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

Filters: Cleared only ×
175,820 results
149377–149400 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 1985
TRIAD C & B MATERIAL
K850911 · EBF
Dentsply Intl.
Dental · 42d
Cleared Apr 16, 1985
WAX BITE IMPRESSION WAFER
K850915 · EGD
Toothprints, Inc.
Dental · 42d
Cleared Apr 16, 1985
BOVO MOISTURE GUARD
K850988 · KHR
E.H. Medical Co.
Dental · 36d
Cleared Apr 16, 1985
MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR
K851091 · JOQ
Medtronic Vascular
Cardiovascular · 29d
Cleared Apr 15, 1985
HENNING MENISCAL SUTURE KIT
K843942 · LXH
Stryker Corp.
Orthopedic · 188d
Cleared Apr 15, 1985
PROFESSIONAL SUPPLIES, INC.LENS CARRYING CASE
K850046 · HPX
Professional Supplies, Inc.
Ophthalmic · 98d
Cleared Apr 15, 1985
WOUND DRESSING MODEL ZB-6
K850076 · NAD
Thermedics, Inc.
General & Plastic Surgery · 96d
Cleared Apr 15, 1985
KCP PAK CONVENIENCE PACK
K850148 · HQC
CooperVision, Inc.
Ophthalmic · 91d
Cleared Apr 15, 1985
KCP (KELMAN COMPACT PHACO-EMULSIFIER) PEA
K850149 · HQC
CooperVision, Inc.
Ophthalmic · 91d
Cleared Apr 15, 1985
SPARCO SCOPE GUARD
K850268 · FEB
Sparco, Inc.
General Hospital · 82d
Cleared Apr 15, 1985
KCP PAK #2 CONVENIENCE PACK MODIFICATION
K850275 · HQC
CooperVision, Inc.
Ophthalmic · 82d
Cleared Apr 15, 1985
PLUS 1
K850478 · IYO
Dymax Corp
Radiology · 63d
Cleared Apr 15, 1985
ATLANTIC OPTICAL SYSTEMS, INC. UNIVERSAL PACK
K850532 · HQC
Atlantic Optical Systems, Inc.
Ophthalmic · 63d
Cleared Apr 15, 1985
AMNIGLOVE & AMNICOT
K850758 · HGE
Go Medical Industries Pty. , Ltd.
Obstetrics & Gynecology · 49d
Cleared Apr 15, 1985
VAN-TEC MEATAL DILATOR
K851158 · KOE
Van-Tec, Inc.
Gastroenterology & Urology · 24d
Cleared Apr 15, 1985
AL ASKARI PERCUTANEOUS ACCESS NEEDLE HOLDER
K851162 · KOA
Van-Tec, Inc.
Gastroenterology & Urology · 24d
Cleared Apr 15, 1985
AMBU CPAP SYSTEM
K851194 · BYE
Ambu, Inc.
Anesthesiology · 20d
Cleared Apr 12, 1985
CURING LIGHT
K843049
Penn-Med Technology, Inc.
Dental · 252d
Cleared Apr 12, 1985
MAST ALLERGY SYSTEM
K843694 · DHB
Mast Immunosystems
Immunology · 205d
Cleared Apr 12, 1985
MAST LUMINESCENT ALLERGY SYSTEM
K844629 · DHB
Mast Immunosystems
Immunology · 136d
Cleared Apr 12, 1985
VIGGO NEOFLON INFUSION CANNULA
K850276 · FOZ
Viggo Products
General Hospital · 79d
Cleared Apr 12, 1985
VIGGO I.V. ACCESSORIES-VIGGO EXTENSION TUBES ETC.
K850277 · FPA
Viggo Products
General Hospital · 79d
Cleared Apr 12, 1985
LASER RF TEST -RHEUMATOID FACTOR(S) REAGENTS
K850296 · DHR
Behring Diagnostics, Inc.
Immunology · 78d
Cleared Apr 12, 1985
INTELLIGENT PHOTOMETERS MCP, IFP, ISP, FPS, SPS
K850392 · JJQ
Clinical Data, Inc.
Chemistry · 70d