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
41017–41040 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 2013
CHABNER XRT GARMENTS
K121284 · IYE
Chabner Xrt, LLC
Radiology · 410d
Cleared Jun 14, 2013
MODULAP LOOP
K121343 · KNF
Atc Technologies, Inc.
Obstetrics & Gynecology · 406d
Cleared Jun 14, 2013
BEL-GEN COLD STORAGE SOLUTION
K121618 · KDL
Waters Medical Systems, LLC
Gastroenterology & Urology · 378d
Cleared Jun 14, 2013
PROVITEMP
K122551 · EMA
Itena Clinical
Dental · 297d
Cleared Jun 14, 2013
LASER HELMET
K122950 · OAP
Theradome, Inc.
General & Plastic Surgery · 262d
Cleared Jun 14, 2013
VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406
K123127 · JJX
Maine Standards Co.
Immunology · 253d
Cleared Jun 14, 2013
PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM
K123810 · HSB
CarboFix Orthopedics , Ltd.
Orthopedic · 185d
Cleared Jun 14, 2013
AMIA AUTOMATED PD SYSTEM
K124018 · FKX
Deka Research & Development Corp.
Gastroenterology & Urology · 169d
Cleared Jun 14, 2013
FRAXEL DUAL 1550/1927 LASER SYSTEM
K130193 · GEX
Solta Medical, Inc.
General & Plastic Surgery · 140d
Cleared Jun 14, 2013
I-MAX TOUCH 3D
K130443 · OAS
Owandy
Radiology · 113d
Cleared Jun 14, 2013
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
K130542 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 105d
Cleared Jun 14, 2013
DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
K130801 · IYN
Sonoscape Company Limited
Radiology · 84d
Cleared Jun 14, 2013
INTELLIVUE PATIENT MONITOR MX400
K130849 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 80d
Cleared Jun 14, 2013
ENFLOW IV FLUID WARMER INSULATED STRAP
K130867 · LGZ
Vital Signs, Inc., A GE Healthcare...
General Hospital · 78d
Cleared Jun 14, 2013
EMORY CARDIAC TOOLBOX 3.2
K130902 · KPS
Syntermed, Inc.
Radiology · 74d
Cleared Jun 14, 2013
OMNICUT RESECTION BLADE
K130912 · HRX
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 73d
Cleared Jun 14, 2013
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
K130992 · IYE
Philips Medical Systems (Cleveland),...
Radiology · 65d
Cleared Jun 14, 2013
NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY
K130995 · GEH
Nuance Medical, LLC
General & Plastic Surgery · 65d
Cleared Jun 14, 2013
TORC BODY
K131291 · NGX
Johari Digital Healthcare , Ltd.
Physical Medicine · 39d
Cleared Jun 14, 2013
PG-800A SERIES
K131569 · DXN
Shenzhen Pango Electronic Co., Ltd.
Cardiovascular · 15d
Cleared Jun 13, 2013
ENTERAL NUTRITION WARMER
K122449 · LGZ
Acacia, Inc.
General Hospital · 304d
Cleared Jun 13, 2013
SHASER V-MINI HAIR REMOVAL SYSTEM
K130015 · ONF
Shaser, Inc.
General & Plastic Surgery · 161d
Cleared Jun 13, 2013
GUIDEWIRE, PURSUER SERIES
K130104 · DQX
Oscor, Inc.
Cardiovascular · 149d
Cleared Jun 13, 2013
ORTHOSENSOR KNEE BALANCER
K130380 · ONN
Orthosensor, Inc.
Orthopedic · 119d