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
48625–48648 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 2010
AED RESECTOSCOPE
K102663 · FJL
National Advanced Endoscopy Devices,...
Gastroenterology & Urology · 106d
Cleared Dec 30, 2010
G-CINCH SUTURE GRASPER
K102931 · OCW
Usgi Medical
Gastroenterology & Urology · 87d
Cleared Dec 30, 2010
C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX...
K103122 · ILK
Aat Alber Antriebstechnik GmbH
Physical Medicine · 70d
Cleared Dec 30, 2010
VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION...
K103153 · LOX
Abbott Vascular-Cardiac Therapies
Cardiovascular · 77d
Cleared Dec 30, 2010
IRRIGATION SYSTEM
K103239 · OCX
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 58d
Cleared Dec 30, 2010
AXIOM FASCIAL CLOSURE SYSTEM
K103412 · OCW
Axiom Technology Partners, LLC
General & Plastic Surgery · 38d
Cleared Dec 30, 2010
BNX FINE NEEDLE ASPIRATION SYSTEM
K103668 · FCG
Boston Endoscopic Engineering
Gastroenterology & Urology · 14d
Cleared Dec 29, 2010
INCU I
K102279 · FMZ
Atom Medical Corporation
General Hospital · 140d
Cleared Dec 29, 2010
INFRARED EAR THERMOMETER
K103097 · FLL
Radiant Innovation, Inc.
General Hospital · 70d
Cleared Dec 29, 2010
ZENIUS SPINAL SYSTEM
K103272 · MNI
Medyssey Co, Ltd.
Orthopedic · 54d
Cleared Dec 29, 2010
SAPPHIRE ST PORTABLE DIODE LASER
K103667 · GEX
Den-Mat Holdings, LLC
General & Plastic Surgery · 14d
Cleared Dec 28, 2010
INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS
K100993 · NHA
Prismatik Dentalcraft, Inc.
Dental · 263d
Cleared Dec 28, 2010
ACL TIGHTROPE DOUBLE BUNDLE
K101837 · HTY
Arthrex, Inc.
Orthopedic · 180d
Cleared Dec 28, 2010
LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY
K102210 · DKZ
Lin-Zhi International, Inc.
Chemistry · 145d
Cleared Dec 28, 2010
MIRAGE FX
K102746 · BZD
Resmed, Ltd.
Anesthesiology · 96d
Cleared Dec 27, 2010
INCLUSIVE MINI IMPLANT
K100932 · DZE
Prismatik Dentalcraft, Inc.
Dental · 266d
Cleared Dec 27, 2010
PT2 VARIAN PROTON THERAPY SYSTEM
K101294 · LHN
Varian Medical Systems, Oncology Systems
Radiology · 231d
Cleared Dec 27, 2010
DIGITAL DIAGNOSTIC X-RAY SYSTEM
K102408 · KPR
DRGEM Corporation
Radiology · 126d
Cleared Dec 27, 2010
IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT
K102572 · KNT
Sainath Intellectual Properties, LLC
Gastroenterology & Urology · 110d
Cleared Dec 27, 2010
MEDISTIM VERIQC SYSTEM
K102595 · DPW
Medi-Stim Asa
Radiology · 109d
Cleared Dec 27, 2010
VITAL SIGNS MONITOR
K102835 · DQA
Edan Instruments, Inc.
Anesthesiology · 89d
Cleared Dec 27, 2010
OSTEOPHIL BETA-TCP
K102937 · MQV
Cytophil, Inc.
Orthopedic · 84d
Cleared Dec 27, 2010
DOSEVIEW 3D
K103193 · IYE
Standard Imaging, Inc.
Radiology · 59d
Cleared Dec 27, 2010
LIFEBRIDGE
K103357 · KFM
Lifebridge Medizintechnik AG
Cardiovascular · 41d