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
70105–70128 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 2004
PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT...
K040014 · JOH
Portex , Ltd.
Anesthesiology · 51d
Cleared Feb 13, 2004
LEVIA PHOTOTHERAPY SYSTEM
K040062 · FTC
Lerner Medical Devices, Inc.
General & Plastic Surgery · 31d
Cleared Feb 13, 2004
CANNON II PLUS
K040078 · MSD
Arrow International, Inc.
Gastroenterology & Urology · 30d
Cleared Feb 13, 2004
MEDLINE STRIDER MIDI 3
K040097 · INI
Medline Industries, Inc.
Physical Medicine · 24d
Cleared Feb 13, 2004
VICEROY INFLATION DEVICE
K040138 · MAV
Merit Medical Systems, Inc.
Cardiovascular · 22d
Cleared Feb 13, 2004
BARD ATLAS PTA BALLOON DILATATION CATHETER
K040243 · DQY
C.R. Bard, Inc.
Cardiovascular · 10d
Cleared Feb 12, 2004
TITANIUM MESH SYSTEM
K032371 · MQP
Encore Medical, L.P.
Orthopedic · 195d
Cleared Feb 12, 2004
MEDLINE STRIDER, MODELS MIDI 3 AND MIDI 4
K032446 · INI
Medline Industries, Inc.
Physical Medicine · 188d
Cleared Feb 12, 2004
PRECISION SURGERY LIMITED VARIABLE AND FIXED CERVICAL PLATE SYSTEM
K032815 · KWQ
Precision Surgery Limited
Orthopedic · 156d
Cleared Feb 12, 2004
LIAISON 25 OH VITAMIN D
K032844 · MRG
DiaSorin, Inc.
Chemistry · 154d
Cleared Feb 12, 2004
ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS
K033011 · HAW
Zimmer, Inc.
Neurology · 139d
Cleared Feb 12, 2004
LEKSELL SURGIPLAN WITH IMAGEMERGE
K033340 · HAW
Elekta Instrument AB
Neurology · 118d
Cleared Feb 12, 2004
LIAISON N-TACT PTH
K033426 · CEW
DiaSorin, Inc.
Chemistry · 108d
Cleared Feb 12, 2004
MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE
K033718 · GAT
Arthrotek, Inc.
General & Plastic Surgery · 78d
Cleared Feb 12, 2004
SIREMOBILE C06
K040066 · OXO
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Feb 12, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K040072 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Feb 12, 2004
VASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT RADIAL...
K040118 · QSX
Vascular Solutions, Inc.
General & Plastic Surgery · 23d
Cleared Feb 12, 2004
IQ GUIDE WIRE
K040140 · DQX
Boston Scientific Corp
Cardiovascular · 21d
Cleared Feb 11, 2004
WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254
K023889 · MIU
Wiener Laboratories Saic
Microbiology · 447d
Cleared Feb 11, 2004
OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XL
K032305 · DXN
Omron Healthcare, Inc.
Cardiovascular · 201d
Cleared Feb 11, 2004
TRIO MONITOR MODEL 0998-00-0600
K032338 · MWI
Datascope Corp.
Cardiovascular · 197d
Cleared Feb 11, 2004
SYSMEX POCH-100I
K032677 · GKL
Sysmex America, Inc.
Hematology · 166d
Cleared Feb 11, 2004
LINVATEC 10K IRRIGATION SYSTEM
K033573 · HRX
Linvatec Corp.
Orthopedic · 90d
Cleared Feb 11, 2004
BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER
K040034 · MNI
Blackstone Medical, Inc.
Orthopedic · 34d