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
51481–51504 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 23, 2009
STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL...
K093636 · LIT
Boston Scientific Corp
Cardiovascular · 29d
Cleared Dec 23, 2009
RADIONUCLIDE BRACHYTHERAPY SOURCE
K093663 · KXK
C.R. Bard, Inc.
Radiology · 28d
Cleared Dec 23, 2009
INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076
K093675 · MAX
Vertebral Technologies, Inc.
Orthopedic · 26d
Cleared Dec 23, 2009
AVS PL PEEK SPACERS
K093704 · MAX
Stryker Corp.
Orthopedic · 22d
Cleared Dec 23, 2009
STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL...
K093720 · LIT
Boston Scientific Corp
Cardiovascular · 21d
Cleared Dec 22, 2009
STRAUMANN MODIFIED DENTAL ABUTMENT
K091701 · NHA
Institut Straumann AG
Dental · 195d
Cleared Dec 22, 2009
DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE
K091762 · GXY
Covidien
Neurology · 189d
Cleared Dec 22, 2009
CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM
K091926 · KWQ
Choicespine, LP
Orthopedic · 175d
Cleared Dec 22, 2009
STA LIATEST FREE PS
K092170 · GGP
Diagnostica Stago, Inc.
Hematology · 154d
Cleared CT Dec 22, 2009
VPAP TX
K092186 · MNS
Resmed, Ltd.
Anesthesiology · 154d
Cleared Dec 22, 2009
IBA PROTON THERAPY SYSTEM, PROTEUS 235
K092796 · LHN
Ion Beam Applications S.A.
Radiology · 102d
Cleared Dec 22, 2009
PATHWAY IVB/VBR
K092904 · ODP
Custom Spine, Inc.
Orthopedic · 92d
Cleared Dec 22, 2009
ENAMELITE ACRYSEAL SPRAY SEALANT
K093019 · EBD
Enamelite, LLC
Dental · 84d
Cleared Dec 22, 2009
BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODES
K093025 · GEI
Bovie Medical Corporation
General & Plastic Surgery · 84d
Cleared Dec 22, 2009
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
K093167 · JPA
Diagnostica Stago, Inc.
Hematology · 76d
Cleared Dec 22, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K093439 · LYZ
Tangshan Pufa Plastic Products Co., Ltd.
General Hospital · 48d
Cleared Dec 22, 2009
ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT,...
K093483 · NHA
Astra Tech, Inc.
Dental · 43d
Cleared Dec 21, 2009
VERTECEM
K090435 · NDN
Teknimed, S.A.
Orthopedic · 305d
Cleared Dec 21, 2009
LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS
K091543 · MBH
Smith & Nephew, Inc.
Orthopedic · 209d
Cleared Dec 18, 2009
ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)
K090515 · KFM
Maquet Cardiopulmonary, AG
Cardiovascular · 295d
Cleared Dec 18, 2009
QUART ARTERIAL FILTER WITH SOFTLINE COATING
K090518 · DTM
Maquet Cardiopulmonary, AG
Cardiovascular · 295d
Cleared Dec 18, 2009
HLM TUBING SET WITH SOFTLINE COATING
K090533 · DWF
Maquet Cardiopulmonary, AG
Cardiovascular · 294d
Cleared Dec 18, 2009
SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS,...
K090806 · LPL
Safilens, S.R.L.
Ophthalmic · 268d
Cleared Dec 18, 2009
ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02,...
K090921 · DWL
Beiersdorf, Inc.
General Hospital · 261d