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
146329–146352 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 1985
AMERICAN STERILE MAYO STAND TRAY
K854759
American Hospital Supply Corp.
General & Plastic Surgery · 20d
Cleared Dec 16, 1985
SPINAL STABILIZING UNIT
K851864
Counterstress Products, Inc.
Orthopedic · 234d
Cleared Dec 16, 1985
LINK SHOULDER PROSTHESIS ENDO-MODEL SYSTEM
K852365 · KWS
Link America, Inc.
Orthopedic · 195d
Cleared Dec 16, 1985
STORZ IAS DISPOSABLE PACK
K853430 · HQE
Storz Instrument Co.
Ophthalmic · 123d
Cleared Dec 16, 1985
BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT
K853697 · DAK
Biostar Medical Products, Inc.
Immunology · 103d
Cleared Dec 16, 1985
ALL-IN-ONE HARD CONTACT LENS SOLUTION
K853807 · HPX
Maurry Biological Co.
Ophthalmic · 96d
Cleared Dec 16, 1985
WETTING SOLUTION FOR HARD CONTACT LENSES
K853810 · HPX
Maurry Biological Co.
Ophthalmic · 96d
Cleared Dec 16, 1985
HARD CONTACT LENS SOAKING SOLUTION
K853811 · HPX
Maurry Biological Co.
Ophthalmic · 96d
Cleared Dec 16, 1985
MEMBRANE OXYGENATING SYS ADULT BMOS-7 & BMOS-3 PED
K854045 · DTZ
American Bentley
Cardiovascular · 75d
Cleared Dec 16, 1985
PUPILSCAN
K854169
Fairville Medical Optics, Inc.
Ophthalmic · 62d
Cleared Dec 16, 1985
ROOT CANAL FILLING RESIN
K854253 · KIF
Dentsply Intl.
Dental · 55d
Cleared Dec 16, 1985
FANA 60
K854314 · DHN
American Bio-Reagents, Inc.
Immunology · 49d
Cleared Dec 16, 1985
HD-SECURA HEMADIALYSIS MACHINE
K854367 · FKP
Organon Teknika Corp.
Gastroenterology & Urology · 48d
Cleared Dec 16, 1985
MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50
K854440 · HRM
Keeler Instruments, Inc.
General & Plastic Surgery · 41d
Cleared Dec 16, 1985
BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH
K854479 · FKP
Nipro Company, Ltd.
Gastroenterology & Urology · 39d
Cleared Dec 13, 1985
PORTASPIR II
K851560 · BTA
Roseburg SA
General & Plastic Surgery · 241d
Cleared Dec 13, 1985
HESSBURG LIGHT GUARD
K853035 · HOY
Visitec Co.
Ophthalmic · 148d
Cleared Dec 13, 1985
700-123 EYE SHADE
K853043 · HQY
Health Saver Products
Ophthalmic · 147d
Cleared Dec 13, 1985
KESTREL CONTACT LENS STORAGE CASE(NORYL)
K853728 · HPX
Ryder Intl. Corp.
Ophthalmic · 98d
Cleared Dec 13, 1985
KESTREL CONTACT LENS STORAGE CASE(POLYSTYRENE)
K853729 · HPX
Ryder Intl. Corp.
Ophthalmic · 98d
Cleared Dec 13, 1985
THE GRONINGEN VOICE PROSTHESIS
K853940 · EWL
Hood Laboratories
Ear, Nose, Throat · 80d
Cleared Dec 13, 1985
VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100
K853961 · HQE
Visitec Co.
Ophthalmic · 79d
Cleared Dec 13, 1985
IN-HOME VISION MONITORING KIT
K854047 · HOX
Rich-Larky Company, Inc.
Ophthalmic · 71d
Cleared Dec 13, 1985
RESNICK EMITTER, ARTIFICIAL LARYNX
K854158 · ESE
Dynamed Audio, Inc.
Ear, Nose, Throat · 63d