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
39889–39912 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 2013
SMITH & NEPHEW ULTRATAPE
K132357 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 93d
Cleared Oct 30, 2013
SUNTOUCH EYE SPEAR
K132796 · HOZ
Huizhou Foryou Medical Devices Co., Ltd.
Ophthalmic · 54d
Cleared Oct 30, 2013
IMMULITE 2000
K133122 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 30d
Cleared Oct 29, 2013
WOUNDWASH SALINE SPRAY
K123910 · FRO
Neilmed Pharmaceuticals, Inc.
General & Plastic Surgery · 314d
Cleared Oct 29, 2013
REVERSE SHOULDER PROSTHESIS MONOBLOCK
K130048 · KWS
Encore Medical, L.P.
Orthopedic · 294d
Cleared Oct 29, 2013
NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS
K130117 · HOZ
Network Medical Products, Ltd.
Ophthalmic · 286d
Cleared Oct 29, 2013
INSPIRATION VENTILATOR SYSTEM 5I/7I
K130178 · CBK
eVent Medical, Ltd.
Anesthesiology · 277d
Cleared Oct 29, 2013
BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM
K130274 · MAX
Elite Surgical Supplies (Pty), Ltd.
Orthopedic · 267d
Cleared Oct 29, 2013
MYPATCH
K131190 · DSH
Dms-Service, LLC
Cardiovascular · 186d
Cleared Oct 29, 2013
2.5MM INLINE FUSION PLATE
K131867 · HRS
Biomet, Inc.
Orthopedic · 127d
Cleared Oct 29, 2013
GUIDOR BIORESORBABLE MATRIX BARRIER
K132325 · NPK
Sunstar Americas, Inc.
Dental · 95d
Cleared Oct 28, 2013
JIAJIAN POINTOSELECT DIGITAL
K123958 · GZJ
Wuxi Jiajian Medical Instrument Co.,...
Neurology · 311d
Cleared Oct 28, 2013
TX WHEELCHAIR CHASSIS
K131336 · IOR
Jcm Seating Solutions, Ltd.
Physical Medicine · 172d
Cleared Oct 28, 2013
INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES
K131446 · DQR
Integra LifeSciences Corporation
Cardiovascular · 161d
Cleared Oct 28, 2013
AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35
K132083 · KRD
MicroVention, Inc.
Cardiovascular · 115d
Cleared Oct 28, 2013
SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM
K132126 · MRW
Spectrum Spine, LLC
Orthopedic · 110d
Cleared Oct 28, 2013
S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE
K132462 · CDN
Hitachi Chemical Diagnostics, Inc.
Chemistry · 82d
Cleared Oct 28, 2013
ITCLAMP 50
K132651 · DXC
Innovative Trauma Care, Inc.
Cardiovascular · 63d
Cleared Oct 28, 2013
NAUTILUS SPINAL SYSTEM
K132866 · NKB
Life Spine, Inc.
Orthopedic · 45d
Cleared Oct 28, 2013
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE
K132972 · DTN
Medtronic, Inc.
Cardiovascular · 35d
Cleared Oct 25, 2013
MEDUSA VASCULAR PLUG
K123696 · KRD
Endoshape, Inc.
Cardiovascular · 326d
Cleared Oct 25, 2013
IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA
K123713 · MVM
Immco Diagnostics, Inc.
Immunology · 325d
Cleared Oct 25, 2013
COVAMESH
K130428 · FTL
Biomup S.A.
General & Plastic Surgery · 247d
Cleared Oct 25, 2013
TRIA FAN SYSTEM
K130459 · ONG
Tria Beauty, Inc.
General & Plastic Surgery · 245d