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
53953–53976 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 27, 2009
COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY
K090410 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 37d
Cleared Mar 27, 2009
TRUEBALANCE BLOOD GLUCOSE SYSTEM
K090495 · NBW
Home Diagnostics, Inc.
Chemistry · 30d
Cleared Mar 27, 2009
POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX...
K090512 · LJT
C.R. Bard, Inc.
General Hospital · 29d
Cleared Mar 27, 2009
VRAD PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM SOFTWARE
K090649 · LLZ
Virtual Radiologic Corporation
Radiology · 16d
Cleared Mar 26, 2009
EK/P. AERUGINOSA PNA FISH
K081433 · JSS
Advandx, Inc.
Microbiology · 309d
Cleared Mar 26, 2009
RELIANCE SPINAL SCREW SYSTEM
K081978 · MNI
Reliance Medical Systems, LLC
Orthopedic · 258d
Cleared Mar 26, 2009
MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227
K082227 · GKA
Sebia
Hematology · 231d
Cleared Mar 26, 2009
C. DIFF QUIK CHEK COMPLETE
K082499 · LLH
Techlab, Inc.
Microbiology · 209d
Cleared Mar 26, 2009
V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
K082662 · GAM
Surgical Devices, Tyco Healthcare...
General & Plastic Surgery · 195d
Cleared Mar 26, 2009
MORTARA STRESS ECHO BED
K082967 · DPS
Medical Positioning, Inc.
Cardiovascular · 171d
Cleared Mar 26, 2009
STRYKER SPINE REFLEX TRANSLATIONAL ANTERIOR CERVICAL PLATING SYSTEM
K083020 · KWQ
Stryker Corp.
Orthopedic · 168d
Cleared Mar 26, 2009
COALITION SPACER
K083389 · OVE
Globus Medical, Inc.
Orthopedic · 129d
Cleared Mar 26, 2009
CRITICOOL
K083662 · DWJ
Mtre Advanced Technology , Ltd.
Cardiovascular · 106d
Cleared Mar 26, 2009
HYDRORISE AND HYDROSYSTEM
K083739 · ELW
Zhermack S.P.A.
Dental · 100d
Cleared Mar 26, 2009
MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710,...
K090112 · HBB
Medtronic Powered Surgical Solutions
Neurology · 69d
Cleared Mar 26, 2009
AOS PROXIMAL HUMERAL NAIL
K090478 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 30d
Cleared Mar 26, 2009
THE BELMONT BUDDY LITE FLUID WARMER
K090508 · BSB
Belmont Instrument Corp.
Hematology · 28d
Cleared Mar 26, 2009
FORA V12 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4247
K090536 · NBW
Taidoc Technology Corporation
Chemistry · 27d
Cleared Mar 26, 2009
ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT...
K090659 · DQY
Medtronic, Inc.
Cardiovascular · 14d
Cleared Mar 25, 2009
THE MEDCOMP .010 VASCULAR GUIDEWIRES
K081775 · DQX
Medcomp
Cardiovascular · 275d
Cleared Mar 25, 2009
SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR
K081946 · HQF
Quantel Medical
Ophthalmic · 260d
Cleared Mar 25, 2009
EVERON
K082465 · BZQ
Earlysense, Ltd.
Anesthesiology · 210d
Cleared Mar 25, 2009
COMFORTLITE NASAL MASK
K082558 · BZD
Respironics, Inc.
Anesthesiology · 202d
Cleared Mar 25, 2009
KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100...
K083234 · KKX
Kimberly-Clark Corp.
General Hospital · 142d