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
64081–64104 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 2005
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION
K053197 · HCG
Cordis Neurovascular, Inc.
Neurology · 29d
Cleared Dec 15, 2005
ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT
K053250 · GZB
Advanced Neuromodulation Systems
Neurology · 24d
Cleared Dec 15, 2005
MENTOR ARIS SUPRAPUBIC SURGICAL KIT
K053296 · OTN
Mentor Corporation
Gastroenterology & Urology · 20d
Cleared Dec 15, 2005
FUTURABOND NR SINGLE DOSE
K053392 · KLE
Voco GmbH
Dental · 10d
Cleared Dec 14, 2005
BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178
K052087 · CAH
Ag Industries
General Hospital · 134d
Cleared Dec 14, 2005
DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406
K052259 · GEH
Schering-Plough Healthcare Products,...
General & Plastic Surgery · 117d
Cleared Dec 14, 2005
TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM
K052503 · MMI
Bayer Healthcare, LLC
Chemistry · 92d
Cleared Dec 14, 2005
FU HONG INDUSTRIES LIMITED SOOTHER TEETHER
K052531 · KKO
Fu Hong Industries , Ltd.
Dental · 90d
Cleared Dec 14, 2005
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323
K052645 · GTQ
Ortho-Clinical Diagnostics
Microbiology · 79d
Cleared Dec 14, 2005
TECO ISE REAGENT SET FOR CX SYSTEM
K052724 · JGS
Teco Diagnostics
Chemistry · 76d
Cleared Dec 14, 2005
PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20
K053011 · DRX
Bio Protech, Inc.
Cardiovascular · 49d
Cleared Dec 14, 2005
VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN
K053097 · LON
bioMerieux, Inc.
Microbiology · 41d
Cleared Dec 14, 2005
NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800
K053141 · ETN
The Magstim Company , Ltd.
Ear, Nose, Throat · 35d
Cleared Dec 14, 2005
QUICKVUE INFLUENZA A + B TEST
K053146 · PSZ
Quidel Corp.
Microbiology · 34d
Cleared Dec 14, 2005
ISE INDIRECT NA, K, CL FOR GEN.2
K053165 · JGS
Roche Diagnostics Corp.
Chemistry · 30d
Cleared Dec 14, 2005
SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT
K053199 · GXN
Synthes (Usa)
Neurology · 28d
Cleared Dec 14, 2005
NEXA BONE SCREW SYSTEM
K053394 · HWC
Nexa Orthopedics, Inc.
Orthopedic · 8d
Cleared Dec 13, 2005
WINNER SELF SEAL STERILIZATION POUCH
K051242 · KCT
Winner Medical (Usa), Inc.
General Hospital · 214d
Cleared Dec 13, 2005
LMA FASTRACH ETT SINGLE USE
K051993 · BTR
The Laryngeal Mask Co., Ltd.
Anesthesiology · 141d
Cleared Dec 13, 2005
TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM
K052233 · BTR
Etview , Ltd.
Anesthesiology · 118d
Cleared Dec 13, 2005
VASCULAR SOLUTIONS SKYWAY SUPPORT CATHETER
K052258 · DQY
Vascular Solutions, Inc.
Cardiovascular · 116d
Cleared Dec 13, 2005
DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE
K052289 · LIH
Biowave Corporation
Neurology · 112d
Cleared Dec 13, 2005
STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2
K052522 · MNW
Stayhealthy, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 13, 2005
STARDUST II
K052573 · MNR
Respironics, Inc.
Anesthesiology · 85d