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
75313–75336 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 02, 2002
GUIDANT BALLOON CATHETER, SEVERAL MODELS
K021283 · DQO
Guidant Corp.
Cardiovascular · 14d
Cleared May 02, 2002
EASYTRAK GUIDING CATHETER
K021284 · DQY
Guidant Corp.
Cardiovascular · 14d
Cleared May 02, 2002
HI-TORQUE EXTRA S'PORT GUIDEWIRE
K021285 · DQX
Guidant Corp.
Cardiovascular · 14d
Cleared May 01, 2002
KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS
K011859 · DWJ
Klimamed Technologie Medizingerate GmbH
Cardiovascular · 321d
Cleared May 01, 2002
KENDALL, SEQUENTIAL COMPRESSION DEVICE
K012614 · JOW
Medical Instruments Technology, Inc.
Cardiovascular · 261d
Cleared May 01, 2002
FRC POSTEC
K013802 · ELR
Ivoclar Vivadent, Inc.
Dental · 167d
Cleared May 01, 2002
FIXATION (STEINMANN) PINS
K013888 · HTY
Miltex, Inc.
Orthopedic · 159d
Cleared May 01, 2002
SAFE SHIELD POWEDER-FREE LATEX EXAMINATION GLOVES
K020053 · LYY
Safe Shield Co., Ltd.
General Hospital · 113d
Cleared May 01, 2002
SOLO ORTHO 3
K020502 · DYH
Sybron Dental Specialties, Inc.
Dental · 76d