FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
152953–152976 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 24, 1984
TRANSCUTANEOUS 800-OXYGEN MONITORS/801
K840993 · KLK
Novametrix Medical Systems, Inc.
Anesthesiology · 47d
Cleared Apr 24, 1984
SURGICAL INSTRUMENT DEMAGNETIZER
K841086
Scanlan Intl., Inc.
General & Plastic Surgery · 42d
Cleared Apr 24, 1984
VASCULAR-ACCESS PORT - ENLARGEMENT
K841149 · LJT
Norfolk Medical Products, Inc.
General Hospital · 109d
Cleared Apr 24, 1984
VASCULAR-ACCESS PORT CHANGE CATHETER
K841150 · LJT
Norfolk Medical Products, Inc.
General Hospital · 47d
Cleared Apr 24, 1984
OMNISTIM III INTERFERENTIAL THERAPY
K841278 · IPF
Physio Technology, Inc.
Physical Medicine · 27d
Cleared Apr 24, 1984
DISPOSABLE SUCTION TUBING SET
K841283
Aesthetech Corp.
General & Plastic Surgery · 27d