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
166729–166752 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 1980
CONTAIN X-RAY DETECTABLE LAP SPONGE
K801768 · GDY
The Buckeye Cellulose Corp.
General & Plastic Surgery · 23d
Cleared Aug 20, 1980
MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG
K801772 · JJH
Radiation Technology, Inc.
Microbiology · 23d
Cleared Aug 20, 1980
INTELECT
K801790 · IPF
Chattanooga Group, Inc.
Physical Medicine · 22d
Cleared Aug 20, 1980
SURGICAL INSTRUMENTS
K801819 · HXD
Robert I. Chien & Assoc., Inc.
General & Plastic Surgery · 20d
Cleared Aug 20, 1980
BAND-AID BRAND TRICOT MESH BANDAGES
K801823 · KGY
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 20d
Cleared Aug 20, 1980
BAND-AID BRAND FLEXIBLE FABRIC BANDAGE
K801824 · KGY
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 20d
Cleared Aug 20, 1980
MRM-2 OXYGEN CONSUMPTION MONITOR
K801852 · BZL
Waters Assoc., Inc.
Anesthesiology · 16d
Cleared Aug 20, 1980
BARRIER TOWEL DRAPE
K801863 · KKX
Surgikos, Inc.
General Hospital · 15d
Cleared Aug 20, 1980
BARRIER APERTURED DRAPE
K801864 · KKX
Surgikos, Inc.
General Hospital · 15d
Cleared Aug 20, 1980
CORDIS FLOW DIRECTED BALLOON CATHETER
K801865 · DYG
Cordis Corp.
Cardiovascular · 15d
Cleared Aug 20, 1980
DISPOSABLE MEDICATION NEBULIZER
K801867 · LCQ
Hospitax
Toxicology · 15d
Cleared Aug 20, 1980
BURR, DENTAL
K801886 · EJL
Aesculap Instruments Corp.
Dental · 23d
Cleared Aug 20, 1980
DRILL, DENTAL
K801887 · DZA
Aesculap Instruments Corp.
Dental · 23d
Cleared Aug 20, 1980
HANDPIECE, DENTAL
K801888 · DZA
Aesculap Instruments Corp.
Dental · 23d
Cleared Aug 20, 1980
MUELLER HINTON AGAR
K801901 · JTZ
Radiation Technology, Inc.
Microbiology · 12d
Cleared Aug 20, 1980
ENZYME-ASE I TUBES
K801915 · JTO
Microchemical Specialities, Co.
Microbiology · 9d
Cleared Aug 20, 1980
ORNITH-ASE TUBES
K801916 · JTO
Microchemical Specialities, Co.
Microbiology · 9d
Cleared Aug 20, 1980
LAB-TEK FTA-ABS KIT
K801928 · JWL
Miles Laboratories, Inc.
Microbiology · 8d
Cleared Aug 14, 1980
ELECTRONIC PACEMAKER WAVEFORM ANALYZER
K800696 · KRE
Instromedix, Inc.
Cardiovascular · 139d
Cleared Aug 14, 1980
MODIFIED BLOOD CELL COUNTING & LYSING
K801357 · GIF
Coulter Electronics, Inc.
Hematology · 66d
Cleared Aug 14, 1980
INTERMEDICS THIN LITH IV SERIES UNIPOLAR
K801450 · DXY
Intermedics, Inc.
Cardiovascular · 55d
Cleared Aug 14, 1980
NEUROGAR III-TRANSCUT. ELEC. NERVE STIM
K801576 · GZJ
Inter Med Industries, Inc.
Neurology · 36d
Cleared Aug 14, 1980
ADEL MEDICAL BIRTHING BED, MOD. LD-400
K801622 · KNC
Adel Medical , Ltd.
Obstetrics & Gynecology · 30d
Cleared Aug 14, 1980
RIONET HEARING AID AND/OR RION #HB-70
K801692 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 22d