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
46729–46752 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 2011
SMR REVERSE SHOULDER SYSTEM
K110598 · PHX
Lima Corporate S.P.A.
Orthopedic · 169d
Cleared Aug 18, 2011
IMC BLOOD COLLECTION NEEDLE
K110656 · FMI
International Medsurg Connection
General Hospital · 164d
Cleared Aug 18, 2011
IMC INSULIN SYRINGE
K110882 · FMF
International Medsurg Connection
General Hospital · 141d
Cleared Aug 18, 2011
TRUEBEAM
K111106 · IYE
Varian Medical Systems, Inc.
Radiology · 120d
Cleared Aug 18, 2011
XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT
K111167 · IXW
Velopex International, Inc.
Radiology · 114d
Cleared Aug 18, 2011
SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND...
K111429 · JWY
Trek Diagnostic Systems, Ltd.
Microbiology · 87d
Cleared Aug 18, 2011
MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH...
K111807 · KGO
Medline Industries, Inc.
General Hospital · 52d
Cleared Aug 18, 2011
SYNGO.CT VASCULAR ANALYSIS
K112020 · JAK
Siemens Medi Cal Solutions, Inc.
Radiology · 35d
Cleared Aug 17, 2011
NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS
K100602 · KHP
Nova Biomedical Corp.
Chemistry · 532d
Cleared Aug 17, 2011
ADVIA CHEMISTRY FERRITIN (FRT) METHOD
K110736 · DBF
Siemens Healthcare Diagnostics, Inc.
Immunology · 154d
Cleared Aug 17, 2011
PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50
K111083 · HGM
Philips Medizinsysteme Boeblingen...
Obstetrics & Gynecology · 120d
Cleared Aug 17, 2011
PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES)
K111135 · KWQ
K2m, Inc.
Orthopedic · 117d
Cleared Aug 17, 2011
FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM
K111284 · LOX
Ostial Corporation
Cardiovascular · 103d
Cleared Aug 17, 2011
REVOLVE ADDITIONAL IMPLANTS
K111449 · NKB
Globus Medical, Inc.
Orthopedic · 84d
Cleared Aug 17, 2011
REVERE CROSSTOP
K111479 · NKB
Globus Medical, Inc.
Orthopedic · 82d
Cleared Aug 17, 2011
ZOLL E SERIES
K111594 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 71d
Cleared Aug 17, 2011
VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT
K111881 · OTM
Coloplast A/S
General Hospital · 47d
Cleared Aug 17, 2011
NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER
K111900 · MSD
Teleflexmedical, Inc.
Gastroenterology & Urology · 43d
Cleared Aug 17, 2011
FIBERNET EMBOLIC PROTECTION DEVICE
K111987 · NTE
Lumen Biomedical, Inc.
Cardiovascular · 35d
Cleared Aug 17, 2011
GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX,...
K112281 · DQY
Trireme Medical, Inc.
Cardiovascular · 8d
Cleared Aug 17, 2011
CROSSER RECANALIZATION SYSTEM
K112308 · PDU
C.R. Bard, Inc.
Cardiovascular · 6d
Cleared Aug 16, 2011
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND...
K101973 · LAF
Omega Laboratories, Inc.
Chemistry · 399d
Cleared Aug 16, 2011
TRUMATCH PERSONALIZED SOLUTIONS
K110397 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 186d
Cleared Aug 16, 2011
ENDO HEAD
K111145 · LZY
Medacta International
Orthopedic · 116d