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
147625–147648 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 1985
STAPLE REMOVER
K853286
I M, Inc.
General & Plastic Surgery · 16d
Cleared Aug 21, 1985
CAUTERY TIP CLEANING PAD
K853315
Kleen Test Products
General & Plastic Surgery · 14d
Cleared Aug 21, 1985
JUFREY CORP. UNIVERSAL DISPOS. SCALP VEIN INFUSION
K853327 · FPA
Jufrey Multimed Corp.
General Hospital · 13d
Cleared Aug 21, 1985
NON-ADHERA ADHESIVE PAD 3X4
K853334 · NAD
American White Cross, Inc.
General & Plastic Surgery · 12d
Cleared Aug 20, 1985
CORDIS PTA CATHETER-PERCUTANEOUS CATHETER
K844913 · LIT
Cordis Corp.
Cardiovascular · 245d
Cleared Aug 20, 1985
HUNTLEIGH FLOWTRON AIR, AC400/2 AIR
K850910
Huntleigh Technology, Inc.
General & Plastic Surgery · 168d
Cleared Aug 20, 1985
HUNTLEIGH FLOWTRON AIR HAND GARMENT, HG300
K850945
Huntleigh Technology, Inc.
General & Plastic Surgery · 166d
Cleared Aug 20, 1985
GUIBOR MICROELECTROLYSIS UNIT 18
K851318 · KCW
Galvanic Medical Instruments, Inc.
General & Plastic Surgery · 140d
Cleared Aug 20, 1985
STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT
K851936 · HQE
Staar Surgical Co.
Ophthalmic · 106d
Cleared Aug 20, 1985
SITE-MALIS BIPOLAR COAGULATOR MODULE
K852075 · HQO
Valley Forge Scientific Corp.
Ophthalmic · 99d
Cleared Aug 20, 1985
MEDILASER MIC MODEL MEL 440-C
K852121 · GEX
Mochida Pharmaceutical Co., Ltd.
General & Plastic Surgery · 97d
Cleared Aug 20, 1985
MEDILASER MIC MODEL MEL-445C, 15W
K852122 · GEX
Mochida Pharmaceutical Co., Ltd.
General & Plastic Surgery · 97d
Cleared Aug 20, 1985
CERAMIC ORTHODONIT APPLIANCE
K852179 · EJF
Gac Intl., Inc.
Dental · 92d
Cleared Aug 20, 1985
PHACO-BAC STOP FILTER KIT
K852208 · HQC
Staar Surgical Co.
Ophthalmic · 91d
Cleared Aug 20, 1985
BETA QUIK STAT
K852327 · JHI
Pacific Biotech, Inc.
Chemistry · 82d
Cleared Aug 20, 1985
AURALITE II
K852403 · HQG
Aura Lens Products
Ophthalmic · 75d
Cleared Aug 20, 1985
TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST
K852751 · GMQ
Preco, Inc.
Microbiology · 53d
Cleared Aug 20, 1985
OCULAB TONOPEN
K852774 · HKY
Oculab, Inc.
Ophthalmic · 50d
Cleared Aug 20, 1985
COOPER VISION SYSTEM VI U/S MODULE
K853070 · HQC
CooperVision, Inc.
Ophthalmic · 29d
Cleared Aug 20, 1985
CUDDLE CUSHION
K853185 · LDQ
The Cuddle Co.
General & Plastic Surgery · 21d
Cleared Aug 20, 1985
INTEGRITY EYE DROP GUIDE(MODIFICATION)
K853199
Integrity Optics, Inc.
Ophthalmic · 20d
Cleared Aug 20, 1985
ASO SLIDE EIKEN
K853276 · GTQ
Syn-Kit, Inc.
Microbiology · 15d
Cleared Aug 20, 1985
EMODREN EXCHANGEABLE PLASTIC BELLOWS
K853295 · GCY
Parexel Intl. Corp.
General & Plastic Surgery · 14d
Cleared Aug 19, 1985
ECS 502
K840717 · DRT
Robert Bosch Corp.
Cardiovascular · 549d