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
122281–122304 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 1991
STERILE SURGEON'S GLOVES
K902449 · KGO
Unigloves , Ltd.
General Hospital · 284d
Cleared Mar 12, 1991
ADVANCED ISCHEMICA RECORDERS MODEL 2000 CASSETTE
K902766 · DSH
Advanced Ischemia Recorders, Inc.
Cardiovascular · 264d
Cleared Mar 12, 1991
RETAINER, SCREW EXPANSION ORTHODONTIC
K903498 · EJF
Masel Industries, Inc.
Dental · 221d
Cleared Mar 12, 1991
BACT/ALERT (TM)
K903505 · MDB
Organon Teknika Corp.
Microbiology · 221d
Cleared Mar 12, 1991
CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY
K904329 · MCB
Baxter Healthcare Corp
Microbiology · 173d
Cleared Mar 12, 1991
SPIROLOOP, MODIFICATION
K904633 · CCJ
Pneumedics, Inc.
Anesthesiology · 168d
Cleared Mar 12, 1991
SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION
K905179 · LJC
Syva Co.
Microbiology · 113d
Cleared Mar 12, 1991
NEXT WAVE(R) PHYSIOACCOUSTIC(TM) CHAIR
K905256 · IOR
Next Wave, Inc.
Physical Medicine · 111d
Cleared Mar 12, 1991
EDLICH WOUND MANAGEMENT TRAY
K905572 · MCY
Sorex Medical
General & Plastic Surgery · 90d
Cleared Mar 12, 1991
EXACTECH HUMERAL SHOULDER PROSTHESIS
K905577 · HSD
Exactech, Inc.
Orthopedic · 90d
Cleared Mar 12, 1991
TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO
K905580 · HSD
Exactech, Inc.
Orthopedic · 90d
Cleared Mar 12, 1991
EXTERNAL FETAL MONITOR TRANSDUCER HOLDER
K905606 · HGM
Atheus Corp.
Obstetrics & Gynecology · 88d
Cleared Mar 12, 1991
KODAK X-OMAT MULTILOADER 300
K905607 · IXW
Eastman Kodak Company
Radiology · 88d
Cleared Mar 12, 1991
SEMINOR
K905764 · MFD
Promedex, Inc.
Obstetrics & Gynecology · 75d
Cleared Mar 12, 1991
CIBA CORNING ACS FERRITIN IMMUNOASSAY
K905770 · DBF
Ciba Corning Diagnostics Corp.
Immunology · 75d
Cleared Mar 12, 1991
Q SYSTEM 28 HIP STEM
K910010 · LWJ
Turnkey Intergration USA, Inc.
Orthopedic · 69d
Cleared Mar 12, 1991
POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK
K910082 · DGC
Quidel Corp.
Immunology · 63d
Cleared Mar 12, 1991
TVS II ELECTRONIC INCENTIVE SPIROMETER
K910138 · BWF
Monaghan Medical Corp.
Anesthesiology · 57d
Cleared Mar 12, 1991
SUNGLASSES
K910329 · HOI
Cutler & Gross Sloan Optical , Ltd.
Ophthalmic · 46d
Cleared Mar 12, 1991
BIODEGRADABLE SURGICAL STAPLE
K910723 · JDR
Instrument Makar, Inc.
Orthopedic · 20d
Cleared Mar 11, 1991
CHEMA CHOL CHOLESTEROL SYSTEM
K904031 · CHH
Texas Intl. Laboratories, Inc.
Chemistry · 192d
Cleared Mar 11, 1991
GLUCOSE (HK) REAGENT, UNIVERSAL
K905227 · CFR
Enzyme Technology, Inc.
Chemistry · 111d
Cleared Mar 11, 1991
ANTIGENZ CHLAMYDIA
K905402 · GZB
Northumbria Biologicals , Ltd.
Microbiology · 98d
Cleared Mar 11, 1991
WOVEN AND KNITTED MINICRIMP CAROTID PATCH FABRICS
K905496 · DXZ
Meadox Medicals, Div. Boston...
Cardiovascular · 94d