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
49969–49992 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 15, 2010
OPTOS LIMITED PANORAMIC 200CAF
K100644 · MYC
Optos Plc.
Ophthalmic · 132d
Cleared Jul 15, 2010
FLAT PANEL DETECTOR, MODEL FDR D-EVO
K100762 · MQB
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 120d
Cleared Jul 15, 2010
VIVATRAK
K101109 · KMI
Wireless Medcare, LLC
General Hospital · 86d
Cleared Jul 15, 2010
DENTLIGHT ORAL EXAM LIGHT KIT
K101140 · NXV
Dentlight, Inc.
Dental · 84d
Cleared Jul 15, 2010
NEOTRACT ANCHOR SYSTEM MODEL: REF 11208
K101252 · GAT
Neotract, Inc.
General & Plastic Surgery · 72d
Cleared Jul 15, 2010
NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM
K101254 · HWC
Tecnologia Y Diseno Industrial, S.A...
Orthopedic · 72d
Cleared Jul 15, 2010
FACET SCREW SYSTEM
K101284 · MRW
Nuvasive, Inc.
Orthopedic · 69d
Cleared Jul 15, 2010
PACSMATE MMD-5201M MONITOR
K101796 · LLZ
Iei Technology Corp.
Radiology · 17d
Cleared Jul 15, 2010
VENTRALIGHT ST MESH
K101851 · FTL
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 14d
Cleared Jul 14, 2010
MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002)
K093179 · FXX
H&H Research Company
General Hospital · 279d
Cleared Jul 14, 2010
SIMPLISSE ELECTRIC BREASTFEEDING COMPANION
K093648 · HGX
Simplisse, Inc.
Obstetrics & Gynecology · 231d
Cleared Jul 14, 2010
DISPOSABLE REFLECTIVE MARKER SPHERES
K100038 · HAW
Brainlab AG
Neurology · 188d
Cleared Jul 14, 2010
AESCULAP MONOMAX ABSORBABLE SUTURE
K100876 · NWJ
Aesculap, Inc.
General & Plastic Surgery · 106d
Cleared Jul 14, 2010
OLYMPUS CF TYPE Y0023-L, Y0023I
K101053 · FDF
Olympus Medical Systems Corporation
Gastroenterology & Urology · 90d
Cleared Jul 14, 2010
ENSITE VELOCITY SYSTEM
K101328 · DQK
St Jude Medical
Cardiovascular · 64d
Cleared Jul 14, 2010
ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY
K101735 · PNO
Angioscore, Inc.
Cardiovascular · 23d
Cleared Jul 14, 2010
PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701
K101858 · MOS
Shanghai Chenguang Medical...
Radiology · 12d
Cleared Jul 13, 2010
AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING...
K093262 · NBW
Andon Medical Co., Ltd.
Chemistry · 267d
Cleared Jul 13, 2010
MODEL 300157 CPAP SYSTEM
K100121 · BZD
Aeiomed, Inc.
Anesthesiology · 179d
Cleared Jul 13, 2010
BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT
K100360 · LXB
Cochlear Americas
Ear, Nose, Throat · 151d
Cleared Jul 13, 2010
PENUMBRA CATHERER 025
K100826 · DQY
Penumbra, Inc.
Cardiovascular · 111d
Cleared Jul 13, 2010
VARIAN HIGH ENERGY LINEAR ACCELERATOR
K100890 · IYE
Varian Medical Systems
Radiology · 104d
Cleared Jul 13, 2010
VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE
K100950 · BTO
Venner Medical (Singapore) Pte, Ltd.
Anesthesiology · 98d
Cleared Jul 13, 2010
PTA-DUO PTA BALLOON CATHETER
K101047 · LIT
Hotspur Technologies
Cardiovascular · 90d