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

Filters: Cleared only ×
175,820 results
34441–34464 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 2015
Smith and Nephew Legion Hinge Knee System
K151118 · KRO
Smith & Nephew
Orthopedic · 92d
Cleared Jul 28, 2015
Elements
K151150 · ELW
Pac-Dent International, Inc.
Dental · 89d
Cleared Jul 28, 2015
Proton Immobilization Solution
K151207 · IYE
Orfit Industries NV
Radiology · 83d
Cleared Jul 28, 2015
Axium Detachable Coil System
K151447 · HCG
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 60d
Cleared Jul 28, 2015
Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control...
K151464 · OCC
Alere Scarborough, Inc.
Microbiology · 57d
Cleared Jul 28, 2015
3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD Display
K151854 · LLZ
D-View Display Technology Co., Ltd.
Radiology · 21d
Cleared Jul 27, 2015
EM25 - glute toning device
K143737 · NGX
Hivox Biotek, Inc.
Physical Medicine · 209d
Cleared Jul 27, 2015
Serenity
K150014 · KLW
Sanuthera, Inc.
Ear, Nose, Throat · 203d
Cleared Jul 27, 2015
Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with...
K150236 · JWY
Thermo Fisher Scientific
Microbiology · 175d
Cleared Jul 27, 2015
A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter...
K150924 · GZB
Anchor Innovation Medical (A.I.M.)
General & Plastic Surgery · 112d
Cleared Jul 27, 2015
QuadraSphere Microspheres
K151187 · KRD
Biosphere Medical, S.A.
Neurology · 84d
Cleared Jul 27, 2015
BD Angiocath IV Catheter, BD Insyte IV Catheter
K151698 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 33d
Cleared Jul 27, 2015
Barricade Embolization Coil System
K151760 · HCG
Blockade Medical
Neurology · 28d
Cleared Jul 24, 2015
TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS
K141289 · JIL
Teco Diagnostics
Chemistry · 431d
Cleared Jul 24, 2015
ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST
K141427 · JOZ
Accumetrics, Inc.
Hematology · 420d
Cleared Jul 24, 2015
RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE...
K142129 · DIO
Biophor Diagnostics, Inc.
Toxicology · 354d
Cleared Jul 24, 2015
O Glide Personal Lubricant
K142726 · NUC
Grafenberg Labs
Obstetrics & Gynecology · 304d
Cleared Jul 24, 2015
Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set
K142819 · DYB
Cook Incorporated
Cardiovascular · 298d
Cleared Jul 24, 2015
IV Administration Sets with 200(micro)m Blood Filter
K143082 · FPA
B.Braun Medical, Inc.
General Hospital · 270d
Cleared Jul 24, 2015
Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions
K143102 · NIE
Arrow International, Inc. (Subsidiary...
Gastroenterology & Urology · 268d
Cleared CT Jul 24, 2015
OrthoPulse
K143120 · PLH
Biolux Research , Ltd.
Dental · 267d
Cleared Jul 24, 2015
Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters
K143193 · LIT
Boston Scientific
Cardiovascular · 260d
Cleared Jul 24, 2015
Powder-Free Yellow Vinyl Patient Examination Gloves
K143347 · LYZ
Zibo Zhouheng Plastic Products Co., Ltd.
General Hospital · 245d
Cleared Jul 24, 2015
LOCATOR RTx
K150295 · NHA
Zest Anchors, Inc.
Dental · 168d