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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
86785–86808 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 1999
RDI DIRECT LDL CHOLESTEROL TEST
K984107 · MRR
Reference Diagnostics, Inc.
Chemistry · 72d
Cleared Jan 28, 1999
MS400
K984113 · IPF
Lsi Intl., Inc.
Physical Medicine · 72d
Cleared Jan 28, 1999
IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC5
K984132 · DCK
Diagnostic Products Corp.
Immunology · 71d
Cleared Jan 28, 1999
QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELISA
K984137 · MVM
Inova Diagnostics, Inc.
Immunology · 71d
Cleared Jan 28, 1999
P.F.C. MODULAR PLUS OFFSET TIBIAL TRAY
K984158 · JWH
Depuy, Inc.
Orthopedic · 70d
Cleared Jan 28, 1999
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT
K984303 · LBR
Ortho-Clinical Diagnostics, Inc.
Chemistry · 57d
Cleared Jan 28, 1999
BIOABSORBABLE INTERFERENCE SCREWS
K984320 · HWC
Smith & Nephew, Inc.
Orthopedic · 56d
Cleared Jan 28, 1999
MECHANICAL WHEELCHAIR
K984354 · IOR
Colours 'N Motion
Physical Medicine · 55d
Cleared Jan 28, 1999
ACTIVX
K984367 · IOR
Adorno Rogers Technology
Physical Medicine · 52d
Cleared Jan 28, 1999
BIRCOLL BALLOON DISSECTOR
K984448 · FZW
Wells Johnson Co.
General & Plastic Surgery · 45d
Cleared Jan 28, 1999
DEPUY PROFILE FEMORAL HIP WITH POROCOAT
K984459 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 44d
Cleared Jan 28, 1999
HEMOCHEK SAMPLE COLLECTION KIT
K984529 · LCP
Osborn Laboratories, Inc.
Hematology · 38d
Cleared Jan 28, 1999
OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS
K990059 · MNI
Howmedica Osteonics Corp.
Orthopedic · 20d
Cleared Jan 28, 1999
ABBOTT LIQUID CSF CONTROL, MODEL #'S 1E98-01, 1E99-01
K990161 · JJY
Bio-Rad
Chemistry · 9d
Cleared Jan 28, 1999
ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01
K990162 · JJX
Bio-Rad
Chemistry · 9d
Cleared Jan 27, 1999
AURORA
K972065 · DQY
Neurovena Corp.
Cardiovascular · 603d
Cleared Jan 27, 1999
ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
K972616 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 562d
Cleared Jan 27, 1999
GT LEGGIERO
K981359 · DQY
Terumo Medical Corp.
Cardiovascular · 288d
Cleared Jan 27, 1999
LACTOSORB MENISCAL REPAIR DEVICE
K982095 · MAI
Biomet, Inc.
Orthopedic · 226d
Cleared Jan 27, 1999
INVACARE CPAP
K982242 · BZD
Invacare Corp.
Anesthesiology · 216d
Cleared Jan 27, 1999
MERCATOR
K982384 · DSH
Harley Street Software , Ltd.
Cardiovascular · 203d
Cleared Jan 27, 1999
CHAIT CECOSTOMY CATHETER
K982500 · KNT
Cook, Inc.
Gastroenterology & Urology · 191d
Cleared Jan 27, 1999
VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM
K982506 · GEH
Cryosurgery, Inc.
General & Plastic Surgery · 191d
Cleared Jan 27, 1999
MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006, 7007,...
K982540 · MTD
Cardiac Pathways Corp.
Cardiovascular · 190d