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
38977–39000 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 18, 2014
KASM KNEE ARTICULATING SPACER MOLDS
K133449 · JWH
Ortho Development Corp.
Orthopedic · 98d
Cleared Feb 18, 2014
MEDOS HILITE OXYGENATOR
K140177 · DTZ
Medos Medizintechnik AG
Cardiovascular · 25d
Cleared Feb 14, 2014
L.A.M. IPM WOUND GEL, IPM DERM GEL
K130781 · FRO
Glycobiosciences, Inc.
General & Plastic Surgery · 330d
Cleared Feb 14, 2014
NMI DIALYSIS CATHETER
K131260 · MSD
Navilyst Medical, Inc.
Gastroenterology & Urology · 288d
Cleared Feb 14, 2014
TREZ_HD
K131266 · GWQ
Excel-Tech Ltd. (Xltek)
Neurology · 287d
Cleared Feb 14, 2014
BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR
K132192 · FCX
Bracco Diagnostic, Inc.
Gastroenterology & Urology · 214d
Cleared Feb 14, 2014
DENTAL BONE SCREWS
K132212 · DZL
Hager& Meisinger GmbH
Dental · 213d
Cleared Feb 14, 2014
SYLPHAR REMESENSE SENSITIVITY RELIEF STRIPS
K132426 · LBH
Sylphar N.V.
Dental · 193d
Cleared Feb 14, 2014
VICTUS FEMTOSECOND LASER PLATFORM
K132534 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 185d
Cleared CT Feb 14, 2014
REVEAL LINQ INSERTABLE CARDIAC MONITOR
K132649 · MXD
Medtronic, Inc.
Cardiovascular · 172d
Cleared Feb 14, 2014
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML)
K132909 · LON
Becton, Dickinson and Company
Microbiology · 150d
Cleared Feb 14, 2014
STELLARIS VISION ENHANCEMENT SYSTEM
K133242 · HQC
Bausch & Lomb
Ophthalmic · 116d
Cleared Feb 14, 2014
XCATH
K133296 · DYB
Alseal
Cardiovascular · 112d
Cleared Feb 14, 2014
POWERPORT IMPLANTABLE PORT
K133335 · LJT
C.R. Bard, Inc.
General Hospital · 108d
Cleared Feb 14, 2014
AIRSTRIP REMOTE PATIENT MONITORING
K133450 · MWI
Airstrip Technologies, LP
Cardiovascular · 95d
Cleared Feb 14, 2014
ANGIOJET ULTRA AVX THROMBECTOMY SET
K133629 · QEW
Possis Medical, Inc.
Cardiovascular · 80d
Cleared Feb 14, 2014
MD302C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR
K133708 · LLZ
Nec Display Solutions , Ltd.
Radiology · 72d
Cleared Feb 14, 2014
VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICE
K134004 · DRG
Cellco Partnership D/B/A Verizon...
Cardiovascular · 49d
Cleared Feb 14, 2014
3MP GRAYSCAKE LCD DISPLAY
K140103 · LLZ
Shenzhen Beacon Display Technology...
Radiology · 30d
Cleared Feb 14, 2014
3MP COLOR LCD DISPLAY
K140108 · LLZ
Shenzhen Beacon Display Technology...
Radiology · 30d
Cleared Feb 14, 2014
NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE
K140136 · FOZ
Nipro Medical Corporation
General Hospital · 28d
Cleared Feb 13, 2014
INTRODUCER SETS, MODEL ADELANTE RADIAL
K130633 · DYB
Oscor, Inc.
Cardiovascular · 339d
Cleared Feb 13, 2014
MANUAL WHEELCHAIR
K132257 · IOR
Zhejiang Jiafeng Electrical &...
Physical Medicine · 209d
Cleared Feb 13, 2014
PALS PLATINUM NEUROSTIMULATION ELECTRODES
K132422 · GXY
Axelgaard Mfg. Co., Ltd.
Neurology · 192d