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
37129–37152 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 2014
CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25,...
K141949 · HWC
Aap Implantate AG
Orthopedic · 56d
Cleared Sep 12, 2014
BIOGRAPH TRUE PET/CT FAMILY SOFTWARE
K141971 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 53d
Cleared Sep 12, 2014
MYLABSEVEN, MYLABALPHA
K142008 · IYN
Esaote, S.P.A.
Radiology · 51d
Cleared Sep 12, 2014
MYLABGAMMA
K142077 · IYN
Esaote, S.P.A.
Radiology · 43d
Cleared Sep 12, 2014
C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES
K142134 · HTY
Conmed Corporation, Largo
Orthopedic · 39d
Cleared Sep 12, 2014
Pilot Pro Diode Laser
K142223 · GEX
CAO Group, Inc.
General & Plastic Surgery · 30d
Cleared Sep 12, 2014
Pilot Elite Diode Laser
K142225 · GEX
CAO Group, Inc.
General & Plastic Surgery · 30d
Cleared Sep 12, 2014
Pilot Ultra Diode Laser
K142226 · GEX
CAO Group, Inc.
General & Plastic Surgery · 30d
Cleared Sep 12, 2014
LARIAT sulture Delivery Device
K142241 · GAT
Sentreheart, Inc.
General & Plastic Surgery · 30d
Cleared Sep 11, 2014
MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE...
K134019 · FIE
Nxstage Medical, Inc.
Gastroenterology & Urology · 255d
Cleared Sep 11, 2014
CRANE ACRYLIC HERBST APPLIANCE
K140429 · LRK
Crane Dental Laboratory, Inc.
Dental · 204d
Cleared Sep 11, 2014
TABLO CARTRIDGE
K140841 · FJK
Home Dialysis Plus
Gastroenterology & Urology · 162d
Cleared Sep 11, 2014
RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE
K140991 · KNW
Ranfac, Corp.
Gastroenterology & Urology · 147d
Cleared Sep 11, 2014
OPTIMEDICA CATALYS PRECISION LASER SYSTEM
K141079 · OOE
Optimedica Corporation
Ophthalmic · 139d
Cleared Sep 11, 2014
ELITE + LASER SYSTEM
K141425 · GEX
Cynosure, Inc.
General & Plastic Surgery · 104d
Cleared Sep 11, 2014
IASSIST KNEE SYSTEM
K141601 · OLO
Zimmer Cas
Orthopedic · 87d
Cleared Sep 10, 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K130742 · LYZ
Dahoon Plastic Co., Ltd.
General Hospital · 540d
Cleared Sep 10, 2014
ITRAC CERVICAL TRACTION SYSTEM
K131983 · ITH
Pivotal Health Solutions
Physical Medicine · 439d
Cleared CT Sep 10, 2014
BTL-9000
K134040 · OLI
Btl Industries, Ltd.
General & Plastic Surgery · 253d
Cleared Sep 10, 2014
RENAISSANCE X SYSTEM
K140167 · OLO
Mazor Robotics , Ltd.
Orthopedic · 230d
Cleared Sep 10, 2014
SURGICAL DRAPE
K140195 · KKX
Griffith-Lucas, LLC
General Hospital · 226d
Cleared Sep 10, 2014
TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS
K140390 · MBF
Biomet Manufacturing Corp
Orthopedic · 208d
Cleared Sep 10, 2014
CONTACT LENS CASE
K140488 · LRX
Maca Plastics, Inc.
Ophthalmic · 195d
Cleared Sep 10, 2014
KEGEL SMART, KEGELSMART PEARL
K140780 · HIR
Regulatory Insight, Inc.
Gastroenterology & Urology · 166d