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
44089–44112 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 13, 2012
AQUILION PREMIUM
K120546 · JAK
Toshiba Medical Systems Corporation,...
Radiology · 111d
Cleared Jun 13, 2012
MEDART 620
K120573 · GEX
Medart A/S
General & Plastic Surgery · 107d
Cleared Jun 13, 2012
DURABLUE STERILIZATION WRAP
K120658 · FRG
Cardinal Health200, LLC
General Hospital · 100d
Cleared Jun 13, 2012
CONCIERGE GUIDING CATHETER
K121051 · DQY
Merit Medical Systems, Inc.
Cardiovascular · 68d
Cleared Jun 13, 2012
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
K121129 · MAX
Spineology, Inc.
Orthopedic · 61d
Cleared Jun 13, 2012
EXPRESSION INFORMATION PORTAL
K121424 · MWI
Invivo Corporation
Cardiovascular · 30d
Cleared Jun 13, 2012
MINI MAXLOCK EXTREME PLATING SYSTEM
K121437 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 29d
Cleared Jun 13, 2012
TUBECLEAR
K121571 · KNT
Actuated Medical, Inc.
Gastroenterology & Urology · 15d
Cleared CT Jun 12, 2012
AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES
K113628 · DXX
Catheter Robotics, Inc.
Cardiovascular · 187d
Cleared Jun 12, 2012
AMPLATZER VASCULAR PLUG 4
K113658 · KRD
Aga Medical Corp.
Cardiovascular · 183d
Cleared Jun 12, 2012
EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV
K120045 · FYA
Exact Medical Manufacturing, Inc.
General Hospital · 158d
Cleared Jun 12, 2012
STERILE DISPOSABLES FOR MER
K120098 · GZL
Alpha Omega Engineering , Ltd.
Neurology · 152d
Cleared Jun 12, 2012
CONMED SUREFIT DUAL DISPERSIVE ELECTRODE
K120322 · GEI
Conmed Corporation
General & Plastic Surgery · 131d
Cleared Jun 12, 2012
MACROLYTE DISPERSIVE ELECTRODE
K120476 · GEI
Conmed Corporation
General & Plastic Surgery · 117d
Cleared Jun 12, 2012
INVENT SNORING DEVICE
K120665 · LWF
Ventus Medical, Inc.
Ear, Nose, Throat · 99d
Cleared Jun 12, 2012
DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT
K120695 · EMB
Dentist IN A Box Pty., Ltd.
Dental · 97d
Cleared Jun 12, 2012
MODULTH SLK
K120769 · LNS
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 12, 2012
NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB...
K120772 · HRS
Zimmer GmbH
Orthopedic · 90d
Cleared Jun 12, 2012
DISCOVERY CT750 HD
K120833 · JAK
Ge Medical Systems, LLC
Radiology · 85d
Cleared Jun 12, 2012
RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU...
K121145 · JOW
Renu Medical, Inc.
Cardiovascular · 57d
Cleared Jun 12, 2012
MULTIARRAY KIT
K121249 · MOS
Paramed S.R.L.
Radiology · 48d
Cleared Jun 12, 2012
AGILITY
K121328 · IYE
Elekta , Ltd.
Radiology · 40d
Cleared Jun 12, 2012
LITECURE THERAPY COMPACT
K121487 · ILY
Litecure, LLC
Physical Medicine · 25d
Cleared Jun 11, 2012
BLEASE700/900 SERIES VENTILATORS
K112729 · CBK
Spacelabs Healthcare
Anesthesiology · 265d