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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
36961–36984 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 06, 2014
NOVASHIELD INJECTABLE NASAL PACKING AND STENT
K141704 · LYA
Medtronic, Inc.
Ear, Nose, Throat · 104d
Cleared CT Oct 06, 2014
ULTRASHAPE SYSTEM
K141708 · OHV
Syneron Medical, Ltd.
General & Plastic Surgery · 104d
Cleared Oct 06, 2014
STARBAND, STARLIGHT
K141842 · MVA
Orthomerica Products, Inc.
Neurology · 90d
Cleared Oct 06, 2014
SHARKCORE FINE NEEDLE BIOPSY SYSTEM
K141894 · FCG
Covidien, LLC( Formerly Beacon...
Gastroenterology & Urology · 84d
Cleared Oct 06, 2014
DIODE LASER HAIR REMOVAL SYSTEM
K141973 · GEX
Beijing Anchorfree Technology Co., Ltd.
General & Plastic Surgery · 77d
Cleared Oct 06, 2014
LiNA SafeAir Smoke Pencil
K142538 · GEI
Lina Medical Aps
General & Plastic Surgery · 27d
Cleared Oct 03, 2014
MSA100 PEAK FLOW METER
K133975 · BZH
Beijing M&B Electronic Instruments...
Anesthesiology · 281d
Cleared Oct 03, 2014
FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER
K140062 · NVP
Fsc Laboratories, Inc.
Anesthesiology · 266d
Cleared Oct 03, 2014
CRANIOPLUG
K140309 · GXR
Ossdsign AB
Neurology · 238d
Cleared Oct 03, 2014
MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC
K140605 · NHJ
Dima Italia Srl
Anesthesiology · 207d
Cleared Oct 03, 2014
SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER
K141139 · NCX
Zoll Circulation
Neurology · 154d
Cleared Oct 03, 2014
FORUM GLAUCOMA WORKPLACE
K141297 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 137d
Cleared Oct 03, 2014
HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY
K141502 · MTJ
Orthocon, Inc.
General & Plastic Surgery · 119d
Cleared Oct 03, 2014
FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KIT
K141743 · MQB
Radiology Solutions, LLC
Radiology · 95d
Cleared Oct 03, 2014
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
K141765 · MQB
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 94d
Cleared Oct 03, 2014
Viberect Penile Vibratory Stimulation Device
K142304 · KXQ
Reflexonic, LLC
Obstetrics & Gynecology · 46d
Cleared Oct 03, 2014
MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM
K142442 · HWC
Zimmer, Inc.
Orthopedic · 31d
Cleared Oct 03, 2014
UGEO PT60A Diagnostic Ultrasound System
K142466 · IYN
Samsung Medison Co., Ltd.
Radiology · 31d
Cleared Oct 03, 2014
HyProCure II
K142534 · HWC
Graham Medical Technologies, LLC Dba...
Orthopedic · 24d
Cleared Oct 03, 2014
21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220)
K142536 · PGY
Jvckenwood Corporation
Radiology · 24d
Cleared Oct 03, 2014
24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244)
K142540 · PGY
Jvckenwood Corporation
Radiology · 24d
Cleared Oct 02, 2014
Electro Auricular Device
K140530 · BWK
Navigant Consulting, Inc.
Neurology · 212d
Cleared Oct 02, 2014
JUGGERKNOT MINI SOFT ANCHOR
K140908 · DZL
Biomet Sports Medicine
Dental · 176d
Cleared Oct 02, 2014
PADI-LOCK
K141200 · FPA
Padi-Lock, LLC
General Hospital · 146d