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
74953–74976 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 2002
MULTIGAS UNIT, MODEL AG-920RA
K020046 · CCK
Nihon Kohden America, Inc.
Anesthesiology · 199d
Cleared Jul 25, 2002
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K021061 · KWP
Medtronic Sofamor Danek
Orthopedic · 114d
Cleared Jul 25, 2002
ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2
K021316 · LBS
Genzyme Corp.
Chemistry · 91d
Cleared Jul 25, 2002
ORTHOPILOT HTO MODULE
K021327 · HAW
Aesculap, Inc.
Neurology · 90d
Cleared Jul 25, 2002
MAGNETOM TRIO QUADRATURE TX/RX HEAD COIL
K021330 · MOS
Usa Instruments, Inc.
Radiology · 90d
Cleared Jul 25, 2002
NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE
K021336 · MQV
Novabone Products, LLC
Orthopedic · 90d
Cleared Jul 25, 2002
TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540
K021504 · FLE
Tuttnauer U.S.A Co, Ltd.
General Hospital · 77d
Cleared Jul 25, 2002
K-ASSAY LP(A) ASSAY
K021660 · DFC
Kamiya Biomedical Co.
Chemistry · 66d
Cleared Jul 25, 2002
STAT PROFILE PHOX PLUS C ANALYZER
K021713 · CHL
Nova Biomedical Corp.
Chemistry · 63d
Cleared Jul 25, 2002
BRIGHT GOLD
K021892 · EJT
Ivoclar Vivadent, Inc.
Dental · 48d
Cleared Jul 25, 2002
CLARREN HELMET (ORTHOMERICA)
K021918 · OAN
Orthomerica Products, Inc.
Neurology · 44d
Cleared Jul 25, 2002
AUROPAL 60
K021926 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 43d
Cleared Jul 25, 2002
36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
K022077 · JDI
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Jul 25, 2002
J&S MEDICAL SENTRY URINE DIPSTICK CONTROL
K022085 · JJW
J & S Medical Assoc., Inc.
Chemistry · 28d
Cleared Jul 25, 2002
PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING
K022094 · JDI
Biomet, Inc.
Orthopedic · 28d
Cleared Jul 25, 2002
THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050
K022108 · JIX
Thermo Dma, Inc.
Chemistry · 27d
Cleared Jul 25, 2002
EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE
K022119 · EFB
Electro Medical Systems SA
Dental · 24d
Cleared Jul 25, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MOXIFLOXACIN 0.125-8 UG/ML
K022129 · LON
Becton, Dickinson & CO
Microbiology · 24d
Cleared Jul 25, 2002
CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES
K022169 · KNW
Parallax Medical, Inc.
Gastroenterology & Urology · 22d
Cleared Jul 25, 2002
VECTOR MEDICAL, INC., VECTOR TARGETING SYSTEM
K022225 · HSB
Vector Medical, Inc.
Orthopedic · 15d
Cleared Jul 25, 2002
MODOFOCATION TO SYNTHES ANKLE ARTHRODESIS PLATES
K022255 · HRS
Synthes (Usa)
Orthopedic · 13d
Cleared Jul 24, 2002
CLINDATALINK VERSION 1.0 FOR SPIROMETRY
K020004 · BZG
Compleware Corp.
Anesthesiology · 203d
Cleared Jul 24, 2002
PRISMAFLO
K020103 · KOC
Stihler Electronic GmbH
Gastroenterology & Urology · 194d
Cleared Jul 24, 2002
CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM
K020828 · LTK
Bayer Corp.
Immunology · 132d