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
41305–41328 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 2013
VARIANT(TM) II TURBO HBA1C KIT - 2.0
K130990 · LCP
Bio-Rad Laboratories, Inc., Clinical...
Chemistry · 29d
Cleared May 09, 2013
TEMPERATURE SENSOR CATHETER
K131020 · EZL
Degania Silicone , Ltd.
Gastroenterology & Urology · 27d
Cleared May 09, 2013
RANGE SPINAL SYSTEM
K131030 · OSH
K2m, Inc.
Orthopedic · 27d
Cleared May 09, 2013
NMI PICC MAXIMAL BARRIER NURSING KITS
K131038 · LJS
Navilyst Medical, Inc.
General Hospital · 24d
Cleared May 08, 2013
RANGE SPINAL SYSTEM, SMALL STATURE
K122877 · OSH
K2m, Inc.
Orthopedic · 231d
Cleared May 08, 2013
OLYMPIC BRAINZ MONITOR
K123079 · OMA
Excel-Tech Ltd. (Xltek)
Neurology · 219d
Cleared May 08, 2013
MEDLINE BLOOD PRESSURE TRANSDUCER
K123095 · DRS
Medline Industries, Inc.
Cardiovascular · 218d
Cleared May 08, 2013
SOL-CARE SAFETY NEEDLE
K123684 · FMI
Sol-Millennium Medical
General Hospital · 159d
Cleared May 08, 2013
VOLISTA 400
K130513 · FTD
Maquet S.A.S.
General & Plastic Surgery · 70d
Cleared May 08, 2013
RESPONSE SPINE SYSTEM
K130655 · OSH
OrthoPediatrics Corp.
Orthopedic · 57d
Cleared May 08, 2013
BEACON TISSUE MARKER
K130763 · NEU
Scion Medical Technologies, LLC
General & Plastic Surgery · 49d
Cleared May 08, 2013
GRIDLOCK PLATING SYSTEM
K130964 · HRS
Trilliant Surgical, Ltd.
Orthopedic · 30d
Cleared May 07, 2013
DILATOR TUBE SET
K120590 · PDQ
Koros USA, Inc.
Neurology · 434d
Cleared May 07, 2013
FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE
K122064 · DJG
Tianjin New Bay Bioresearch Co., Ltd.
Toxicology · 298d
Cleared May 07, 2013
PUREFLUX-H HEMODIALYZER
K122343 · KDI
Nipro Medical Corporation
Gastroenterology & Urology · 277d
Cleared May 07, 2013
HOVERROUND TEKNIQUE
K122707 · ITI
Hoveround Corp.
Physical Medicine · 245d
Cleared May 07, 2013
HOVEROUND TEKNIQUE
K122741 · ITI
Hoveround Corp.
Physical Medicine · 242d
Cleared May 07, 2013
QUANTA FLASH ENA7
K122923 · LLL
Inova Diagnostics, Inc.
Immunology · 225d
Cleared May 07, 2013
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT
K123368 · LYY
Hartalega Sdn Bhd
General Hospital · 187d
Cleared May 07, 2013
ABL90 FLEX
K123748 · CHL
Radiometer Medical Aps
Chemistry · 152d
Cleared May 07, 2013
TEPHAFLEX MELTBLOWN CONSTRUCT
K130326 · OOD
Tepha, Inc.
General & Plastic Surgery · 88d
Cleared May 07, 2013
UNITRON TINNITUS MASKER FEATURE
K130494 · KLW
Unitron Hearing
Ear, Nose, Throat · 70d
Cleared May 07, 2013
CONI
K130624 · LLZ
Globalmed
Radiology · 60d
Cleared May 07, 2013
AZURE ANTERIOR CERVICAL PLATE SYSTEM
K130825 · KWQ
Orthofix, Inc.
Orthopedic · 42d