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
148801–148824 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 12, 1985
DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO
K850574 · JJY
American Dade
Immunology · 58d
Cleared Apr 12, 1985
TOTAL HIGE ENZYME IMMUNOASSAY
K850786 · DGC
Nms Pharmaceuticals, Inc.
Immunology · 45d
Cleared Apr 12, 1985
TACTILE PLUS DENTAL ELEVATORS
K850906 · EMJ
Ipco Corp.
Dental · 38d
Cleared Apr 12, 1985
MEDIX VISUAL URINE HCG (7/7) TEST
K850949 · JHI
Medix Biotech, Inc.
Chemistry · 36d
Cleared Apr 12, 1985
HFF GENCELLS
K850990 · KIT
Bioassay Systems Research Corp.
Hematology · 32d
Cleared Apr 12, 1985
EMIT QST PROCAINAMIDE ASSAY
K851061 · LAR
Syva Co.
Toxicology · 28d
Cleared Apr 12, 1985
PHARMACIA INSULIN RIA
K851071 · CFP
Pharmacia, Inc.
Chemistry · 25d
Cleared Apr 12, 1985
MONOJECT STERILE 12CC SYRINGES, W/WO NEEDLES
K851089 · FMF
Sherwood Medical Co.
General Hospital · 25d
Cleared Apr 12, 1985
MONOJECT STERILE 1/2 CC & 1CC SYRINGES W & W/O NEE
K851090 · FMF
Sherwood Medical Co.
General Hospital · 25d
Cleared Apr 12, 1985
BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SET
K851101 · FOZ
Bionomy, Inc.
General Hospital · 24d
Cleared Apr 12, 1985
PACKETS FOR PREP. OF DIALYSATES & INFUSATES -
K851188 · FKT
Organon Teknika Corp.
Gastroenterology & Urology · 43d
Cleared Apr 12, 1985
PLAYTEX SUPER PLUS TAMPONS & DEODORANT TAMPONS
K851355 · HEB
Intl. Playtex, Inc.
Obstetrics & Gynecology · 8d
Cleared Apr 12, 1985
PLAYTEX SUPER TAMPONS & SUPER DEODORANT TAMPONS
K851356 · HEB
Intl. Playtex, Inc.
Obstetrics & Gynecology · 8d
Cleared Apr 12, 1985
HEALTHCHECK DIGITAL THERMOMETER MODEL 1 TH-2
K851379 · FLL
Healthcheck Corp.
General Hospital · 4d