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
143257–143280 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 1986
MINI-HOLTER, MODEL 2000
K862526 · DSH
Holter Recorders
Cardiovascular · 54d
Cleared Aug 25, 1986
MODEL SC-1000 ELECTROCARDIOGRAPH SPECIFICATION
K862748 · DPS
Cambridge Medical Instruments, Inc.
Cardiovascular · 35d
Cleared Aug 25, 1986
SARA RT
K862880 · CCK
Alleghany Intl. Medical Technology
Anesthesiology · 26d
Cleared Aug 25, 1986
CLASSIC RESTING SILVER-SILVERCHLORIDE ELECTRODE
K862953 · DRY
Classic Medical Products, Inc.
Cardiovascular · 20d
Cleared Aug 25, 1986
MICRA MICROSURGICAL INSTRUMENTS
K862971 · GZX
Cordis Corp.
Neurology · 19d
Cleared Aug 21, 1986
KEELER DUAL LIGHTSOURCE
K861746 · HPQ
Keeler Instruments, Inc.
Ophthalmic · 107d
Cleared Aug 21, 1986
KEELER FIBEROPTIC HEADLAMP
K861747 · HPQ
Keeler Instruments, Inc.
Ophthalmic · 107d
Cleared Aug 21, 1986
FORMOSTAR
K862106 · IRT
Lmv, Liske & Methling, GmbH
Physical Medicine · 80d
Cleared Aug 21, 1986
IRRIGATION & ASPIRATION/VITRECTOMY DEVICE
K862188 · HQE
Coburn Optical Ind., Inc.
Ophthalmic · 73d
Cleared Aug 21, 1986
PRESSURE CONTROL VALVE & TUBING CAT. NO. 83-1010
K862213
Lifestream Int'L, Inc.
General & Plastic Surgery · 72d
Cleared Aug 21, 1986
CELLMATICS RSV DETECTION SYSTEM
K862321 · LKT
Difco Laboratories, Inc.
Microbiology · 64d
Cleared Aug 21, 1986
CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM
K862323 · HKI
Canon USA, Inc.
Ophthalmic · 63d
Cleared Aug 21, 1986
U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK)
K862641 · KHG
U. S. Diagnostics, Inc.
Hematology · 41d
Cleared Aug 21, 1986
KARICKHOFF DIAGNOSTIC/LASER LENS
K862692 · HKS
Ocular Instruments, Inc.
Ophthalmic · 37d
Cleared Aug 21, 1986
ABRAHAM IRIDECTOMY LENS (YAG LASER)
K862713 · HKS
Ocular Instruments, Inc.
Ophthalmic · 36d
Cleared Aug 21, 1986
SOLARSHIELDS
K862719 · HQY
Dioptics
Ophthalmic · 35d
Cleared Aug 21, 1986
HOSKINS NYLON SUTURE LASER LENS
K862728 · HJK
Ocular Instruments, Inc.
Ophthalmic · 34d
Cleared Aug 21, 1986
INTERVASCULAR OCHSNER MICRON VASCULAR PROSTHESES
K862739 · DSY
Intervascular, Inc.
Cardiovascular · 31d
Cleared Aug 21, 1986
CBC-CAL (TM) PLUS/MULTIPLE
K862858 · KRX
R&D Systems, Inc.
Hematology · 23d
Cleared Aug 21, 1986
ABRAHAM YAG LASER LENS
K862868 · HJK
Ocular Instruments, Inc.
Ophthalmic · 23d
Cleared Aug 21, 1986
PETRUS SINGLE MIRROR LASER LENS
K862869 · LQJ
Ocular Instruments, Inc.
Ophthalmic · 23d
Cleared Aug 21, 1986
SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE
K862943 · HQE
Site Microsurgical Systems, Inc.
Ophthalmic · 16d
Cleared Aug 21, 1986
MERIVAARA GERIATRIC CHAIR MODEL 455
K862957 · INN
Global Medical Prods, Inc.
Physical Medicine · 15d
Cleared Aug 21, 1986
SURGICAL DRILL (ELECTRIC) INCLUDING HANDPIECE
K862989 · HBC
Entronics
Neurology · 13d