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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
55177–55200 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 2008
PASSEO-35 PTA CATHETER
K082933 · DQY
Biotronik, Inc.
Cardiovascular · 33d
Cleared Oct 31, 2008
BP LIMBO XL, BPTANGO XL, BP SALSA XL
K072752 · DQK
Datadancer Medical Systems
Cardiovascular · 400d
Cleared Oct 31, 2008
IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP...
K080057 · DKZ
Novx Systems, Inc.
Chemistry · 296d
Cleared Oct 31, 2008
SCANSCOPE XT SYSTEM
K080254 · OEO
Aperio Technologies
Pathology · 274d
Cleared Oct 31, 2008
TWINGUARD WITH CAPNOGRAPH ACCESSORY
K080527 · CCK
Trawax Pty Limited
Anesthesiology · 248d
Cleared Oct 31, 2008
STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT
K080979 · KWY
Biomet Manufacturing Corp
Orthopedic · 207d
Cleared Oct 31, 2008
ARAGON ONESHOT SYSTEM
K081312 · GEI
Aragon Surgical, Inc.
General & Plastic Surgery · 175d
Cleared Oct 31, 2008
NEUROLINK IP, MODEL PK1113
K081741 · GWQ
Excel-Tech Ltd. (Xltek)
Neurology · 134d
Cleared Oct 31, 2008
NEURON DELIVERY CATHETER 070
K082290 · DQY
Penumbra, Inc.
Cardiovascular · 81d
Cleared Oct 31, 2008
G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS
K082305 · DTK
C.R. Bard, Inc.
Cardiovascular · 79d
Cleared Oct 31, 2008
MASTER3DS
K082410 · OAS
E-Woo Technology
Radiology · 71d
Cleared Oct 31, 2008
SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM
K082821 · KWQ
Spine Smith Partners L.P.
Orthopedic · 36d
Cleared Oct 31, 2008
MODFICATION TO: EXPEDIUM SPINE SYSTEM
K082942 · NKB
Depuy Spine, Inc.
Orthopedic · 29d
Cleared Oct 31, 2008
STARLIGHT
K082945 · OAN
Orthomerica Products, Inc.
Neurology · 29d
Cleared Oct 31, 2008
PB 540 VENTILATOR
K082966 · CBK
Covidien, Formerly Nellcor Puritan...
Anesthesiology · 25d
Cleared Oct 31, 2008
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT
K082981 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 25d
Cleared Oct 31, 2008
SONIXTOUCH ULTRASOUND SYSTEM
K083095 · IYN
Ultrasonix Medical Corporation
Radiology · 14d
Cleared Oct 31, 2008
MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002
K083135 · DWJ
Thermogear, Inc.
Cardiovascular · 8d
Cleared Oct 30, 2008
HYDROLYZED COLLAGEN WITH 10% CHONDROITIN SULFATE (PSGAG, POLYSULFATED...
K081724 · KGN
Applied Nutritionals
General & Plastic Surgery · 134d
Cleared Oct 30, 2008
DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR,...
K081857 · NRP
Siemens Healthcare Diagnostics, Inc.
Toxicology · 121d
Cleared Oct 30, 2008
GRADIA CORE
K082171 · EBF
GC America, Inc.
Dental · 90d
Cleared Oct 30, 2008
TEPHAFLEX ABSORBABLE SUTURE
K082178 · NWJ
Tepha, Inc.
General & Plastic Surgery · 90d
Cleared Oct 30, 2008
THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751
K082241 · KNT
Dale Medical Products, Inc.
Gastroenterology & Urology · 84d
Cleared Oct 30, 2008
APPLICATORS FOR AFTERLOADING BRACHYTHERAPY
K082530 · JAQ
Isodose Control B.V.
Radiology · 58d