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
77257–77280 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 06, 2002
CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS
K012616 · JOW
Clearmedical, Inc.
Cardiovascular · 177d
Cleared Feb 06, 2002
CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENT
K012621 · JOW
Clearmedical, Inc.
Cardiovascular · 177d
Cleared Feb 06, 2002
OVUS CAPLESS SAFETY NEEDLE
K013006 · MEG
Ovus Systems
General Hospital · 153d
Cleared Feb 06, 2002
BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY
K013717 · DPS
Brentwood Medical Technology Corp.
Cardiovascular · 90d
Cleared Feb 06, 2002
MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER
K013723 · ITX
Hitachi Medical Corp.
Radiology · 89d
Cleared Feb 06, 2002
ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND ACCESSORIES
K013730 · GEI
Novasys Medical, Inc.
General & Plastic Surgery · 89d
Cleared Feb 06, 2002
HANDHELD GAMMA FINDER (HGF)
K013751 · IZD
Silicon Instruments Gmhb
Radiology · 85d
Cleared Feb 06, 2002
RIDIDFIX 2.7MM BTB CROSS PIN KIT
K013781 · HTY
Mitek Products
Orthopedic · 84d
Cleared Feb 06, 2002
MARK 5000 QUADRATURE SHOULDER COIL
K013854 · MOS
Usa Instruments, Inc.
Radiology · 78d
Cleared Feb 06, 2002
POWDERFREE LATEX SURGEON'S GLOVES
K013914 · KGO
Kanam Latex Industries Pvt. , Ltd.
General Hospital · 71d
Cleared Feb 06, 2002
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
K014169 · FIP
Bob J. Johnson & Assoc., Inc.
Gastroenterology & Urology · 49d
Cleared Feb 06, 2002
AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM
K014187 · CAC
Boehringer Laboratories
Anesthesiology · 47d
Cleared Feb 06, 2002
MODIFICATION TO GEO STRUCTURE
K020048 · MQP
Interpore Cross Intl.
Orthopedic · 30d
Cleared Feb 06, 2002
FUKUDA DENSHI DYNASCOPE MODEL DS-5700
K020084 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 27d
Cleared Feb 06, 2002
SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
K020109 · GGC
Sigma Diagnostics, Inc.
Hematology · 26d
Cleared Feb 06, 2002
MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN...
K020168 · LON
Dade Behring, Inc.
Microbiology · 20d
Cleared Feb 06, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE...
K020173 · LON
Dade Behring, Inc.
Microbiology · 20d
Cleared Feb 06, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NETILMICIN...
K020182 · LON
Dade Behring, Inc.
Microbiology · 19d
Cleared Feb 06, 2002
MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTAMICIN...
K020185 · LON
Dade Behring, Inc.
Microbiology · 19d
Cleared Feb 06, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMIKACIN...
K020209 · LON
Dade Behring, Inc.
Microbiology · 15d
Cleared Feb 06, 2002
R & D BODY FLUID CONTROL
K020229 · JPK
R&D Systems, Inc.
Hematology · 14d
Cleared Feb 06, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25,...
K020246 · LON
Dade Behring, Inc.
Microbiology · 13d
Cleared Feb 06, 2002
MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML)
K020249 · LON
Dade Behring, Inc.
Microbiology · 13d
Cleared Feb 06, 2002
LOGIQ 3
K020263 · IYN
General Electric Co.
Radiology · 12d