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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
68761–68784 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 2004
RESMED S8 PIONEER CPAP SYSTEM
K041209 · BZD
Resmed, Ltd.
Anesthesiology · 52d
Cleared Jul 01, 2004
REFUGE SOUND GENERATOR
K041302 · KLW
Micro-Ear Technology, Inc.
Ear, Nose, Throat · 48d
Cleared Jul 01, 2004
NASALCEASE
K041446 · EMX
Les Laboratorires Brothier, S.A.
Ear, Nose, Throat · 30d
Cleared Jul 01, 2004
SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION...
K041449 · KWP
Interpore Cross Intl.
Orthopedic · 30d
Cleared Jul 01, 2004
LIFEPAK 12 DEFIBRILLATOR/MONITOR
K041459 · MKJ
Medtronic Emergency Response Systems,...
Cardiovascular · 29d
Cleared Jul 01, 2004
CD HORIZON SPINAL SYSTEM
K041460 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Jul 01, 2004
TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC)
K041466 · JWH
Biomet Manufacturing Corp
Orthopedic · 29d
Cleared Jul 01, 2004
OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY...
K041494 · FET
Olympus Corporation
Gastroenterology & Urology · 27d
Cleared Jul 01, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K041556 · MQP
Medtronic Sofamor Danek
Orthopedic · 21d
Cleared Jul 01, 2004
DAVOL DELIVERY SYSTEM
K041641 · GCJ
C.R. Bard, Inc.
General & Plastic Surgery · 14d
Cleared Jul 01, 2004
MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE...
K041656 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 13d
Cleared Jul 01, 2004
ATRICURE DISSECTOR
K041681 · FTD
AtriCure, Inc.
General & Plastic Surgery · 10d
Cleared Jun 30, 2004
MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET...
K032438 · NGT
Tyco Healthcare
General Hospital · 328d
Cleared Jun 30, 2004
BMLS03-3
K033174 · IPF
Biomedical Life Systems, Inc.
Physical Medicine · 273d
Cleared Jun 30, 2004
LACTOSCREW SCREW ANCHOR
K033355 · HWC
Biomet Orthopedics, Inc.
Orthopedic · 254d
Cleared Jun 30, 2004
PORTABLE SLEEP DATA RECORDER (PSDR)
K033402 · MNR
Pro-Tech Services, Inc.
Anesthesiology · 250d
Cleared Jun 30, 2004
STRAUMANN DENTAL IMPLANT SYSTEM
K033984 · DZE
Institut Straumann AG
Dental · 190d
Cleared Jun 30, 2004
H-FLOW VALVE
K034043 · DQO
Elcam Medical Acal
Cardiovascular · 184d
Cleared Jun 30, 2004
MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH
K040364 · FTM
Porex Surgical, Inc.
General & Plastic Surgery · 138d
Cleared Jun 30, 2004
TELENABLE EMS SYSTEM
K040663 · DRG
Molex, Inc.
Cardiovascular · 110d
Cleared Jun 30, 2004
IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY...
K040674 · EFA
Anthogyr
Dental · 107d
Cleared Jun 30, 2004
WEST NILE VIRUS IGM CAPTURE ELISA
K040854 · NOP
Focus Technologies, Inc.
Microbiology · 90d
Cleared Jun 30, 2004
GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM
K040862 · BZD
Caradyne, Ltd.
Anesthesiology · 89d
Cleared Jun 30, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K041030 · MNI
Medtronic Sofamor Danek
Orthopedic · 70d