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
83401–83424 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 2000
MIDMARK M4*9 EASYCLAVE STEAM STERILIZER
K992744 · FLE
Midmark Corp.
General Hospital · 147d
Cleared Jan 10, 2000
BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR
K992767 · JOJ
Albert Browne , Ltd.
General Hospital · 146d
Cleared Jan 10, 2000
ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE
K992859 · CHL
Radiometer America, Inc.
Chemistry · 138d
Cleared Jan 10, 2000
AUTOMATED OPHTHALMICS SOFTIPS
K992998 · HKY
Automated Ophthalmics, Inc.
Ophthalmic · 125d
Cleared Jan 10, 2000
RADID DRUG SCREEN 5-PANEL TEST
K993151 · DJG
American Bio Medica Corp.
Toxicology · 111d
Cleared Jan 10, 2000
FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL...
K993411 · HIR
Mega Electronics , Ltd.
Gastroenterology & Urology · 90d
Cleared Jan 10, 2000
AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT
K993522 · JAI
Aktina Medical Physics Corp.
Radiology · 84d
Cleared Jan 10, 2000
FRIALIT-2 BONE PROFILER
K993560 · DZE
Friadent GmbH
Dental · 81d
Cleared Jan 10, 2000
MDI SM/RNP TEST
K993635 · LJM
Micro Detect, Inc.
Immunology · 75d
Cleared Jan 10, 2000
MDI SS-A TEST
K993636 · LJM
Micro Detect, Inc.
Immunology · 75d
Cleared Jan 10, 2000
CLINICAL BLOOD GAS MIXTURE
K993789 · CHL
General Air Service and Supply
Chemistry · 62d
Cleared Jan 10, 2000
CERGOGOLD
K993897 · EIH
Degussa - Ney Dental, Inc.
Dental · 55d
Cleared Jan 10, 2000
HARDYDISK DOXYCYCLINE, 30MCG
K994051 · JTN
Hardy Diagnostics
Microbiology · 41d
Cleared Jan 10, 2000
TITAN RC TACK
K994269 · MAI
Innovasive Devices, Inc.
Orthopedic · 21d
Cleared Jan 07, 2000
FLOSENSE, MODEL 29-8010
K990962 · JAX
Sdi Diagnostics, Inc.
Anesthesiology · 291d
Cleared Jan 07, 2000
SALTER AIRE COMPRESSOR
K992285 · CAF
Salter Labs
Anesthesiology · 184d
Cleared Jan 07, 2000
NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES
K992455 · DQA
Nihon Kohden America, Inc.
Anesthesiology · 168d
Cleared Jan 07, 2000
MAGSTIM RAPID
K992911 · GWF
Magstim Corporation US
Neurology · 130d
Cleared Jan 07, 2000
VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)
K993039 · MRH
Bausch & Lomb, Inc.
Ophthalmic · 119d
Cleared Jan 07, 2000
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z44
K993426 · DXN
Rossmax International , Ltd.
Cardiovascular · 87d
Cleared Jan 07, 2000
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z40
K993429 · DXN
Rossmax International , Ltd.
Cardiovascular · 87d
Cleared Jan 07, 2000
THE AUTOTAC SYSTEM
K993493 · DZL
BioHorizons Implant Systems, Inc.
Dental · 84d
Cleared Jan 07, 2000
MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY STENT,...
K994156 · FGE
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Jan 07, 2000
AUTOMATED CORE BIOPSY DEVICE
K994272 · KNW
Promex, Inc.
Gastroenterology & Urology · 18d