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
75217–75240 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 2002
REFLECTION MODIFIED ACETABULAR SHELLS
K022556 · LPH
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Aug 28, 2002
VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002
K022718 · GEI
Guidant Corporation, Cardiac Surgery
General & Plastic Surgery · 13d
Cleared Aug 28, 2002
7F LAUNCHER GUIDE CATHETER
K022764 · DQY
Medtronic Vascular
Cardiovascular · 7d
Cleared Aug 28, 2002
THE AUTOTAC SYSTEM TITANIUM TACK
K022790 · DZL
BioHorizons Implant Systems, Inc.
Dental · 6d
Cleared Aug 27, 2002
3A DENTAL IMPLANT SYSTEM
K011879 · DZE
Osseco Biosource, Ltd.
Dental · 438d
Cleared Aug 27, 2002
PALMLIGHT
K020057 · EBZ
CAO Group, Inc.
Dental · 231d
Cleared Aug 27, 2002
APL IGA ELISA KIT
K021398 · MID
Louisville Apl Diagnostics, Inc.
Immunology · 117d
Cleared Aug 27, 2002
14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55
K021759 · MSD
Medcomp
Gastroenterology & Urology · 90d
Cleared Aug 27, 2002
NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120
K021760 · HAW
Orthosoft, Inc.
Neurology · 90d
Cleared Aug 27, 2002
PROTEIN S AC
K022290 · GGP
Dade Behring, Inc.
Hematology · 43d
Cleared Aug 27, 2002
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
K022491 · JJX
Cliniqa Corporation
Chemistry · 29d
Cleared Aug 27, 2002
FONIX, MODEL 7000
K022510 · ETW
Frye Electronics, Inc.
Ear, Nose, Throat · 28d
Cleared Aug 27, 2002
COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS
K022550 · JBQ
Instrumentation Laboratory CO
Hematology · 25d
Cleared Aug 27, 2002
5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM)
K022623 · KWP
Depuyacromed
Orthopedic · 20d
Cleared Aug 27, 2002
TAILWIND
K022704 · ITI
Deltaglide
Physical Medicine · 13d
Cleared Aug 26, 2002
LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2
K020529 · KFM
A-Med Systems, Inc.
Cardiovascular · 188d
Cleared Aug 26, 2002
REPHRESH VAGINAL GEL
K021737 · NUC
Columbia Laboratories, Inc.
Obstetrics & Gynecology · 90d
Cleared Aug 26, 2002
GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES...
K021777 · GEI
Gyrus Ent LLC
General & Plastic Surgery · 88d
Cleared Aug 26, 2002
BNF
K021782 · JDS
Aap Implantate AG
Orthopedic · 88d
Cleared Aug 26, 2002
TITANIUM ANKLE ARTHRODESIS NAIL
K021786 · HSB
Biomet, Inc.
Orthopedic · 88d
Cleared Aug 26, 2002
VERTE-STACK SPINAL SYSTEM
K021791 · MQP
Medtronic Sofamor Danek
Orthopedic · 87d
Cleared Aug 26, 2002
TEMPFIX EXTERNAL FIXATION SYSTEM
K021933 · KTT
DePuy Orthopaedics, Inc.
Orthopedic · 75d
Cleared Aug 26, 2002
CERANUM 87
K021947 · EJT
Lucius Metals Com.
Dental · 74d
Cleared Aug 26, 2002
ALLGRAD 45 AND 90 CELL SEPARATION MEDIA
K022330 · MQL
Intl., Inc.
Obstetrics & Gynecology · 39d