
Cardiovascular · 156d
Cleared Dec 16, 2005
ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)
K052007 · CFR
Horiba Abx
Chemistry · 144d
Cleared Dec 16, 2005
REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA
K052081 · DWF
Estech, Inc.
Cardiovascular · 136d
Cleared Dec 16, 2005
LUMIMED MONOCHROME LCD MONITOR, MODELS MM 20, MM 30 AND MM50
K052120 · LLZ
Heeyoung Co., Ltd.
Radiology · 134d
Cleared Dec 16, 2005
ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.)
K052160 · DSI
Welch Allyn, Inc.
Cardiovascular · 129d
Cleared Dec 16, 2005
MULTIPLE (TOOTH DESENSITIZER)
K052263 · LBH
Cosmedent, Inc.
Dental · 119d
Cleared Dec 16, 2005
READMYHEART, MODEL RMH2.0
K052303 · DPS
Dailycare Biomedical, Inc.
Cardiovascular · 114d
Cleared Dec 16, 2005
BEAMER PAINLOW INFRARED LIGHT TREATMENT SYSTEM
K052307 · ILY
Beamline Corporation
Physical Medicine · 114d
Cleared Dec 16, 2005
MEDTRONIC M2 MAGNET ADJUSTMENT TOOL
K052386 · JXG
Medtronic Neurosurgery
Neurology · 107d
Cleared Dec 16, 2005
BREATHEX OMEGA CPAP DEVICE, MODEL 322
K052597 · BZD
Hoffman Laboratories, LLC
Anesthesiology · 86d
Cleared Dec 16, 2005
STARLITE 2006
K052604 · GEX
Laser Dental Innovations
General & Plastic Surgery · 86d
Cleared Dec 16, 2005
BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20
K052646 · MNW
Biospace Corporation Limited
Gastroenterology & Urology · 81d
Cleared Dec 16, 2005
ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.
K052694 · JHI
Ind Diagnostic, Inc.
Chemistry · 79d
Cleared Dec 16, 2005
ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350
K052727 · DXN
Rossmax International , Ltd.
Cardiovascular · 78d