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
74017–74040 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2002
MODIFICATION TO NANMA VACUUM PUMP
K013113 · LKY
Nanma Mfg Co., Ltd.
Gastroenterology & Urology · 458d
Cleared Dec 20, 2002
GYNEFLEX
K021115 · HIR
Naissance Holdings, LC
Gastroenterology & Urology · 256d
Cleared Dec 20, 2002
VACUUM ASSISTED CLOSURE
K021500 · OMP
Kinetic Concepts, Inc.
General & Plastic Surgery · 225d
Cleared Dec 20, 2002
TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES
K021826 · KWZ
Zimmer, Inc.
Orthopedic · 199d
Cleared Dec 20, 2002
MITEK PDS/PGA STAPLE
K021953 · JDR
Mitek Worldwide
Orthopedic · 190d
Cleared Dec 20, 2002
DENTA PORT
K022147 · LQY
J. Morita USA, Inc.
Dental · 171d
Cleared Dec 20, 2002
SPECTRAPULSE
K022607 · GEX
Primary Technology, LLC
General & Plastic Surgery · 136d
Cleared Dec 20, 2002
RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES
K022914 · GXZ
Rhythmlink International, LLC
Neurology · 108d
Cleared Dec 20, 2002
VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02
K023154 · DXC
Vascular Control Systems, Inc.
Radiology · 88d
Cleared Dec 20, 2002
DRX5000
K023160 · ITH
Axiom Usa., Inc.
Physical Medicine · 88d
Cleared Dec 20, 2002
CANDELA GENTLE YAG LASER SYSTEM
K023193 · GEX
Candela Corp.
General & Plastic Surgery · 86d
Cleared Dec 20, 2002
SYDNEY IVF HYALURONIDASE
K023353 · MQL
Cook Urological, Inc.
Obstetrics & Gynecology · 74d
Cleared Dec 20, 2002
COOPERSURGICAL MALLEABLE SYTLET
K023382 · MQF
Cooper Surgical
Obstetrics & Gynecology · 73d
Cleared Dec 20, 2002
ACCESS TOTAL BHCG
K023480 · JHI
Beckman Coulter, Inc.
Chemistry · 64d
Cleared Dec 20, 2002
DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE
K023554 · KGI
Ge Lunar Corp.
Radiology · 58d
Cleared Dec 20, 2002
STAT PROFILE PHOX PLUS L ANALYZER
K023567 · CHL
Nova Biomedical Corp.
Chemistry · 58d
Cleared Dec 20, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K023858 · LON
Becton, Dickinson & CO
Microbiology · 30d
Cleared Dec 20, 2002
FLEXIMA BILIARY CATHETER
K023870 · FGE
Boston Scientific/Medi-Tech
Gastroenterology & Urology · 30d
Cleared Dec 20, 2002
HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO
K023883 · MEB
I-Flow Corp.
General Hospital · 29d
Cleared Dec 20, 2002
COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197
K023922 · HWC
Coapt Systems, Inc.
Orthopedic · 25d
Cleared Dec 20, 2002
MODIFICATION TO MEDIPRIME
K023936 · LLZ
Algotec Systems, Ltd.
Radiology · 24d
Cleared Dec 20, 2002
VOYAGER LINUX
K023975 · HAW
Z-Kat, Inc.
Neurology · 18d
Cleared Dec 20, 2002
XTJF-160AF DUODENOVIDEOSCOPE
K024033 · FDT
Olympus Optical Co., Ltd.
Gastroenterology & Urology · 14d
Cleared Dec 20, 2002
PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-5000
K024036 · IPF
Johari Digital Healthcare , Ltd.
Physical Medicine · 14d