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

Filters: Cleared only ×
176,076 results
64417–64440 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 07, 2005
POWER RIGHT ANGLE LINEAR CUTTER DIGITAL LOADING UNIT WITH RELOADS
K052910 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 21d
Cleared Nov 07, 2005
IGNITE BONE VOID FILLER KIT
K052913 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 21d
Cleared Nov 07, 2005
J. MORITA AZ ULTRASONIC SYSTEM
K053030 · ELC
J. Morita USA, Inc.
Dental · 11d
Cleared Nov 04, 2005
OZONE GENERATOR
K043207 · NII
Ge Infrastructure Water & Process...
General Hospital · 350d
Cleared Nov 04, 2005
LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60
K050407 · HWC
Sciences For Bio Materials
Orthopedic · 260d
Cleared Nov 04, 2005
SAFERSLEEP SYSTEM
K050883 · BSZ
Safer Sleep, LLC
Anesthesiology · 211d
Cleared Nov 04, 2005
KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT
K051061 · NWG
Kronus Market Development Associates,...
Immunology · 192d
Cleared Nov 04, 2005
STRYKER SPINE AVS ASL PEEK SPACER
K051205 · MQP
Stryker Spine
Orthopedic · 177d
Cleared Nov 04, 2005
INVOS SYSTEM
K051274 · MUD
Somanetics Corp.
Cardiovascular · 171d
Cleared Nov 04, 2005
SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS
K051312 · DSY
Veryan Medical Limited
Cardiovascular · 169d
Cleared Nov 04, 2005
TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020,...
K051583 · BZD
Tiara Medical Systems, Inc.
Anesthesiology · 142d
Cleared Nov 04, 2005
MILTEX LIGATING CLIP
K052018 · FZP
Miltex, Inc.
General & Plastic Surgery · 101d
Cleared Nov 04, 2005
NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE
K052019 · EGJ
North Coast Medical, Inc.
Physical Medicine · 101d
Cleared Nov 04, 2005
SHIAN JIA MEEI TWO CHANNEL DIGITAL T.E.N.S.
K052182 · GZJ
Shian Jia Meei Enterprise Co., Ltd.
Neurology · 86d
Cleared Nov 04, 2005
MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEM
K052456 · OMP
Blue Sky Medical Group Incorporated
General & Plastic Surgery · 58d
Cleared Nov 04, 2005
SYNTHES (USA) SPHERICAL WASHERS
K052483 · NDG
Synthes (Usa)
Orthopedic · 56d
Cleared Nov 04, 2005
PRIMECHAIR
K052496 · ITI
Dalton Medical Corp.
Physical Medicine · 53d
Cleared Nov 04, 2005
GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X
K052504 · MIB
Implantech Associates, Inc.
General & Plastic Surgery · 52d
Cleared Nov 04, 2005
CALF IMPLANT, MODEL EC17-X
K052505 · MIB
Implantech Associates, Inc.
General & Plastic Surgery · 52d
Cleared Nov 04, 2005
PIONEER U601 SERIES ASPIRATOR
K052650 · BTA
Merits Health Products Co., Ltd.
General & Plastic Surgery · 39d
Cleared Nov 04, 2005
INO THERAPEUTICS INOBLENDER, MODEL 10004
K052663 · MRO
Ino Therapeutics
Anesthesiology · 38d
Cleared Nov 04, 2005
MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
K052791 · DQY
Invatec Innovative Technologies, S.R.L.
Cardiovascular · 32d
Cleared Nov 04, 2005
CRYPTOSPORIDIUM II
K052932 · MHJ
Techlab, Inc.
Microbiology · 16d
Cleared Nov 04, 2005
SYNGO NEURO DSA CT
K053024 · JAK
Siemens AG
Radiology · 14d