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
42097–42120 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 07, 2013
ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM
K120708 · NBW
Cilag GmbH International
Chemistry · 336d
Cleared Feb 07, 2013
GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT
K120922 · IPF
Selectivemed Components, Inc.
Physical Medicine · 317d
Cleared Feb 07, 2013
0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE
K121050 · NGT
Becton, Dickinson & CO
General Hospital · 307d
Cleared Feb 07, 2013
OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE
K121818 · GXN
Oxford Performance Materials
Neurology · 232d
Cleared CT Feb 07, 2013
GENASIS SCANVIEW SYSTEM
K122554 · NTH
Applied Spectral Imaging , Ltd.
Pathology · 170d
Cleared Feb 07, 2013
BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208
K122587 · DRC
St Jude Medical
Cardiovascular · 167d
Cleared Feb 07, 2013
TOXCUP DRUG SCREEN CUP
K122633 · LDJ
Branan Medical Corp.
Chemistry · 162d
Cleared Feb 07, 2013
SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM
K122822 · NQW
Spectrum Spine, LLC
Orthopedic · 146d
Cleared Feb 07, 2013
COMPRESSYN STAPLE
K122871 · JDR
Dallen Medical, Inc.
Orthopedic · 141d
Cleared Feb 07, 2013
MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM
K123206 · ODP
Maxim Surgical
Orthopedic · 118d
Cleared Feb 07, 2013
AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY...
K123216 · DPT
Aimago SA
Cardiovascular · 115d
Cleared Feb 07, 2013
SPINEOLOGY SPINOUS PROCESS PLATE
K123232 · KWP
Spineology, Inc.
Orthopedic · 114d
Cleared Feb 07, 2013
RELIANCE SPINAL SCREW SYSTEM
K123521 · MNI
Reliance Medical Systems, LLC
Orthopedic · 84d
Cleared Feb 07, 2013
XIPHOS
K123969 · MAX
Difusion Technologies
Orthopedic · 43d
Cleared Feb 07, 2013
ESPIN
K130057 · HRX
Nlt Spine, Ltd.
Orthopedic · 29d
Cleared Feb 06, 2013
ASAHI REXEED-SX/LX SERIES DIALYZER
K121409 · KDI
Asahi Kasei Medical Co., Ltd.
Gastroenterology & Urology · 271d
Cleared Feb 06, 2013
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP
K122718 · GTY
Becton, Dickinson and Company
Microbiology · 154d
Cleared Feb 06, 2013
EEGER4 MODEL 4.3
K122879 · HCC
Eeg Software, LLC
Neurology · 140d
Cleared Feb 06, 2013
GE DATEX-OHMEDA AVANCE CS2
K123125 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 125d
Cleared Feb 06, 2013
SHERPA PAK CARDIAC TRANSPORT SYSTEM
K123326 · MSB
Paragonix Technologies, Inc.
Gastroenterology & Urology · 103d
Cleared Feb 06, 2013
TRC-NW300 NON-MYDRIATIC RETINAL CAMERA
K123460 · HKI
Topcon Medical Systems, Inc.
Ophthalmic · 89d
Cleared Feb 06, 2013
VISUAL-ICE CRYOABLATION SYSTEM
K123865 · GEH
Galil Medical, Inc.
General & Plastic Surgery · 51d
Cleared Feb 06, 2013
CAAS INTRAVASCULAR
K123970 · LLZ
Pie Medical Imaging BV
Radiology · 42d
Cleared Feb 06, 2013
APLIO 500/400/300 V3.0
K123992 · IYN
Toshibamedical Systems Corporation
Radiology · 42d