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
38089–38112 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 2014
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN...
K133953 · LYY
Hartalega Sdn Bhd
General Hospital · 156d
Cleared May 28, 2014
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN...
K133956 · LZA
Hartalega Sdn Bhd
General Hospital · 156d
Cleared May 28, 2014
FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP
K140127 · GAQ
Pontis Orthopaedics, LLC
General & Plastic Surgery · 132d
Cleared May 28, 2014
CLEARVIEWHD
K140139 · LLZ
Clearview Diagnostics, Inc.
Radiology · 126d
Cleared May 28, 2014
XGEO GU60A
K140332 · KPR
Samsung Electronics Co., Ltd.
Radiology · 107d
Cleared May 28, 2014
XGEO GC80
K140334 · KPR
Samsung Electronics Co., Ltd.
Radiology · 107d
Cleared May 28, 2014
BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE
K140509 · KRO
Biomet Manufacturing, LLC
Orthopedic · 89d
Cleared May 28, 2014
LIFEBORNE INFANT RESUSCITATOR
K140707 · BTL
International Biomedical
Anesthesiology · 69d
Cleared May 28, 2014
RAYSERT PLUS INJECTOR
K141091 · MSS
Rayner Intraocular Lenses , Ltd.
Ophthalmic · 30d
Cleared May 27, 2014
ACESSA GUIDANCE SYSTEM
K132744 · HFG
Halt Medical, Inc.
Obstetrics & Gynecology · 266d
Cleared May 27, 2014
DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM
K140038 · OJP
Curexo Technology Corporation
Orthopedic · 140d
Cleared May 27, 2014
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K140423 · JWH
Conformis, Inc.
Orthopedic · 98d
Cleared May 27, 2014
SKYHAWK INTERBODY FUSION SYSTEM
K140709 · MAX
Orthofix, Inc.
Orthopedic · 67d
Cleared May 23, 2014
Best-AV2 Pro-Sport(tm)
K123099 · GZJ
Avazzia, Inc.
Neurology · 598d
Cleared May 23, 2014
MEDWS SOFTWARE (VARIANTS MEDVIEW, MEDDIAG, MEDMAMMO)
K132684 · LLZ
Medecom Sarl
Radiology · 268d
Cleared May 23, 2014
MYSPINE PEDICLE SCREW PLACEMENT GUIDES
K132788 · MNI
Medacta International
Orthopedic · 259d
Cleared May 23, 2014
NUTRA LIGHT BLUE
K132838 · OLP
Nutra Luxe MD, LLC
General & Plastic Surgery · 255d
Cleared May 23, 2014
VIBRALUNG ACOUSTICAL PERCUSSOR
K133057 · SDT
Westmed, Inc.
Anesthesiology · 238d
Cleared May 23, 2014
RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET
K133173 · JOH
Teleflexmedical, Inc.
Anesthesiology · 218d
Cleared May 23, 2014
MINNIE
K133405 · GEI
Elettronica Valseriana Srl
General & Plastic Surgery · 198d
Cleared May 23, 2014
SHERPA PAK TRANSPORTER
K133694 · KDN
Paragonix Technologies, Inc.
Gastroenterology & Urology · 171d
Cleared May 23, 2014
FMWAND HANDPIECE SE
K140384 · GEI
Domain Surgical, Inc.
General & Plastic Surgery · 98d
Cleared May 23, 2014
CORCAM HEART MONITOR
K140548 · DSI
Corcam Technologia, SA
Cardiovascular · 80d
Cleared May 23, 2014
WALLFLEX BILIARY RX STENT SYSTEM
K140630 · FGE
Boston Scientific
Gastroenterology & Urology · 73d