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
73393–73416 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 23, 2002
ST AIA-PACK CA 19-9
K023240 · NIG
Tosoh Corp.
Immunology · 87d
Cleared Dec 23, 2002
AMALGA PACS
K023246 · LLZ
Global Care Solutions, S.A.
Radiology · 84d
Cleared Dec 23, 2002
CHAMPION 5000 PERIPHERAL VASCULAR COIL
K023247 · MOS
Usa Instruments, Inc.
Radiology · 84d
Cleared Dec 23, 2002
HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS
K023269 · DCK
Instrumentation Laboratory CO
Chemistry · 83d
Cleared Dec 23, 2002
DISPOSABLE ASPIRATION NEEDLE NA-200H
K023272 · FCG
The Olympus Optical Co.
Gastroenterology & Urology · 83d
Cleared Dec 23, 2002
MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02
K023293 · IYE
Med-Tec,Inc.
Radiology · 82d
Cleared Dec 23, 2002
CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM
K023322 · LLZ
Barco N.V.
Radiology · 80d
Cleared Dec 23, 2002
IMAGETILE
K023339 · LLZ
Barco N.V.
Radiology · 77d
Cleared Dec 23, 2002
CORONIS 1MP MEDICAL FLAT PANEL DISPLAY SYSTEM
K023340 · LLZ
Barco N.V.
Radiology · 77d
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