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
35977–36000 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 23, 2015
TransferMan 4m Micromanipulator
K142207 · MQJ
Eppendorf AG
Obstetrics & Gynecology · 165d
Cleared Jan 23, 2015
OsteoSeal Bone Hemostat
K142348 · MTJ
Hemostasis, LLC
General & Plastic Surgery · 154d
Cleared Jan 23, 2015
A7 Anesthesia System
K142552 · BSZ
Shenzhen Mindray Bio-Medical...
Anesthesiology · 135d
Cleared Jan 23, 2015
RIS500
K143000 · MQB
Ray Co., Ltd.
Radiology · 98d
Cleared Jan 23, 2015
Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated...
K143159 · PDQ
Spineguard S.A.
Neurology · 81d
Cleared Jan 23, 2015
Quattro Bolt Tenodesis Screw
K143392 · MBI
Cayenne Medical, Inc.
Orthopedic · 58d
Cleared Jan 23, 2015
Acumed Small Fragment Base Set
K143394 · HRS
Acumed, LLC
Orthopedic · 58d
Cleared Jan 23, 2015
omni TRAX Active Patient Tracker
K143396 · IYO
Civco Medical Instruments CO Inc Dba...
Radiology · 58d
Cleared Jan 23, 2015
Cannulated Screw System
K143460 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 50d
Cleared Jan 23, 2015
Audit MicroControls Linearity LQ Cystatin-C
K143571 · JJX
Aalto Scientific, Ltd.
Chemistry · 37d
Cleared Jan 23, 2015
IMMULITE 2000 CEA Calibration Verification Material
K143639 · JJX
Siemens Healthcare Diagnostics
Immunology · 32d
Cleared Jan 23, 2015
Visi Mobile Monitoring System
K143751 · MWI
Sotera Wireless, Inc.
Cardiovascular · 23d
Cleared Jan 22, 2015
PODIATRY X-RAY SYSTEM
K133959 · KPR
Source-Ray, Inc.
Radiology · 394d
Cleared Jan 22, 2015
DIGITAL ELECTROCARDIOGRAPH
K133985 · DPS
Shenzhen Biocare Bio-Medical...
Cardiovascular · 392d
Cleared Jan 22, 2015
EXCERA FITRITE TOTAL HIP ARTHROPLASTY SYSTEM
K140547 · LPH
Excera Orthopedics, Inc.
Orthopedic · 324d
Cleared Jan 22, 2015
EOS System
K142773 · KPR
Eos Imaging
Radiology · 119d
Cleared Jan 22, 2015
Deltex Medical KDP72 Doppler Probe
K142932 · DPT
Deltex Medical Limited
Cardiovascular · 105d
Cleared Jan 22, 2015
Sonoma Fibula Repair System
K142945 · HSB
Sonoma Orthopedic Products, Inc.
Orthopedic · 104d
Cleared Jan 22, 2015
Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White...
K143247 · LZA
Central Medicare Sdn Bhd
General Hospital · 71d
Cleared Jan 22, 2015
Mammography Color Display DP-M3010
K143718 · PGY
Canon, Inc.
Radiology · 24d
Cleared Jan 21, 2015
LEVO MAX
K140706 · ITI
Levo AG
Physical Medicine · 306d
Cleared Jan 21, 2015
DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM
K141599 · OVE
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 222d
Cleared Jan 21, 2015
ULTRASKIN HYDROPHILIC GUIDE WIRE
K141707 · DQX
Lepu Medical Technology (Beijing)...
Cardiovascular · 211d
Cleared Jan 21, 2015
NEUROLUMEN PN-1000
K142025 · ILY
Neurolumen, LLC
Physical Medicine · 180d