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
41449–41472 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 21, 2013
FIBRILLAR COLLAGEN WOUND DRESSING
K120250 · KGN
Collafirm, LLC
General & Plastic Surgery · 450d
Cleared Apr 21, 2013
DIODE LASER
K123483 · GEX
Beijing Syntech Laser Co., Ltd.
General & Plastic Surgery · 159d
Cleared Apr 19, 2013
PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM
K121804 · EMA
Itena Clinical
Dental · 304d
Cleared Apr 19, 2013
NEWFIX EXTERNAL FIXATION SYSTEM
K122210 · KTT
Tecnologia Y Diseno Industrial, S.A...
Orthopedic · 268d
Cleared Apr 19, 2013
MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM
K122539 · CHL
Siemens Healthcare Diagnostics
Chemistry · 241d
Cleared Apr 19, 2013
BIOSPHERE BIOACTIVE BONE GRAFT PUTTY
K122868 · MQV
Synergy Biomedical, LLC
Orthopedic · 213d
Cleared Apr 19, 2013
INSTINCT JAVA SYSTEM
K123552 · NKB
Zimmer Spine
Orthopedic · 151d
Cleared Apr 19, 2013
AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT
K123716 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 136d
Cleared Apr 19, 2013
ARCOS TROCHANTER BUTTON
K130063 · LPH
Biomet, Inc.
Orthopedic · 99d
Cleared Apr 19, 2013
DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS
K130108 · HRS
Xiamen Double Engine Medical Material...
Orthopedic · 93d
Cleared Apr 19, 2013
PROFEMUR XM DISTAL CENTRALIZER
K130167 · LZO
Wrightmedicaltechnologyinc
Orthopedic · 86d
Cleared Apr 19, 2013
ECAT SCINTRON PET
K130269 · KPS
Miegmbh
Radiology · 74d
Cleared Apr 19, 2013
MASTERGRAFT STRIP
K130335 · MQV
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 67d
Cleared Apr 19, 2013
FALLER STYLET
K130441 · FJS
Medionics International, Inc.
Gastroenterology & Urology · 57d
Cleared Apr 19, 2013
ELECTRODE, FLEXIBLE SUCTION COAGULATOR
K130489 · FEH
Optim, LLC
Gastroenterology & Urology · 53d
Cleared Apr 18, 2013
BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS)
K121659 · PDT
Arcos, Inc.
General & Plastic Surgery · 317d
Cleared Apr 18, 2013
PREXION3D ECLIPSE
K122199 · OAS
The Yoshida Dental Mfg. Co., Ltd.
Radiology · 268d
Cleared Apr 18, 2013
A3F FRATIONAL
K122200 · GEI
Pollogen, Ltd.
General & Plastic Surgery · 267d
Cleared Apr 18, 2013
RHYTHMIA MAPPING CATHETER
K122461 · DRF
Rhythmia Medical, Inc.
Cardiovascular · 248d
Cleared Apr 18, 2013
NEOCLOSE HASSON, NEOCLOSE UNIVERSAL
K123280 · GCJ
Neosurgical, Ltd.
General & Plastic Surgery · 178d
Cleared Apr 18, 2013
CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES
K123676 · OWN
Mauna Kea Technologies
General & Plastic Surgery · 139d
Cleared Apr 18, 2013
SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8
K123900 · MHX
Philips Medical Systems
Cardiovascular · 121d
Cleared Apr 18, 2013
DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM
K124049 · DPT
Spectralmd, Inc.
Cardiovascular · 108d
Cleared Apr 18, 2013
COMINED STANDARD SOLUTION
K130100 · FKH
Mesa Laboratories, Inc.
Gastroenterology & Urology · 93d