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
35017–35040 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 2015
SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE
K141900 · MUJ
Eckert & Ziegler Bebig GmbH
Radiology · 310d
Cleared May 20, 2015
cobas Cdiff Test
K142422 · OZN
Roche Molecular Systems, Inc.
Microbiology · 265d
Cleared May 20, 2015
E-App
K142719 · JAQ
Gc Medtech, LLC
Radiology · 239d
Cleared May 20, 2015
BIOFOAM Bone Wedge
K142724 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 239d
Cleared May 20, 2015
Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine...
K143502 · DJG
Immunalysis Corporation
Toxicology · 161d
Cleared May 20, 2015
K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant
K143511 · NUC
Reckitt Benckiser
Obstetrics & Gynecology · 160d
Cleared May 20, 2015
Reprocessed Cordless Ultrasonic Dissection Device
K143562 · NLQ
Sterilmed, Inc.
General & Plastic Surgery · 155d
Cleared May 20, 2015
Zimmer Persona Personalized Knee System
K150090 · MBH
Zimmer, Inc.
Orthopedic · 124d
Cleared May 20, 2015
TULA Iontophoresis System with Earset
K150453 · EGJ
Acclarent, Inc.
Physical Medicine · 89d
Cleared May 20, 2015
StatStrip Xpress Glucose Hospital Meter System
K150461 · PZI
Nova Biomedical Corporation
Chemistry · 86d
Cleared May 20, 2015
Dose Calculator
K150848 · IYE
Sun Nuclear Corporation
Radiology · 50d
Cleared May 20, 2015
Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE
K151055 · MRD
Mentor Worldwide, LLC
General & Plastic Surgery · 30d
Cleared May 19, 2015
SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD...
K141351 · NBW
Biotest Medical Corp.
Chemistry · 362d
Cleared May 19, 2015
GMX Series Medical Air/Oxygen Blender
K142291 · BZR
Gentec (Shanghai) Corporation
Anesthesiology · 274d
Cleared CT May 19, 2015
RETeval Visual Electrodiagnostic Device
K142567 · GWE
Lkc Technologies, Inc.
Neurology · 249d
Cleared May 19, 2015
ELM PTA Balloon Dilatation Catheter
K143561 · LIT
O'Connell Regulatory Consultants, Inc.
Cardiovascular · 154d
Cleared May 19, 2015
U&U Bowie-Dick Test Pack
K143629 · JOJ
U&U Medical Technology Co, Ltd.
General Hospital · 148d
Cleared May 19, 2015
Lucent
K150061 · MAX
Spinal Elements, Inc.
Orthopedic · 126d
Cleared May 19, 2015
ELITECROSS Support Catheter
K150187 · PDU
Cordis Corporation, A Johnson &...
Cardiovascular · 112d
Cleared May 19, 2015
ASTRA SPINE SYSTEM
K150417 · NKB
Spinecraft, LLC
Orthopedic · 90d
Cleared May 19, 2015
MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink...
K151236 · PJT
Medtronic Minimed, Inc.
Chemistry · 8d
Cleared May 18, 2015
HEINE BETA 200, HEINE BETA 200 S, HEINE K 180
K142486 · HLJ
Heine Optotechnik GmbH & Co. KG
Ophthalmic · 256d
Cleared May 18, 2015
Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath...
K150026 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 131d
Cleared May 18, 2015
syngo.CT Dental
K150785 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 54d