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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
153793–153816 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 1984
TOXOPLASMA GOND II IGG DIA TEST KIT
K833829 · LGD
Labsystems, Inc.
Microbiology · 173d
Cleared Apr 24, 1984
VAS-CATH DSA CATHETER/TRAY
K834232 · DQY
Vas-Cath of Canada , Ltd.
Cardiovascular · 140d
Cleared Apr 24, 1984
POSIDYNE I.V. FILTER/AIR ELIMINATOR
K834381 · FPB
Pall Biomedical Products Co.
General Hospital · 133d
Cleared Apr 24, 1984
LUMELEC ELECTRODE CATHETER
K834416 · LDF
Cordis Corp.
Cardiovascular · 131d
Cleared Apr 24, 1984
PTCA BALLOON CATHETERS & ACCESS.
K834433
Advanced Cardiovascular Systems, Inc.
General & Plastic Surgery · 139d
Cleared Apr 24, 1984
SHEATHS FOR REINFORCING BONE CEMENT
K834499
Mecron Medical Products, Inc.
General & Plastic Surgery · 126d
Cleared Apr 24, 1984
PETRUS IOL GUIDE
K840104 · KYB
Precision-Cosmet Co., Inc.
Ophthalmic · 105d
Cleared Apr 24, 1984
TANSEEKER
K840132 · FTC
Senator Leisure Products, Ltd.
General & Plastic Surgery · 109d
Cleared Apr 24, 1984
ULTRAVIOLET TANNING SYSTEMS
K840133 · FTC
Merrittan Sunfun, Inc.
General & Plastic Surgery · 111d
Cleared Apr 24, 1984
KOSMEDICO GMBH SUNLAMP PRODUCTS
K840158 · FTC
Kosmedico, Kosmetische & Medizinisch
Radiology · 102d
Cleared Apr 24, 1984
HEMOFILTRATION CATHETER HF-100
K840322 · FIQ
Vas-Cath of Canada , Ltd.
Gastroenterology & Urology · 90d
Cleared Apr 24, 1984
FLEXIBLE ILLUMINATOR 5
K840371 · FTF
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery · 88d
Cleared Apr 24, 1984
FLEXIBLE ILLUMINATOR 15
K840372 · FTF
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery · 88d
Cleared Apr 24, 1984
FLEXIBLE ILLUMINATOR 10
K840373 · FTF
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery · 88d
Cleared Apr 24, 1984
SCIMED MODEL SC4000
K840610 · DTP
Scimed Life Systems, Inc.
Cardiovascular · 71d
Cleared Apr 24, 1984
FIBER HEMOFILTERS FH55-FH77 & 88
K840720 · KOJ
Gambro, Inc.
Dental · 67d
Cleared Apr 24, 1984
HEARING AIDS IN-THE-EAR
K840728 · ESD
Hearing Instruments, Inc.
Ear, Nose, Throat · 63d
Cleared Apr 24, 1984
VASCULAR ACCESS PORT CHANGES IN MATER
K840788 · LJT
Norfolk Medical Products, Inc.
General Hospital · 109d
Cleared Apr 24, 1984
MALE-MALE LUER LOCK CONNECTOR W/ROTA
K840797 · DTL
American Pharmaseal Div. Ahsc
Cardiovascular · 61d
Cleared Apr 24, 1984
FR MEDICAL X-RAY FILM
K840806 · IWZ
Fr Medical/Fr Chemicals
Radiology · 60d
Cleared Apr 24, 1984
ELECTRICAL NEURO-MUSCULAR STIMULATOR
K840895 · IPF
Richards Medical Co., Inc.
Physical Medicine · 57d
Cleared Apr 24, 1984
PROVAC WOUND DRAINAGE & HEALING SYS
K840913 · GCY
Meyer Medical U.S.A., Inc.
General & Plastic Surgery · 55d
Cleared Apr 24, 1984
INTRADISCAL THERAPY NEEDLE 18 GAUGE
K840922 · GAA
Dlp, Inc.
General & Plastic Surgery · 53d
Cleared Apr 24, 1984
EMIT QST PRIMIDONE ASSAY
K840939 · DJD
Syva Co.
Toxicology · 50d