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
70249–70272 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 2004
MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
K032235 · NBC
Biosite Incorporated
Chemistry · 191d
Cleared Jan 28, 2004
3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR
K032263 · DZE
Implant Innovations, Inc.
Dental · 189d
Cleared Jan 28, 2004
RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100
K032882 · MWJ
Recom Managed Systems, Inc.
Cardiovascular · 135d
Cleared Jan 28, 2004
AC-1 SP02 ADAPTOR CABLE, MODEL AC-1
K033349 · DQA
Masimo Corp.
Anesthesiology · 100d
Cleared Jan 28, 2004
CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS...
K033447 · NEU
Mri Devices Corp.
General & Plastic Surgery · 91d
Cleared Jan 28, 2004
EVOLVE RADIAL PLATE
K033456 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Jan 28, 2004
ASIA PACIFIC LATEX SDN. BHD. POWDER FREE LATEX EXAMINATION GLOVES
K033530 · LYY
Asia Pacific Latex Sdn Bhd
General Hospital · 79d
Cleared Jan 28, 2004
ASIA PACIFIC LATEX SDN. BHD. POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
K033532 · LYY
Asia Pacific Latex Sdn Bhd
General Hospital · 79d
Cleared Jan 28, 2004
SKY BONE EXPANDER SYSTEM
K034037 · HRX
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 30d
Cleared Jan 28, 2004
SONOLINE G50 AND G60 S DIAGNOSTIC ULTRASOUND SYSTEMS
K040060 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Jan 27, 2004
AC APPLICATOR, AURORA AC
K032514 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 166d
Cleared Jan 27, 2004
DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G...
K033381 · MED
Discus Dental, Inc.
General Hospital · 97d
Cleared Jan 27, 2004
PLUS PIVOT LINK UNIVERSAL SYSTEM
K033508 · MNI
Spine Vision, Inc.
Orthopedic · 82d
Cleared Jan 27, 2004
NDI PASSIVE SPHERES
K033621 · HAW
Northern Digital, Inc.
Neurology · 70d
Cleared Jan 27, 2004
SHIRAZ-JAVA SPINAL FIXATION SYSTEM
K033772 · MNI
Spine Next America
Orthopedic · 55d
Cleared Jan 27, 2004
HEEL SNUGGLER, MODEL 99047
K040044 · MPO
Respironics, Inc.
Physical Medicine · 15d
Cleared Jan 26, 2004
P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)
K032112 · BTR
Portex , Ltd.
Anesthesiology · 201d
Cleared Jan 26, 2004
NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040
K033302 · CEW
Nichols Institute Diagnostics
Chemistry · 104d
Cleared Jan 26, 2004
PREMIER IMPLANT CEMENT, MODEL 3001450
K033309 · EMA
Premier Dental Products Co.
Dental · 104d
Cleared Jan 26, 2004
VIANOX DELIVERY SYSTEM, MODEL II
K033779 · MRN
Pulmonox Medical, Inc.
Anesthesiology · 53d
Cleared Jan 23, 2004
MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS
K030598 · NLQ
Medisiss
General & Plastic Surgery · 332d
Cleared Jan 23, 2004
NEWPORT E500 WAVE VENTILATOR
K030780 · CBK
Newport Medical Instruments, Inc.
Anesthesiology · 318d
Cleared Jan 23, 2004
DUOPATH VEROTOXINS GLISA TEST
K031367 · GNA
Emd Chemicals, Inc.
Microbiology · 268d
Cleared Jan 23, 2004
PERIO PROTECT TRAY
K031809 · KMT
Perio Protect, LLC
Dental · 225d