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
141889–141912 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 29, 1986
HERCON ANTISEPTIC TRANSPARENT DRESSING
K864076 · KGX
Hercon Laboratories Corp.
General & Plastic Surgery · 70d
Cleared Dec 29, 1986
MINIMED MODEL 404-S EXTERNAL INFUSION PUMP
K864138 · FRN
Medtronic Minimed
General Hospital · 69d
Cleared Dec 29, 1986
NEOPROBE PORTABLE RADIOISOTOPE DETECTOR
K864263 · IZD
Neoprobe Corp.
Radiology · 61d
Cleared Dec 29, 1986
TRICOTEX WOUND CONTACT LAYER DRESSING
K864264 · NAB
Smith & Nephew, Inc.
General & Plastic Surgery · 61d
Cleared Dec 29, 1986
MUSCLE MASTER (MEDIUM VOLTAGE STIMULATOR)
K864284 · IPF
Modern Systems Technology, Inc.
Physical Medicine · 60d
Cleared Dec 29, 1986
DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY
K864292 · HNQ
Eye-Ko, Inc.
Ophthalmic · 59d
Cleared Dec 29, 1986
U66 EMS
K864558 · IPF
Suntec Health & Fitness Group, Inc.
Physical Medicine · 59d
Cleared Dec 29, 1986
FLUOROVISION CONTRAST ENHANCER
K864584 · JAA
Digivision, Inc.
Radiology · 39d
Cleared Dec 29, 1986
MYOPAC (TM), MODEL 9600
K864625 · IPF
Medical Devices, Inc.
Physical Medicine · 34d
Cleared Dec 29, 1986
KC/EMG DIAGNOSTIC ELECTROMYOGRAPH
K864630 · IKN
Chattanooga Group, Inc.
Neurology · 34d
Cleared Dec 29, 1986
REUSABLE SURGICAL KERATOSCOPE
K864639 · HLR
Jedmed Instrument Co.
Ophthalmic · 33d
Cleared Dec 29, 1986
MODEL 2060 W/6 CM(2) & MODEL 2100 W/10 CM(2) TRANS
K864653 · IMJ
Rich-Mar Corp.
Physical Medicine · 31d
Cleared Dec 29, 1986
HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM
K864676 · JXG
American V. Mueller
Neurology · 27d
Cleared Dec 29, 1986
VARIOUS SYRINGES W/NEEDLES, W/OUT NEEDLES, NEEDLES
K864747 · FMF
Jms Co., Ltd.
General Hospital · 24d
Cleared Dec 29, 1986
CULTURIA MACCONKEY-MUG/CLED SYSTEMS
K864764 · JSI
Clinical Convenience Products, Inc.
Microbiology · 24d
Cleared Dec 29, 1986
MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 3ML/CC
K864777 · FMF
Mac Lee Medical Products
General Hospital · 21d
Cleared Dec 29, 1986
MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CC
K864778 · FMF
Mac Lee Medical Products
General Hospital · 21d
Cleared Dec 29, 1986
MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC
K864779 · FMF
Mac Lee Medical Products
General Hospital · 21d
Cleared Dec 29, 1986
MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 20ML/CC
K864781 · FMF
Mac Lee Medical Products
General Hospital · 21d
Cleared Dec 29, 1986
EXACTECH TOTAL HIP INSTRUMENTS
K864788
Exactech, Inc.
Orthopedic · 21d
Cleared Dec 29, 1986
COLLINS POSITIONING DEVICE
K864880 · FWZ
Orthopedic Systems, Inc.
General & Plastic Surgery · 17d
Cleared Dec 29, 1986
ARTHROSCOPIC ANKLE HOLDER
K864881 · FWZ
Orthopedic Systems, Inc.
General & Plastic Surgery · 17d
Cleared Dec 24, 1986
FASCICULATED I ROD
K863215
The Deca Co.
Orthopedic · 126d
Cleared Dec 24, 1986
FASCICULATED BOAT ROD
K863239
The Deca Co.
Orthopedic · 124d