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
81097–81120 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 2000
HARDYDISK LEVOFLOXACIN, 5MCG
K002664 · JTN
Hardy Diagnostics
Microbiology · 62d
Cleared Oct 26, 2000
NEUROTOLOGY DRAPE, MODEL TBD
K002702 · KKX
Gyrus Ent LLC
General Hospital · 57d
Cleared Oct 26, 2000
300LC ULTRASOUND IMAGING SYSTEMS, MODEL 300LC
K002880 · IYN
Pie Medical
Radiology · 41d
Cleared Oct 26, 2000
STACKHOUSE LENS HOOD, MODEL SA-700/FS
K003194 · FYA
Stackhouse, Inc.
General Hospital · 14d
Cleared Oct 26, 2000
RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)
K003232 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 9d
Cleared Oct 26, 2000
LITEAIRE
K993101 · CAF
Thayer Medical Corp.
Anesthesiology · 406d
Cleared Oct 26, 2000
GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER
K994390 · MSF
Gambro Healthcare
Gastroenterology & Urology · 303d
Cleared Oct 25, 2000
BURR HOLE COVER, MODEL XX
K001096 · GXR
Image-Guided Neurologics, Inc.
Neurology · 204d
Cleared Oct 25, 2000
PIPER
K001295 · MUJ
Rtek Medical Systems, LLC
Radiology · 184d
Cleared Oct 25, 2000
DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001
K001493 · EFS
Air Force, Inc.
Dental · 166d
Cleared Oct 25, 2000
NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM
K001811 · FIP
Neu-Ion, Inc.
Gastroenterology & Urology · 132d
Cleared Oct 25, 2000
DIRECT CROWN
K001884 · EBG
Flexible Dimensions, LLC
Dental · 126d
Cleared Oct 25, 2000
CARDIOBEEPER CB12/12, MODEL CB12/12
K002310 · DXH
Meridian Medical Technologies , Ltd.
Cardiovascular · 86d
Cleared Oct 25, 2000
NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA
K002335 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 85d
Cleared Oct 25, 2000
HARDYDISK STREPTOMYCIN, 300MCG
K002368 · JTN
Hardy Diagnostics
Microbiology · 83d
Cleared Oct 25, 2000
ACCESS ALERT GAUGE
K002372 · KOC
Medisystems Corp.
Gastroenterology & Urology · 82d
Cleared Oct 25, 2000
POWER 5000 GENERAL PURPOSE COIL
K002483 · MOS
Usa Instruments, Inc.
Radiology · 72d
Cleared Oct 25, 2000
OPART, MODEL MRT-600
K002522 · MOS
Toshiba America Mri, Inc.
Radiology · 71d
Cleared Oct 25, 2000
K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE
K002558 · DCK
Kamiya Biomedical Co.
Immunology · 72d
Cleared Oct 25, 2000
HARDYDISK CEFUROXIME, 30MCG
K002656 · JTN
Hardy Diagnostics
Microbiology · 61d
Cleared Oct 25, 2000
MILLENNIUM EDITION 2000 ACCELERATED ELECTROFORMING SYSTEM
K002675 · EJT
Product Development Industries, Inc.
Dental · 58d
Cleared Oct 25, 2000
OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
K002918 · DCN
Olympus America, Inc.
Immunology · 36d
Cleared Oct 25, 2000
OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
K002982 · JJE
Olympus America, Inc.
Chemistry · 30d
Cleared Oct 25, 2000
OSCAR 2, MODEL 222
K003004 · DXN
Suntech Medical Instruments, Inc.
Cardiovascular · 30d