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

Filters: Cleared only ×
175,820 results
36025–36048 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 18, 2015
TruWave Disposable Pressure Transducer
K142749 · DXO
Edwards Lifesciences, LLC
Cardiovascular · 116d
Cleared Jan 16, 2015
ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET
K131950 · FIE
Summit International Medical...
Gastroenterology & Urology · 568d
Cleared Jan 16, 2015
ZOLL E SERIES
K133239 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 452d
Cleared Jan 16, 2015
REVOLUTION FULLFACE MASK
K140580 · BZD
Respironics Inc. (Dba Philips...
Anesthesiology · 316d
Cleared Jan 16, 2015
EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM
K141206 · GAW
Edwards Lifesciences, LLC
General & Plastic Surgery · 252d
Cleared Jan 16, 2015
VICTUS FEMTOSECOND LASER PLATFORM
K141379 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 234d
Cleared Jan 16, 2015
VM PACS WITH VM MEDICAL WORKSTATION
K141561 · LLZ
Visual Medica
Radiology · 218d
Cleared Jan 16, 2015
COLLAGEN DURA MEMBRANE
K141608 · GXQ
Collagen Matrix, Inc.
Neurology · 214d
Cleared Jan 16, 2015
PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0...
K141789 · FRN
Hospira, Inc.
General Hospital · 198d
Cleared Jan 16, 2015
HIVOX SPOPAD EMS
K141921 · NGX
Hivox Biotek, Inc.
Physical Medicine · 184d
Cleared Jan 16, 2015
Pulse oximeter NBM-200
K142209 · DQA
Orsense, Ltd.
Anesthesiology · 158d
Cleared Jan 16, 2015
MCS Bone Graft
K142276 · MQV
Biostructures, LLC
Orthopedic · 154d
Cleared Jan 16, 2015
Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White...
K142283 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 154d
Cleared CT Jan 16, 2015
LaborView LV1000
K142583 · OSP
Obmedical Company
Obstetrics & Gynecology · 123d
Cleared Jan 16, 2015
iMAR
K142584 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 123d
Cleared Jan 16, 2015
All Safe Huber Safety Infusion Set
K142590 · FPA
Nexus Medical, LLC
General Hospital · 123d
Cleared Jan 16, 2015
PRECISE Trauma Nail System
K142599 · HSB
Ellipse Technologies, Incorporated
Orthopedic · 123d
Cleared Jan 16, 2015
POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).
K142862 · LZA
Careplus (M) Sdn Bhd
General Hospital · 107d
Cleared Jan 16, 2015
P200DTx
K142897 · MYC
Optos Plc.
Ophthalmic · 105d
Cleared Jan 16, 2015
SpyGlass DS Direct Visualization System
K142922 · FBN
Boston Scientific Corporation
Gastroenterology & Urology · 100d
Cleared Jan 16, 2015
Proficient (TM) Facet Screw Spine System
K142980 · MRW
Spine Wave, Inc.
Orthopedic · 93d
Cleared Jan 16, 2015
GUARDIAN-SG Inflatable Bone Expander System
K143006 · NDN
Bm Korea Co., Ltd.
Orthopedic · 88d
Cleared Jan 16, 2015
Nitinol Compression Plating System
K143023 · HRS
Biomedical Enterprises, Inc.
Orthopedic · 87d
Cleared Jan 16, 2015
CrossRoads Screw System
K143039 · HWC
Orthodiscovery Group, LLC (D.B.A....
Orthopedic · 86d