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
72889–72912 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 23, 2002
CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM
K023341 · LLZ
Barco N.V.
Radiology · 77d
Cleared Dec 23, 2002
AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)
K023396 · CIJ
Pointe Scientific, Inc.,
Chemistry · 75d
Cleared Dec 23, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN - 0.25-16 UG/ML
K023527 · LON
Becton, Dickinson & CO
Microbiology · 63d
Cleared Dec 23, 2002
MP-1 MICRO PERIMETER
K023719 · HKI
Nidek Technologies Srl
Ophthalmic · 48d
Cleared Dec 23, 2002
Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN
K023877 · LLZ
Philips Ultrasound, Inc.
Radiology · 32d
Cleared Dec 23, 2002
RUSCH MICROLARYNGEAL TUBE
K023964 · BTR
Rusch Intl.
Anesthesiology · 24d
Cleared Dec 20, 2002
MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES
K012691 · CBK
Acutronic Medical Systems AG
Anesthesiology · 493d
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