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
167425–167448 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 1980
VASPAR SEALANT
K792702 · KEQ
Meridian Diagnostics, Inc.
Pathology · 28d
Cleared Jan 24, 1980
LACTO-PHENOL ANALINE BLUE FLUID
K792703 · KEQ
Meridian Diagnostics, Inc.
Radiology · 28d
Cleared Jan 24, 1980
PARA-PAK(WHEATLEY'S TRICHROME STAIN)
K792706 · HYW
Meridian Diagnostics, Inc.
Pathology · 28d
Cleared Jan 24, 1980
KOH MOUNTING FLUID W/GLYCEROL
K792709 · KEQ
Meridian Diagnostics, Inc.
Pathology · 28d
Cleared Jan 24, 1980
PARA-PAK PVA
K792714 · IFQ
Meridian Diagnostics, Inc.
Pathology · 28d
Cleared Jan 24, 1980
CANDIDA ALBICANS, ANTIGEN
K792716 · GMI
Meridian Diagnostics, Inc.
Microbiology · 28d
Cleared Jan 24, 1980
NOVAMETRIX CPAP NASAL CANNULA
K792722 · BZD
Novametrix Medical Systems, Inc.
Anesthesiology · 24d
Cleared Jan 24, 1980
ANITOMIC TOTAL HIP SYSTEM
K800050 · JDG
Hexcel Medical
Orthopedic · 15d
Cleared Jan 24, 1980
VENTILATOR SET
K800056 · BTT
Abbott Laboratories
Anesthesiology · 14d
Cleared Jan 24, 1980
NEBULIZER TUBING SET
K800083 · CAF
Abbott Laboratories
Anesthesiology · 10d
Cleared Jan 24, 1980
VENTILATOR TEST LUNG
K800125 · CBK
Bio-Med Devices, Inc.
Anesthesiology · 6d
Cleared Jan 23, 1980
FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD
K792249 · GOL
Intl. Diagnostic Technology
Microbiology · 77d
Cleared Jan 23, 1980
CUTTER POINTS
K792250 · EHL
Cutter Laboratories, Inc.
Dental · 76d
Cleared Jan 23, 1980
BIOPHASE IMPLANT MATERIAL
K792329 · JDG
Richard'S Medical Equip., Inc.
Orthopedic · 65d
Cleared Jan 23, 1980
WIDEX HEARING AID MODEL S10
K792389 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 58d
Cleared Jan 23, 1980
COE-SIL
K792428 · LDG
Coe Laboratories, Inc.
Ear, Nose, Throat · 57d
Cleared Jan 23, 1980
CARDIASSIST EXTERNAL COUNTERPULSATION
K792430 · DRN
Cardiassist Corp.
Cardiovascular · 57d
Cleared Jan 23, 1980
INTERSCI TEST FOR ALCOHOL IN BODY FLUIDS
K792469 · DOJ
Intersci Corp.
Toxicology · 51d
Cleared Jan 23, 1980
WIDEX HEARING AID MODEL 820
K792567 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 58d
Cleared Jan 23, 1980
HEARING AID, MODELS DRI-35/DL1-35
K792643 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 28d
Cleared Jan 23, 1980
TELESONIC V-101
K792644 · ESD
Telesonic, Inc.
Ear, Nose, Throat · 28d
Cleared Jan 23, 1980
BLASTOMYCES/ANTIGEN FOR IMMUNODIFUSION
K792683 · JWW
Meridian Diagnostics, Inc.
Microbiology · 27d
Cleared Jan 23, 1980
HISTOPLASMA CAPSULATUM, ANTIGEN
K792701 · GMJ
Meridian Diagnostics, Inc.
Microbiology · 27d
Cleared Jan 23, 1980
CANDIDA ALBICANS, ANTISERUM
K792713 · GMI
Meridian Diagnostics, Inc.
Microbiology · 27d