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
41041–41064 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 13, 2013
PLATEAU SPACER SYSTEM TITANIUM
K130630 · MAX
Life Spine, Inc.
Orthopedic · 97d
Cleared Jun 13, 2013
STANDARD CONTACT LENS CASE
K130753 · LRX
Watchdog Group, LC
Ophthalmic · 86d
Cleared Jun 13, 2013
QUANTUM DENTAL IMPLANT SYSTEM
K130787 · DZE
Quantum Bioengineering, Ltd.
Dental · 84d
Cleared Jun 13, 2013
PIPELINE TOTAL HIP SYSTEM
K131237 · LPH
Pipeline Orthopedics
Orthopedic · 43d
Cleared Jun 12, 2013
VUSION CS PLUS
K122588 · ODP
Ortho Development Corp.
Orthopedic · 292d
Cleared Jun 12, 2013
AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE
K122973 · HEX
Medgyn Products, Inc.
Obstetrics & Gynecology · 259d
Cleared Jun 12, 2013
EUROIMMUN ANTI-NRNP/SM ELISA (IGG)
K123261 · LKO
Euroimmun US
Immunology · 237d
Cleared Jun 12, 2013
MINT
K130191 · NEW
Hans Biomed Corporation
General & Plastic Surgery · 138d
Cleared Jun 12, 2013
NEXUS TKO-6P LUER ACTIVATED DEVICE
K130416 · FPA
Nexus Medical, LLC
General Hospital · 113d
Cleared Jun 12, 2013
SMR 3-PEGS GLENOIDS
K130642 · KWS
Lima Corporate S.P.A.
Orthopedic · 93d
Cleared Jun 12, 2013
Z-800 INFUSION SYSTEM
K130690 · FRN
Zyno Medical, LLC
General Hospital · 90d
Cleared Jun 11, 2013
PREVENT SEAL
K122521 · EBC
Itena Clinical
Dental · 295d
Cleared Jun 11, 2013
ENGLER 25K SERIES ULTRASONIC INSERTS
K122748 · ELC
Engler Engineering Corp.
Dental · 277d
Cleared Jun 11, 2013
T3
K123292 · NIE
Medcomp
Gastroenterology & Urology · 232d
Cleared Jun 11, 2013
MAMMOMAT INSPIRATION PRIME
K123520 · MUE
Siemens Medical Solutions USA, Inc.
Radiology · 208d
Cleared Jun 11, 2013
SONENDO ENDOTHERAPY SYSTEM
K130025 · ELC
Sonendo, Inc.
Dental · 159d
Cleared Jun 11, 2013
PATHASSIST LED LIGHT FIBER
K130503 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 104d
Cleared CT Jun 11, 2013
DR LONG LENGTH IMAGING SOFTWARE
K130567 · MQB
Carestream Health, Inc.
Radiology · 99d
Cleared Jun 11, 2013
DISPOSABLE CIRCULAR STAPLER
K131303 · GDW
Changzhou City Zhiye Medical Devices...
General & Plastic Surgery · 35d
Cleared Jun 11, 2013
NON-PYROGENIC ULTRASOUND TRANSDUCER COVER
K131528 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 14d
Cleared Jun 10, 2013
DISPOSABLE 330PSI EXTENSION LINES
K120892 · DXT
Coeur, Inc.
Cardiovascular · 444d
Cleared Jun 10, 2013
STARBAND
K124023 · OAN
Orthomerica Products, Inc.
Neurology · 164d
Cleared Jun 10, 2013
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
K130907 · KTT
Stryker Trauma AG
Orthopedic · 70d
Cleared Jun 10, 2013
ACUMED TOTALW RIST FUSION PLATING SYSTEM
K131380 · HRS
Acumed, LLC
Orthopedic · 27d