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
58129–58152 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 15, 2007
EARLYSENSE ES-16 SYSTEM
K070375 · BZQ
Earlysense, Ltd.
Anesthesiology · 280d
Cleared Nov 15, 2007
CHOY COMPRESSION FRAME
K070968 · LNH
Choy Medical Technologies, Inc.
Radiology · 224d
Cleared Nov 15, 2007
TRU FLU
K071657 · PSZ
Meridian Bioscience, Inc.
Microbiology · 150d
Cleared Nov 15, 2007
XPOD/XMAP NERVE STIMULATOR
K072092 · BXN
Xavant Technology (Pty), Ltd.
Anesthesiology · 108d
Cleared Nov 15, 2007
BIOXTRA MOISTURIZING GEL
K072306 · LFD
Bio-X Healthcare S.A.
Dental · 90d
Cleared Nov 15, 2007
A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE
K072593 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 62d
Cleared Nov 15, 2007
RAD VISION, MODELS E AND EU
K072659 · KPR
Almana Medical Imaging
Radiology · 56d
Cleared Nov 15, 2007
UNIDUS MAGNUM MALE LATEX CONDOM
K072747 · HIS
Unidus Corp.
Obstetrics & Gynecology · 49d
Cleared Nov 15, 2007
SPI CONTACT PLATFORM O 4.0 MM
K072933 · DZE
Thommen Medical AG
Dental · 30d
Cleared Nov 15, 2007
COLPO-MASTER
K073053 · HEX
United Products & Instruments, Inc.
Obstetrics & Gynecology · 16d
Cleared Nov 14, 2007
RESOLVE BILIARY DRAINAGE CATHETER
K063733 · FGE
Merit Medical Systems, Inc.
Gastroenterology & Urology · 331d
Cleared Nov 14, 2007
VERIFY 275 DEGREE F. 3-10 INDICATOR
K071895 · JOJ
STERIS Corporation
General Hospital · 128d
Cleared Nov 14, 2007
ODYSSEY WORKSTATION
K072371 · DXX
Stereotaxis, Inc.
Cardiovascular · 83d
Cleared Nov 14, 2007
TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER
K072549 · LJT
C.R. Bard, Inc.
General Hospital · 65d
Cleared Nov 14, 2007
ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES
K072554 · EFB
Sable Industries, Inc.
Dental · 65d
Cleared Nov 14, 2007
ANGIOJET ULTRA
K072769 · QEZ
Possis Medical, Inc.
Cardiovascular · 47d
Cleared Nov 14, 2007
SATURN 9000-550
K072984 · MQB
New Medical Co., Ltd.
Radiology · 22d
Cleared Nov 13, 2007
DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4...
K071224 · CDD
Dade Behring, Inc.
Chemistry · 195d
Cleared Nov 13, 2007
OTODYNAMICS OTOPORT
K072033 · EWO
Otodynamics, Ltd.
Ear, Nose, Throat · 112d
Cleared Nov 13, 2007
ACUSON S2000 ULTRASOUND SYSTEM
K072786 · ITX
Siemens Medical Solutions USA, Inc.
Radiology · 43d
Cleared Nov 13, 2007
SATURN 9000-750
K072983 · MQB
New Medical Co., Ltd.
Radiology · 21d
Cleared Nov 13, 2007
DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9
K073056 · MQB
Vieworks Co., Ltd.
Radiology · 14d
Cleared Nov 09, 2007
POLYGRAFT BGS
K062607 · MQV
Smith & Nephew, Inc.
Orthopedic · 430d
Cleared Nov 09, 2007
ACCESSA CHOLESTEROL PANEL
K063852 · JKA
Home Access Health Corp.
Chemistry · 316d