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
39073–39096 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 2014
VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT
K133550 · JJX
Maine Standards Company, LLC
Chemistry · 78d
Cleared Feb 05, 2014
ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY
K133601 · CEW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 72d
Cleared Feb 05, 2014
RT016 INSPIRATORY FILTER
K133666 · CAH
Fisher &Paykel Healthcare , Ltd.
General Hospital · 68d
Cleared Feb 05, 2014
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)
K133867 · FPA
Terumo Europe N.V.
General Hospital · 47d
Cleared Feb 05, 2014
CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER
K140015 · DYB
Cardiosolutions, Inc.
Cardiovascular · 34d
Cleared Feb 04, 2014
BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT...
K130320 · DQA
Covidien
Anesthesiology · 361d
Cleared Feb 04, 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K130582 · LYZ
Heze City Green Food Co., Ltd.
General Hospital · 336d
Cleared Feb 04, 2014
LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
K131653 · DKZ
Lin-Zhi International, Inc.
Toxicology · 244d
Cleared Feb 04, 2014
DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETER
K132140 · FLL
Duteck Industrial Co., Ltd.
General Hospital · 208d
Cleared Feb 04, 2014
GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER
K132383 · LJE
Gyrus Acmi, Inc.
Gastroenterology & Urology · 188d
Cleared Feb 04, 2014
STREAMLINE EXPRESS
K132602 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 168d
Cleared Feb 04, 2014
SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM
K132886 · HRS
Smith & Nephew, Inc.
Orthopedic · 141d
Cleared Feb 04, 2014
ZIMMER(R) PERSONA THE PERSONALIZED KEE SYSTEM 14X +30MM TAPERED STEM EXTENSION
K133737 · JWH
Zimmer, Inc.
Orthopedic · 57d
Cleared Feb 04, 2014
GFS II STANDARD, GFS II LARGE, GFS MIMI
K133757 · MBI
Parcus Medical, LLC
Orthopedic · 55d
Cleared Feb 04, 2014
4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE,...
K133794 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 53d
Cleared Feb 03, 2014
SHOOCIN INTRODUCER KIT
K123475 · DYB
Lepu Medical Technology (Beijing)...
Cardiovascular · 447d
Cleared Feb 03, 2014
ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES
K131249 · MEB
I-Flow, LLC
General Hospital · 278d
Cleared Feb 03, 2014
DEROYAL SPINE SPACER SYSTEM
K131292 · MAX
Deroyal Industries, Inc.
Orthopedic · 273d
Cleared Feb 03, 2014
MEDLINE SHARPS CONTAINER
K132767 · MMK
Medline Industries, Inc.
General Hospital · 152d
Cleared Feb 03, 2014
SARNS HIGH FLOW AORTIC ARCH CANNULA
K133151 · DWF
Terumo Cardiovascular Systems Corp.
Cardiovascular · 109d
Cleared Feb 03, 2014
JULIET LL LATERAL LUMBAR CAGE
K133557 · MAX
Spineart
Orthopedic · 76d
Cleared Jan 31, 2014
XIRALITE FLOURESCENCE IMAGING SYSTEM X4
K130003 · IZI
Mivenion GmbH
Radiology · 394d
Cleared Jan 31, 2014
MEDSOURCE IV SAFETY CATHETER
K131555 · FOZ
Medsource International, LLC
General Hospital · 247d
Cleared Jan 31, 2014
AVD RIGHT RADIAL DRAPE
K131571 · KKX
Advanced Vascular Dynamics
General Hospital · 246d