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
42913–42936 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 2012
CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL...
K120930 · FRO
Medtrade Products , Ltd.
General & Plastic Surgery · 213d
Cleared Oct 26, 2012
SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS
K121201 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 190d
Cleared Oct 26, 2012
FLOW2, SWING
K121561 · ILK
Thyssenkrupp Accessibility B.V.
Physical Medicine · 150d
Cleared Oct 26, 2012
ECHONAVIGATOR RELEASE 1
K121781 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 130d
Cleared CT Oct 26, 2012
RENEW INSERT
K122003 · PBP
Renew Medical, Inc.
Gastroenterology & Urology · 109d
Cleared Oct 26, 2012
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY...
K122137 · IYE
Accuray Incorporated
Radiology · 100d
Cleared Oct 26, 2012
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
K122215 · FRN
Carticept Medical, Inc.
General Hospital · 93d
Cleared Oct 26, 2012
SKINTEMP II
K122325 · KGN
Human Biosciences, Inc.
General & Plastic Surgery · 86d
Cleared Oct 26, 2012
LIQUIDBAND FLOW CONTROL
K122446 · MPN
Advanced Medical Solutions...
General & Plastic Surgery · 77d
Cleared Oct 26, 2012
VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM
K122472 · LCP
Bio-Rad Laboratories, Inc., Clinical...
Chemistry · 73d
Cleared Oct 26, 2012
ABL90 FLEX
K122642 · CHL
Radiometer Medical Aps
Chemistry · 58d
Cleared Oct 26, 2012
COLUMBUS REVISION KNEE SYSTEM
K122985 · JWH
Aesculap Implant System, Inc.
Orthopedic · 30d
Cleared Oct 26, 2012
ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM
K123001 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Oct 26, 2012
TORQUE DEVICE
K123024 · DQX
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Oct 25, 2012
IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY...
K113020 · MID
Immco Diagnostics, Inc.
Immunology · 380d
Cleared Oct 25, 2012
OMNI 3 OXYGEN SYSTEM
K120785 · CAW
Caire, Inc.
Anesthesiology · 224d
Cleared Oct 25, 2012
ANCHOR-L LUMBAR CAGE
K120869 · OVD
Stryker Spine
Orthopedic · 217d
Cleared Oct 25, 2012
COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE)
K121594 · LYY
Tekmedic (M) Sdn Bhd
General Hospital · 147d
Cleared Oct 25, 2012
AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE
K121637 · MEG
Sunwell Biotech Co., Ltd.
General Hospital · 143d
Cleared Oct 25, 2012
INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS
K121921 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 115d
Cleared Oct 25, 2012
SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT,...
K121993 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 111d
Cleared Oct 25, 2012
ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM
K122262 · CAC
Haemonetics Corp.
Anesthesiology · 90d
Cleared Oct 25, 2012
SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED,...
K122299 · GCJ
Transenterix, Inc.
General & Plastic Surgery · 86d
Cleared Oct 25, 2012
GE 8CH FOOT ANKLE COIL
K122694 · MOS
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 51d