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
77905–77928 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 2001
BACK-UP MEIER GUIDEWIRE
K011906 · DQX
Boston Scientific Corp
Cardiovascular · 55d
Cleared Aug 13, 2001
GULLIVER AND CLASSE A
K012213 · EIA
American Dental Technologies, Inc.
Dental · 28d
Cleared Aug 10, 2001
SMARTWAVE IF 2000
K003631 · LIH
Newwave Medical, LLC
Neurology · 259d
Cleared Aug 10, 2001
QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD...
K010039 · NBW
Chronimed, Inc.
Chemistry · 217d
Cleared Aug 10, 2001
VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE
K010544 · DYH
Apex Dental Materials, Inc.
Dental · 168d
Cleared Aug 10, 2001
CYBERKNIFE SYSTEM
K011024 · IYE
Accuray, Inc.
Radiology · 128d
Cleared Aug 10, 2001
REUSABLE GLASS SYRINGES
K011176 · FMF
Lockett Medical Corp.
General Hospital · 115d
Cleared Aug 10, 2001
ROSS EMBRACE PUMP SET
K011467 · KNT
Ross Products
Gastroenterology & Urology · 88d
Cleared Aug 10, 2001
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL...
K011472 · FFX
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 88d
Cleared Aug 10, 2001
OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1
K011484 · FBK
Olympus Optical Co., Ltd.
Gastroenterology & Urology · 88d
Cleared Aug 10, 2001
CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS,...
K011496 · FBO
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 87d
Cleared Aug 10, 2001
MP3U, POWER WHEELCHAIR
K011513 · ITI
Merits Health Products., Inc.
Physical Medicine · 86d
Cleared Aug 10, 2001
SPERMCATCH
K011607 · MQL
Nidacon International AB
Obstetrics & Gynecology · 78d
Cleared Aug 10, 2001
KOALA CLAMP, KOALA CLAMP AND CUTTER
K011621 · HFW
Maternus, Inc.
Obstetrics & Gynecology · 77d
Cleared Aug 10, 2001
CERVILENZ UTERINE MEASURING SOUND
K011840 · HHM
Cervilenz, Inc.
Obstetrics & Gynecology · 59d
Cleared Aug 10, 2001
GENZYME DIRECT-AMYLASE TEST REAGENT
K011843 · JFJ
Genzyme Corp.
Chemistry · 59d
Cleared Aug 10, 2001
HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05
K011928 · FPA
Northgate Technologies, Inc.
General Hospital · 51d
Cleared Aug 10, 2001
OLYMPUS SPRAY CATHETER PW-6C-1
K012073 · EOQ
The Olympus Optical Co.
Ear, Nose, Throat · 39d
Cleared Aug 10, 2001
KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS
K012155 · LLZ
Eastman Kodak Company
Radiology · 30d
Cleared Aug 10, 2001
DIGORA PCT
K012170 · MUH
Soredex Palodex Group OY
Radiology · 29d
Cleared Aug 10, 2001
MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER
K012239 · IYN
Hitachi Medical Corp.
Radiology · 24d
Cleared Aug 10, 2001
CHASE CARDIOVASCULAR PATCH
K012248 · DXZ
Chase Medical, Inc.
Cardiovascular · 24d
Cleared Aug 10, 2001
SIMPLICITY EURO QD INFUSION SET
K012330 · FPA
Sterling Medivations, Inc.
General Hospital · 18d
Cleared Aug 10, 2001
BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3
K012369 · IYN
Atys Medical
Radiology · 15d