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
45217–45240 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 07, 2012
Z FLEX-270TM STEERABLE SHEATH
K112541 · DRA
Great Batch Medical
Cardiovascular · 159d
Cleared Feb 07, 2012
SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS...
K112591 · FRG
Safe Secure Packaging Co., Ltd.
General Hospital · 153d
Cleared Feb 07, 2012
PROPHY-MATE NEO
K112673 · EFB
Nakanishi, Inc.
Dental · 146d
Cleared Feb 07, 2012
TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT
K113021 · GEH
CSA Medical, Inc.
General & Plastic Surgery · 119d
Cleared Feb 07, 2012
TLINK DATA MANAGEMENT SYSTEM (DMS)
K113214 · DXJ
Terumo Cardiovascular Systems Corp.
Cardiovascular · 99d
Cleared Feb 07, 2012
MEDICAL IMAGE PROCESSING UNIT
K113360 · EAP
Humanray Co,Ltd
Radiology · 85d
Cleared Feb 07, 2012
ORTHO-1(NOT FINALIZED)
K113401 · DYH
Bisco, Inc.
Dental · 82d
Cleared Feb 06, 2012
CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS
K111481 · OQI
Corin USA
Orthopedic · 255d
Cleared Feb 06, 2012
PATHWAY AVID
K111726 · MAX
Custom Spine, Inc.
Orthopedic · 231d
Cleared Feb 06, 2012
FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD...
K111890 · NBW
Taidoc Technology Corporation
Chemistry · 220d
Cleared Feb 06, 2012
AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE
K111959 · MPN
Aesculap, Inc.
General & Plastic Surgery · 210d
Cleared Feb 06, 2012
NAVIAID ICVI-F,S,B,R DEVICE
K112106 · ODC
Smart Medical Systems , Ltd.
Gastroenterology & Urology · 199d
Cleared Feb 06, 2012
AQUILEX FLUID CONTROL SYSTEM H112
K112642 · HIG
W.O.M. World of Medicine AG
Obstetrics & Gynecology · 147d
Cleared Feb 06, 2012
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K113100 · LZA
Maxter Glove Manufacturing Sdn Bhd
General Hospital · 110d
Cleared Feb 06, 2012
VASCULAR SONO
K113196 · DYB
PAJUNK GmbH Medizintechnologie
Cardiovascular · 98d
Cleared Feb 06, 2012
ROTOR-GENE Q MDX
K113319 · OOI
QIAGEN GmbH
Microbiology · 88d
Cleared Feb 06, 2012
ARTUS INFL A/B RG RT-PCR KIT
K113323 · OCC
QIAGEN GmbH
Microbiology · 88d
Cleared Feb 06, 2012
PERIMETER INTERBODY FUSION DEVICE
K113642 · MAX
Medtronic Sofamor Danek USA
Orthopedic · 56d
Cleared Feb 06, 2012
PATIENT MONITOR
K113653 · MHX
Edan Instruments, Inc.
Cardiovascular · 56d
Cleared Feb 06, 2012
ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIRE
K113716 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 49d
Cleared Feb 06, 2012
METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET
K113752 · KWD
Solana Surgical, LLC
Orthopedic · 47d
Cleared Feb 06, 2012
CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM
K113762 · HRS
Arthrosurface, Inc.
Orthopedic · 47d
Cleared Feb 06, 2012
ZIO PATCH
K113862 · DSH
iRhythm Technologies, Inc.
Cardiovascular · 38d
Cleared Feb 06, 2012
HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET
K120029 · KWD
Solana Surgical, LLC
Orthopedic · 33d