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
65833–65856 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 27, 2005
FORMAGRAFT COLLAGEN BONE GRAFT MATRIX
K050789 · MQV
R and D Medical, LLC
Orthopedic · 60d
Cleared May 27, 2005
PEEK CAS
K050861 · MQP
Interpore Cross Intl.
Orthopedic · 52d
Cleared May 27, 2005
MAXLOCK
K050868 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 51d
Cleared May 27, 2005
NEWDEAL ANKLE NAIL
K050882 · HSB
New Deal, S.A.
Orthopedic · 50d
Cleared May 27, 2005
MERETE DUOTHREADTM BONE SCREW
K050924 · HWC
Merete Medical GmbH
Orthopedic · 44d
Cleared May 27, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.03125-2 UG/ML
K050946 · LON
Becton, Dickinson & CO
Microbiology · 42d
Cleared May 27, 2005
PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)
K051067 · MJN
LeMaitre Vascular, Inc.
Cardiovascular · 31d
Cleared May 27, 2005
ENCORE REVERSE SHOULDER PROSTHESIS
K051075 · PHX
Encore Medical, L.P.
Orthopedic · 30d
Cleared May 27, 2005
SPSMEDICAL SPORVIEW PLUS STEAM BI TEST PACK
K051173 · FRC
Spsmedical Supply Corp.
General Hospital · 21d
Cleared May 27, 2005
PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS
K051213 · NBW
Abbott Laboratories, Inc.
Chemistry · 15d
Cleared May 27, 2005
MICROPUMP MP-101
K051252 · FRN
Micrel Medical Devices S.A.
General Hospital · 11d
Cleared May 27, 2005
INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES,...
K051341 · JEY
Inion , Ltd.
Dental · 4d
Cleared May 26, 2005
PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT
K050166 · BWC
Smiths Medical
Anesthesiology · 120d
Cleared May 26, 2005
POWERHOHN AND POWERLINE CATHETERS
K050185 · LJS
C.R. Bard, Inc.
General Hospital · 119d
Cleared May 26, 2005
V.A.C. GRANUFOAM SILVER PROTECTION DRESSING
K050261 · OMP
Kinetic Concepts, Inc.
General & Plastic Surgery · 111d
Cleared May 26, 2005
ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY
K050632 · LBS
Bayer Healthcare, LLC
Chemistry · 78d
Cleared May 26, 2005
JEIL BONE FIXATION SYSTEM
K050669 · JEY
Jeil Medical Corporation
Dental · 72d
Cleared May 26, 2005
ACCENT
K050693 · MUH
Air Techniques, Inc.
Radiology · 70d
Cleared May 26, 2005
DDRCOMBI TRAUMA
K050718 · MQB
Swissray International, Inc.
Radiology · 66d
Cleared May 26, 2005
EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM
K050766 · HWE
Zimmer Trabecular
Orthopedic · 62d
Cleared May 26, 2005
B-CAD SYSTEM, VERSION 1.0
K050846 · LLZ
The Medipattern Corporation
Radiology · 52d
Cleared May 26, 2005
XPAND CORPECTOMY SPACER
K050850 · MQP
Globus Medical, Inc.
Orthopedic · 52d
Cleared May 26, 2005
CANALIZER HYDROPHILIC GUIDE WIRE
K050873 · DQX
Medical Device Technologies, Inc.
Cardiovascular · 50d
Cleared May 26, 2005
U-BALLOON DILATION CATHETER
K050875 · EZN
C.R. Bard, Inc.
Gastroenterology & Urology · 50d