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
46921–46944 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 2011
INTEGRATED INNOVA - S5I SYSTEM OPTION
K111209 · IZI
Ge Healthcare
Radiology · 88d
Cleared Jul 26, 2011
DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM
K111388 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 70d
Cleared Jul 26, 2011
LOGIQ S8
K111582 · IYN
Ge Healthcare
Radiology · 50d
Cleared Jul 25, 2011
DIXTAL DZ-4100 SERIES PULSE OXIMETER
K103285 · DQA
Dixtal Medical, Inc.
Anesthesiology · 259d
Cleared Jul 25, 2011
3.7MM/5.0MM DYNAMIC LOCKING SCREW
K110592 · HWC
Synthes (Usa)
Orthopedic · 145d
Cleared Jul 25, 2011
GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM
K110990 · KWQ
Gold Standard Orthopedics, LLC
Orthopedic · 108d
Cleared Jul 25, 2011
VISION ONE LASER SYSTEM
K111213 · GEX
Lumenis, Inc.
General & Plastic Surgery · 84d
Cleared Jul 25, 2011
CXI TRIFORCE
K111263 · KRA
Cook Incorporated
Cardiovascular · 82d
Cleared Jul 25, 2011
CIRCUMAURAL ADHESIVE REPLACEMENT
K111555 · GWJ
R & D Medical Products, Inc.
Neurology · 52d
Cleared Jul 22, 2011
CUFF SENTRY
K102674 · BSK
Ventlab Corp.
Anesthesiology · 309d
Cleared Jul 22, 2011
VENUS CERVICAL SPINAL FIXATION SYSTEM
K103414 · MNI
L & K Biomed Co., Ltd.
Orthopedic · 242d
Cleared Jul 22, 2011
MAESTRO WRIST PLATING SYSTEM
K110271 · HRS
Biomet Manufacturing Corp
Orthopedic · 172d
Cleared Jul 22, 2011
ENDOFLIP GASTRIC TUBE
K110529 · KNT
Crospon, Ltd.
Gastroenterology & Urology · 148d
Cleared Jul 22, 2011
CERVICAL CAGE
K110915 · ODP
Eisertech, LLC
Orthopedic · 112d
Cleared Jul 22, 2011
LOGIQ E9
K110943 · IYN
Ge Healthcare
Radiology · 109d
Cleared Jul 22, 2011
SLIM E30 II CO2 LASER
K110984 · ONG
Lasering S.R.L.
General & Plastic Surgery · 106d
Cleared Jul 22, 2011
CARDIAC TRIGGER MONITOR
K110987 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 105d
Cleared Jul 22, 2011
ACRYLIC HERBST APPLIANCE
K111009 · LRK
Embassy Dental Laboratory
Dental · 102d
Cleared Jul 22, 2011
APNEA GUARD
K111110 · LRK
Advanced Brain Monitoring, Inc.
Dental · 93d
Cleared Jul 22, 2011
ROTOGRAPH EVO 3D
K111152 · MUH
Villa Sistemi Medicali S.P.A.
Radiology · 88d
Cleared Jul 22, 2011
MYLABSEVEN, MYLABALPHA
K111302 · IYN
Esaote, S.P.A.
Radiology · 74d
Cleared Jul 22, 2011
RE / STASIS (TM) GINGIVAL RETRACTION PASTE
K111348 · MVL
Centrix, Inc.
Dental · 70d
Cleared Jul 22, 2011
MP 719
K111524 · MTJ
Marine Polymer Technologies, Inc.
General & Plastic Surgery · 50d
Cleared Jul 22, 2011
GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR,...
K111631 · MBI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 39d