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
42553–42576 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 2012
ORTHODONTIC CERAMIC BRACKETS
K123094 · NJM
Tomy, Inc.
Dental · 72d
Cleared Dec 13, 2012
GORE FLOW REVERSAL SYSTEM MODEL GFRS073
K123156 · NTE
W.L. Gore & Associates, Inc.
Cardiovascular · 65d
Cleared Dec 13, 2012
AMPLIVUE C. DIFFICILE ASSAY
K123355 · OZN
Quidel Corporation
Microbiology · 43d
Cleared Dec 13, 2012
AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY...
K123448 · DTL
Medtronic, Inc.
Cardiovascular · 35d
Cleared Dec 13, 2012
DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)
K123492 · MOS
Philips Medical Systems
Radiology · 30d
Cleared Dec 13, 2012
VEX-S 100W INTRAORAL X-RAY SYSTEM
K123493 · EHD
VATECH Co., Ltd.
Radiology · 34d
Cleared Dec 13, 2012
DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM
K123503 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 30d
Cleared Dec 13, 2012
PRESTO 1000 SYSTEM
K123565 · IYN
Physiosonics, Inc.
Radiology · 23d
Cleared Dec 12, 2012
CRYOTOP
K112695 · MQK
Kitazato Biopharma Co;Ltd
Obstetrics & Gynecology · 454d
Cleared Dec 12, 2012
VSP SYSTEM
K120956 · DZJ
Medical Modeling, Inc.
Dental · 257d
Cleared Dec 12, 2012
SURGICAL GOWN, SMS
K121152 · FYA
Jiangsu Guangda Medical Material,...
General Hospital · 240d
Cleared Dec 12, 2012
LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N
K121508 · PDZ
Fotona D.D.
General & Plastic Surgery · 205d
Cleared Dec 12, 2012
ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C
K121842 · LCP
Axis-Shield Diagnostics, Ltd.
Chemistry · 170d
Cleared Dec 12, 2012
HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER
K122000 · KKX
Changzhou Holymed Products Co., Ltd.
General Hospital · 156d
Cleared Dec 12, 2012
ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K122213 · LPL
Soflex Limited
Ophthalmic · 140d
Cleared Dec 12, 2012
VASU-PICC
K122423 · LJS
Medical Components, Inc.
General Hospital · 125d
Cleared Dec 12, 2012
STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE
K122555 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 112d
Cleared Dec 12, 2012
MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM
K122571 · NKB
Seaspine, Inc.
Orthopedic · 111d
Cleared Dec 12, 2012
NAVIGATOR HD URETERAL ACCESS SHEATH SET
K122649 · FED
Boston Scientific Corp
Gastroenterology & Urology · 104d
Cleared Dec 12, 2012
TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS
K122855 · DZE
Straumann USA
Dental · 85d
Cleared Dec 12, 2012
LENSX LASER SYSTEM
K123120 · OOE
Alcon Lensx, Inc.
Ophthalmic · 70d
Cleared Dec 12, 2012
MOSAIQ ONCOLOGY INFORMATION SYSTEM
K123230 · IYE
Impac Medical Systems, Inc.
Radiology · 58d
Cleared Dec 12, 2012
S4 SPINAL SYSTEM
K123352 · NKB
Aesculap Implant Systems, Inc.
Orthopedic · 42d
Cleared Dec 11, 2012
MAVRIC SL
K113394 · LNH
Ge Medical Systems, LLC
Radiology · 391d