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
40633–40656 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 05, 2013
MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM
K122553 · GKR
ACON Laboratories, Inc.
Hematology · 349d
Cleared Aug 05, 2013
PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES
K122610 · BYE
Sen MU Technology Co., Ltd.
Anesthesiology · 343d
Cleared Aug 05, 2013
EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE...
K122883 · JWH
Stelkast Company
Orthopedic · 319d
Cleared CT Aug 05, 2013
SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER
K130342 · LPL
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 175d
Cleared Aug 05, 2013
SYMMETRY KERRISON DISPOSABLE TIP RONGEURS
K130541 · HAE
Symmetry Surgical
Neurology · 157d
Cleared Aug 05, 2013
PRIMATRIX DERMAL REPAIR SCAFFOLD
K131286 · KGN
Tei Biosciences, Inc.
General & Plastic Surgery · 91d
Cleared Aug 05, 2013
EPIDOSE
K131704 · IYE
Sun Nuclear Corporation
Radiology · 55d
Cleared Aug 05, 2013
JBAIDS ANTHRAX DETECTION KIT
K131930 · NHT
Biofire Diagnostics, Inc.
Microbiology · 39d
Cleared Aug 05, 2013
EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME
K132190 · MGZ
LeMaitre Vascular, Inc.
Cardiovascular · 21d
Cleared Aug 04, 2013
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0
K130748 · OLO
Smith & Nephew, Inc.
Orthopedic · 138d
Cleared Aug 02, 2013
VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE
K121370 · FHO
Vectec
Gastroenterology & Urology · 452d
Cleared Aug 02, 2013
INTELLISAVE AX700 ANESTHESIA SYSTEM
K122063 · BSZ
Philips Anesthesia Care
Anesthesiology · 385d
Cleared Aug 02, 2013
NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0
K123347 · HRS
Normed Medizin-Technik GmbH
Orthopedic · 275d
Cleared Aug 02, 2013
SOLUTIS
K130933 · HQF
Quantel Medical
Ophthalmic · 120d
Cleared Aug 02, 2013
SOFIA(R) HCG FIA
K131166 · JHI
Quidel Corp.
Chemistry · 100d
Cleared Aug 02, 2013
BD FACS SAMPLE PREP ASSISTANT III
K131301 · PER
Becton, Dickinson & CO
Immunology · 87d
Cleared Aug 02, 2013
SIDEKICK AND USHER SUPPORT CATHETERS
K131493 · DQY
C.R. Bard, Inc.
Cardiovascular · 71d
Cleared Aug 02, 2013
MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING
K131517 · FPK
Medrad, Inc. / Bayer Medical Care, Inc.
General Hospital · 66d
Cleared Aug 02, 2013
RESTORELLE M, RESTORELLE XL
K132061 · OTO
Coloplast Corp.
Obstetrics & Gynecology · 30d
Cleared Aug 01, 2013
MYOVISION 3.0 WIREFREE SYSTEM
K123399 · IKN
Precision Biometrics, Inc.
Neurology · 269d
Cleared Aug 01, 2013
CARDIO VISION MICS AORTIC CLAMPS
K123571 · DXC
Cardiomedical GmbH
Cardiovascular · 254d
Cleared Aug 01, 2013
TOGGLELOC XTENDER
K130033 · MBI
Biomet Manufacturing Corp
Orthopedic · 209d
Cleared Aug 01, 2013
ENDOGRAPH DC
K130109 · EHD
Villa Sistemi Medicali S.P.A.
Radiology · 197d
Cleared Aug 01, 2013
INTRA-LOCK OP DENTAL IMPLANT
K130140 · DZE
Intra-Lock International
Dental · 191d