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
142009–142032 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 1986
USI AUTOJECT INSULIN SYRINGE
K864761 · FMF
Ulster Scientific, Inc.
General Hospital · 11d
Cleared Dec 15, 1986
FISCHER PPS/MAMMOTEST MAMMOGRAPHY SYSTEM
K861692 · IZH
Fischer Imaging Corp.
Radiology · 227d
Cleared Dec 15, 1986
ARTHROSCOPIC SHOULDER LIGAMENT REPAIR KIT
K862017 · HRX
Dyonics, Inc.
Orthopedic · 201d
Cleared Dec 15, 1986
MULTISPIRO SA/100
K863134 · BZG
Biotrine Corp.
Anesthesiology · 122d
Cleared Dec 15, 1986
NO-FLO I
K863613 · CCN
Design Technologies, Inc.
Anesthesiology · 90d
Cleared Dec 15, 1986
BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT
K863743 · DHB
Immuno Nuclear Corp.
Immunology · 82d
Cleared Dec 15, 1986
BIRD NIGHTBIRD NASAL CPAP SYSTEM
K863746 · BZD
Bird Products Corp.
Anesthesiology · 82d
Cleared Dec 15, 1986
VIS-CUBE HCG (EIA)
K863933 · JHI
Leeco Diagnostics, Inc.
Chemistry · 68d
Cleared Dec 15, 1986
PORTABLE LIQUID OXYGEN UNIT (MODIFICATION)
K863978 · BYJ
Penox Technologies, Inc.
Anesthesiology · 62d
Cleared Dec 15, 1986
OPEN RESERVOIR SCAVENGER
K864034 · CBN
Draeger Medical, Inc.
Anesthesiology · 61d
Cleared Dec 15, 1986
VES-10 INTRAOCULAR SCISSORS DRIVE
K864035 · HQE
Trek Medical Products, Inc.
Ophthalmic · 60d
Cleared Dec 15, 1986
ESOPHAGEAL STETHOSCOPE W/THERMOCOUPLE TYPE T
K864043 · BZT
Respiratory Support Products, Inc.
Anesthesiology · 60d
Cleared Dec 15, 1986
BKS-42 DISPOSABLE VACUUM TUBING PACK
K864065 · HNO
Allergan, Inc.
Ophthalmic · 56d
Cleared Dec 15, 1986
ANTI-NDNA ANTIBODY TEST KIT
K864275 · KTL
Cappel Diagnostics, Inc.
Immunology · 47d
Cleared Dec 15, 1986
RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE
K864290 · HNN
Keeler Instruments, Inc.
Ophthalmic · 45d
Cleared Dec 15, 1986
SITE PHACOEMULSIFICATION SYST/OPHTHALMIC USE (MOD)
K864301 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 45d
Cleared Dec 15, 1986
YANNUZZI FUNDUS LASER LENS
K864304 · HJK
Ocular Instruments, Inc.
Ophthalmic · 45d
Cleared Dec 15, 1986
PORTA RAY MODEL 325
K864339 · IZO
Porta Ray, Inc.
Radiology · 41d
Cleared Dec 15, 1986
LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER
K864369 · HJB
Heidelberg Instruments
Ophthalmic · 40d
Cleared Dec 15, 1986
EMERSON 3MV VOLUME VENTILATOR
K864379 · CBK
J. H. Emerson Co.
Anesthesiology · 40d
Cleared Dec 15, 1986
HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN
K864467 · HOO
Keeler Instruments, Inc.
Ophthalmic · 33d
Cleared Dec 15, 1986
LEG HOLDER
K864476 · HRX
American Container Technology, Inc.
Orthopedic · 32d
Cleared Dec 15, 1986
MODEL 6500 OPTHALMIC CHAIR
K864494 · HME
Koken Mfg Company, Inc.
Ophthalmic · 31d
Cleared Dec 15, 1986
MAC 150E OPTHALMIC CHAIR
K864574 · HME
Koken Mfg Company, Inc.
Ophthalmic · 25d