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
39001–39024 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 2014
ACTIVAPATCH ET IONTOPHORESIS PATCH
K132832 · EGJ
Activatek, Inc.
Physical Medicine · 156d
Cleared Feb 13, 2014
BARRICADE EMBOLIZATION COIL SYSTEM
K140104 · HCG
Blockade Medical
Neurology · 29d
Cleared Feb 12, 2014
POWERHEART G5 AED
K122758 · MKJ
Cardiac Science Corporation
Cardiovascular · 520d
Cleared Feb 12, 2014
POWDER FREE LATEX EXAMINATION GLOVES
K123537 · LYY
Qube Medical Product Sdn Bhd
General Hospital · 453d
Cleared Feb 12, 2014
MEPITEL AG
K130040 · FRO
Molnlycke Health Care
General & Plastic Surgery · 401d
Cleared Feb 12, 2014
OWL CONTACT LENS CASES, DOG CONTACT LENS CASES
K130930 · LRX
Ningbo Lishunda Electronics Co., Ltd.
Ophthalmic · 314d
Cleared Feb 12, 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K131033 · LYZ
Decent Plastic Co., Ltd.
General Hospital · 306d
Cleared Feb 12, 2014
ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET
K131154 · LZH
Zevex, Inc.
General Hospital · 294d
Cleared Feb 12, 2014
KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEAD
K131454 · LPH
Total Joint Orthopedics, Inc.
Orthopedic · 268d
Cleared Feb 12, 2014
CONVENTUS DRS
K131552 · HRS
Conventus Orthopaedics
Orthopedic · 258d
Cleared Feb 12, 2014
GEODESICEEG SYSTEM 400 SERIES (GES 400)
K131882 · OLT
Electrical Geodesics, Inc.
Neurology · 232d
Cleared Feb 12, 2014
METRIXCARE
K132424 · KNT
The Metrix Company
Gastroenterology & Urology · 191d
Cleared Feb 12, 2014
PTFE SURGICAL SUTURE
K132464 · NBY
Omnia Spa
General & Plastic Surgery · 189d
Cleared Feb 12, 2014
EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM
K132582 · OVE
Exactech, Inc.
Orthopedic · 180d
Cleared Feb 12, 2014
HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH
K132720 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 166d
Cleared Feb 12, 2014
C-BOX PEEK CERVICAL IBF
K132991 · ODP
Innovasis, Inc.
Orthopedic · 141d
Cleared Feb 12, 2014
SHASER V-MINI 2 HAIR REMOVAL SYSTEM
K133201 · ONF
Shaser, Inc.
General & Plastic Surgery · 118d
Cleared Feb 12, 2014
LIGER MEDICAL ESU-110
K133273 · GEI
Liger Medical, LLC
General & Plastic Surgery · 111d
Cleared Feb 12, 2014
VENA PRO
K133274 · JOW
Innovamed Health, LLC
Cardiovascular · 111d
Cleared Feb 12, 2014
15 FR. TANDEMHEART ARTERIAL CANNULA
K133293 · DWF
Cardiacassist, Inc.
Cardiovascular · 110d
Cleared Feb 12, 2014
HYPERSOUND AUDIO SYSTEM (HSS)
K133352 · EPF
Hypersound Health, Inc.
Ear, Nose, Throat · 104d
Cleared Feb 12, 2014
SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION
K133476 · HJO
Carl Zeiss Meditec, AG
Ophthalmic · 92d
Cleared Feb 12, 2014
MDIXON-QUANT
K133526 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 89d
Cleared Feb 12, 2014
LOGIQ E
K133533 · IYN
Ge Healthcare
Radiology · 86d