Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
79033–79056 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 10, 2001
HISPEED X/I SMART GANTRY OPTION
K012385 · JAK
Ge Medical Systems, Inc.
Radiology · 14d
Cleared Aug 10, 2001
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM
K012389 · KPR
Ge Medical Systems, Inc.
Radiology · 14d
Cleared Aug 09, 2001
INTRALASE 600C LASER KERATOME
K002890 · GEX
Intra Lase Corp.
General & Plastic Surgery · 328d
Cleared Aug 09, 2001
OSSTELL RESONANCE FREQUENCY ANALYZER
K003714 · EKX
Integration Diagnostics, Ltd.
Dental · 251d
Cleared Aug 09, 2001
XUB EXTERNAL ULTRASOUND
K010702 · IMI
Kmi Kolster Methods, Inc.
Physical Medicine · 154d
Cleared Aug 09, 2001
MUSCLE STIMULATOR SA-100
K010807 · IPF
Health@Fitness Technologies, Inc.
Physical Medicine · 146d
Cleared Aug 09, 2001
ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM
K011320 · DQA
Hitachi Medical Systems America, Inc.
Anesthesiology · 100d