FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
94993–95016 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 1997
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
K964770 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 86d
Cleared Feb 21, 1997
DENTEMP ONE STEP
K964773 · EMA
Majestic Drug Co., Inc.
Dental · 86d
Cleared Feb 21, 1997
CPI MODEL 6240 50 PSI NEBULIZER COMPRESSOR
K964994 · CAF
Contemporary Products, Inc.
Anesthesiology · 67d
Cleared Feb 21, 1997
SPYGLASS ANGIOGRAPHIC CATHETER
K965249 · DQO
Daig Corp.
Cardiovascular · 71d
Cleared Feb 20, 1997
HEMAGEN CMV IGG KIT
K944438 · LFZ
Hemagen Diagnostics, Inc.
Microbiology · 892d
Cleared Feb 20, 1997
ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
K962475 · CAC
Transfusion Technologies Corp.
Anesthesiology · 240d
Cleared Feb 20, 1997
MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV
K962517 · MNS
Healthdyne Technologies, Inc.
Anesthesiology · 238d
Cleared Feb 20, 1997
MAXI LD PTA BALLOON CATHETER
K963000 · LIT
Cordis Corp.
Cardiovascular · 202d
Cleared Feb 20, 1997
QUICKPAC II ONE STEP MARIJUANA (THC) TEST
K963207 · LDJ
Drial Consultants, Inc.
Toxicology · 189d
Cleared Feb 20, 1997
SUPREME II METER
K963544 · CGA
Chronimed, Inc.
Chemistry · 169d
Cleared Feb 20, 1997
PRECISION G BLOOD GLUCOSE TESTING SYSTEM
K963676 · CGA
Medisense, Inc.
Chemistry · 160d
Cleared Feb 20, 1997
FLEXIBLE CYSTOSCOPE
K964037 · FAJ
Applied Fiberoptics, Inc.
Gastroenterology & Urology · 135d
Cleared Feb 20, 1997
GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)
K964061 · LYK
W.L. Gore & Associates, Inc.
Cardiovascular · 133d
Cleared Feb 20, 1997
HEMATACHEK
K964452 · GLK
Richmond Diagnostics, Inc.
Hematology · 106d
Cleared Feb 20, 1997
ACCUPACK PREGNANCY TEST
K964633 · JHI
Genix Biotek, Inc.
Chemistry · 93d
Cleared Feb 20, 1997
SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS
K964696 · LPL
Sunsoft Corp.
Ophthalmic · 90d
Cleared Feb 20, 1997
IRON REAGENT
K964913 · JIY
Derma Media Lab., Inc.
Chemistry · 73d
Cleared Feb 20, 1997
LYPHOCHEK COAGULATION CONTROL
K964963 · GGN
Bio-Rad
Hematology · 71d
Cleared Feb 20, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH...
K964982 · CEP
Johnson & Johnson Clinical...
Chemistry · 70d
Cleared Feb 20, 1997
THE ADVANCED OSMOMETER (3900)
K965036 · JJM
Advanced Instruments, Inc.
Chemistry · 65d
Cleared Feb 20, 1997
ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON
K965064 · HEB
Rostam , Ltd.
Obstetrics & Gynecology · 64d
Cleared Feb 20, 1997
ACCUMETER H. PYLORI TEST
K965099 · LYR
Chemtrak, Inc.
Microbiology · 62d
Cleared Feb 20, 1997
TUMOR MARKER CONTROL
K965114 · JJY
Diagnostic Products Corp.
Immunology · 62d
Cleared Feb 20, 1997
ABBOTT TESTPACK PLUS HCG COMBO WITH OBC
K965116 · JHI
Abbott Laboratories
Chemistry · 62d