FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
73105–73128 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 2003
PALOMAR Q-YAG ND:YAG LASER SYSTEM
K023967 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 59d
Cleared Jan 27, 2003
VACUETTE TRACE ELEMENTS TUBES
K023971 · JKA
Greiner Bio-One Vacuette North America
Chemistry · 59d
Cleared Jan 27, 2003
ACCURA ELITE SHUNT SYSTEM
K024040 · JXG
Phoenix Biomedical Corp.
Neurology · 52d
Cleared Jan 27, 2003
PHOENIX UNIVERSAL SHUNT SYSTEM
K024101 · JXG
Phoenix Biomedical Corp.
Neurology · 46d
Cleared Jan 27, 2003
LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE
K030002 · FPA
Abbott Laboratories
General Hospital · 25d
Cleared Jan 24, 2003
MUCOGRAFT
K012423 · NPL
Ed. Geistlich Soehne AG Fuer...
Dental · 543d
Cleared Jan 24, 2003
GOOD LUBRICATIONS
K020586 · KMJ
Biofilm, Inc.
General Hospital · 336d
Cleared Jan 24, 2003
FLOWLINE BIOPORE EPTFE VASCULAR GRAFT
K021547 · DSY
Jotec GmbH
Cardiovascular · 259d
Cleared Jan 24, 2003
40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0
K022052 · HIF
Northgate Technologies, Inc.
Obstetrics & Gynecology · 214d
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