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
73993–74016 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 24, 2002
SCOUT BOSS
K023961 · ITI
Burke, Inc.
Physical Medicine · 25d
Cleared Dec 24, 2002
NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160
K023962 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 25d
Cleared Dec 24, 2002
FEMOSTOP FEMORAL COMPRESSION SYSTEM
K024107 · DXC
Radi Medical Systems AB
Cardiovascular · 11d
Cleared Dec 23, 2002
LTFS230
K021775 · LNS
Healthtronics, Inc.
Gastroenterology & Urology · 208d
Cleared Dec 23, 2002
AIM-V (R) MEDIUM, MODEL 087-0112
K022086 · NDS
Invitrogen Corporation
Gastroenterology & Urology · 179d
Cleared Dec 23, 2002
DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE
K022500 · KPO
Rockwell Medical Technologies, Inc.
Gastroenterology & Urology · 147d
Cleared Dec 23, 2002
PAROS CRP
K022690 · DCN
Horiba, Ltd.
Immunology · 132d
Cleared Dec 23, 2002
AIA-PACK CA 19-9
K023239 · NIG
Tosoh Corp.
Immunology · 87d
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