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
72601–72624 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 2003
PEGASUS NASAL CPAP SYSTEM
K022192 · BZD
Sensor Medics Corp.
Anesthesiology · 203d
Cleared Jan 24, 2003
NEOGENESYS 2K
K022433 · LIH
Sanexas Intl. GmbH
Neurology · 183d
Cleared Jan 24, 2003
VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V
K022445 · HIH
Olympus Optical Co., Ltd.
Obstetrics & Gynecology · 183d
Cleared Jan 24, 2003
TEH LIN JUPITER POWER CHAIR, MODEL TL-320
K022697 · ITI
Teh Lin Prosthetic & Orthopaedic, Inc.
Physical Medicine · 164d
Cleared Jan 24, 2003
WU'S 3-WHEELED NEO SCOOTER, WT-L3
K023040 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 134d
Cleared Jan 24, 2003
EPW POWERED WHEELCHAIR, GP-201
K023148 · ITI
Emg Technology Co., Ltd.
Physical Medicine · 126d
Cleared Jan 24, 2003
WU'S 3-WHEELED NEO SCOOTER, WT-M4
K023166 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 123d
Cleared Jan 24, 2003
WU'S 3-WHEELED NEO SCOOTER, WT-T3B
K023168 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 123d
Cleared Jan 24, 2003
PICUS ULTRASOUND IMAGING SYSTEMS
K023512 · IYN
Pie Medical
Radiology · 95d
Cleared Jan 24, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K023568 · LON
Becton, Dickinson & CO
Microbiology · 92d
Cleared Jan 24, 2003
SILVERLON CONTACT WOUND DRESSING
K023612 · FRO
Argentum International, LLC
General & Plastic Surgery · 88d
Cleared Jan 24, 2003
PICCOLO TRIGLYCERIDES TEST SYSTEM
K023639 · JGY
Abaxis, Inc.
Chemistry · 86d
Cleared Jan 24, 2003
PICCOLO HDL TEST SYSTEM
K023640 · LBS
Abaxis, Inc.
Chemistry · 86d
Cleared Jan 24, 2003
PICCOLO TOTAL CHOLESTEROL TEST SYSTEM
K023642 · CHH
Abaxis, Inc.
Chemistry · 86d
Cleared Jan 24, 2003
INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PLEVIS COIL
K023650 · MOS
Usa Instruments, Inc.
Radiology · 86d
Cleared Jan 24, 2003
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE-BLUE COLOR
K023826 · LYY
Syntex Healthcare Products Co., Ltd.
General Hospital · 67d
Cleared Jan 24, 2003
UCP DENTAL MATERIAL
K023831 · EJT
Precious Chemicals U.S.A., Inc.
Dental · 67d
Cleared Jan 24, 2003
POWDER FREE POLYMER COATED (ACRYLIC BASED) PATIENT EXAMINIATION GLOVES
K023866 · LYY
Kl-Kepong Rubber Products Sdn. Bhd.
General Hospital · 65d
Cleared Jan 24, 2003
GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
K023878 · NFA
Medtronic Vascular
Cardiovascular · 64d
Cleared Jan 24, 2003
QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS
K023970 · IZI
Medis Medical Imaging Systems BV
Radiology · 56d
Cleared Jan 24, 2003
PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM
K023977 · LYY
Starmatrix Sdn Bhd
General Hospital · 53d
Cleared Jan 24, 2003
NITRILE EXAMINATION GLOVES, POWDER FREE
K023978 · LZA
Starmatrix Sdn Bhd
General Hospital · 53d
Cleared Jan 24, 2003
NITRILE EXAMINATION GLOVES, PRE-POWDERED
K023979 · LZA
Starmatrix Sdn Bhd
General Hospital · 53d
Cleared Jan 24, 2003
NITREX NITINOL GUIDEWIRE
K024021 · DQX
Ev3 Corporation
Cardiovascular · 50d