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
75817–75840 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 2002
DEGOTZEN SYNCHRO
K021245 · EHD
The Gotzen Group, Inc.
Radiology · 14d
Cleared May 02, 2002
TRANSSEPTAL NEEDLE/TROCAR
K011727 · DRC
Thomas Medical Products, Inc.
Cardiovascular · 332d
Cleared May 02, 2002
TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING...
K013484 · DRF
Stereotaxis, Inc.
Cardiovascular · 195d
Cleared May 02, 2002
GIVEN DIAGNOSTIC SYSTEM
K020341 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 90d
Cleared May 02, 2002
RPX TITANIUM CEMNT RESTRICTOR
K020344 · JDK
Sulzer Spine-Tech
Orthopedic · 90d
Cleared May 02, 2002
ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING...
K020348 · JZO
Axis-Shield Diagnostics, Ltd.
Immunology · 87d
Cleared May 02, 2002
ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS
K020349 · JZO
Axis-Shield Diagnostics, Ltd.
Immunology · 87d
Cleared May 02, 2002
SYSTEM 2000 CONTROLLER, SYSTEM 5000 CONTROLLER, FOOTSWITCH, POWER CORD, AND...
K020408 · GEI
Arthrocare Corp.
General & Plastic Surgery · 84d
Cleared May 02, 2002
HIVOX EAR THERMOMETER, TS SERIES
K020471 · FLL
Hivox Biotek, Inc.
General Hospital · 79d
Cleared May 02, 2002
AKUPORT M1
K020567 · GZO
Vibrant Health
Neurology · 71d
Cleared May 02, 2002
DUOPRO SAFETY SYRINGE (DUOPROSS)
K020623 · MEG
M.K. Meditech Co. , Ltd.
General Hospital · 65d
Cleared May 02, 2002
DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300
K020687 · JZO
Axis-Shield Diagnostics, Ltd.
Immunology · 59d
Cleared May 02, 2002
SYNTEX POWDER-FREE POLYMER-COATED NITRILE EXAMINATION GLOVE
K020751 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 56d
Cleared May 02, 2002
VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596
K020752 · MID
Pharmacia Deutschland GmbH
Immunology · 56d
Cleared May 02, 2002
VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796
K020757 · MID
Pharmacia Deutschland GmbH
Immunology · 56d
Cleared May 02, 2002
VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696
K020758 · MID
Pharmacia Deutschland GmbH
Immunology · 56d
Cleared May 02, 2002
VERDICT-II PROPOXYPHENE
K020787 · JXN
Medtox Diagnostics, Inc.
Toxicology · 52d
Cleared May 02, 2002
MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
K020930 · MRC
Menicon Co, Ltd.
Ophthalmic · 41d
Cleared May 02, 2002
VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA
K021074 · FAJ
Olympus America, Inc.
Gastroenterology & Urology · 30d
Cleared May 02, 2002
JOGUIDE CARDIOVASCULAR GUIDING C ATHETER
K021088 · DQY
Jomed Catheter, Inc.
Cardiovascular · 28d
Cleared May 02, 2002
TTI THERMOMED MODEL 1.8 INSTRUMENT
K021117 · GEI
Thermosurgery Technologies, Inc.
General & Plastic Surgery · 24d
Cleared May 02, 2002
RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL...
K021120 · DQY
Arrow Intl., Inc.
Cardiovascular · 24d
Cleared May 02, 2002
Y.E.S 10 WHEELCHAIR
K021255 · ITI
Movingpeople.Net
Physical Medicine · 13d
Cleared May 02, 2002
LV-1 HEMOSTASIS VALVE, MODEL #6789
K021282 · DTL
Guidant Corp.
Cardiovascular · 14d