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
170737–170760 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 01, 1979
DIAGNOSTIC KIT, FERRITAB-FE-59
K782159 · JJA
Leeco Diagnostics, Inc.
Chemistry · 41d
Cleared Feb 01, 1979
PREGNANCY TEST KIT, DAISY 2 IN HOME
K790002 · JHJ
Boehringer Mannheim Corp.
Chemistry · 30d
Cleared Feb 01, 1979
MANIFOLD, DISPOSABLE 3 VALVE
K790010 · FMG
Cordis Corp.
General Hospital · 30d
Cleared Feb 01, 1979
SERUM, POTASSIUM DETERMINATION OF
K790018 · CEM
Fisher Scientific Co., LLC
Chemistry · 29d
Cleared Feb 01, 1979
DISPOSABLE VACUUM CURETTE
K790032 · HCY
British Marketing Ent., Ltd.
Obstetrics & Gynecology · 29d
Cleared Feb 01, 1979
INTRODUCERS
K790034 · DYB
Clincal Instruments Corp.
Cardiovascular · 29d
Cleared Feb 01, 1979
INOCULATOR, MIC-2000 DISPOSABLE
K790076 · JTC
Dynatech Laboratories, Inc.
Microbiology · 20d
Cleared Feb 01, 1979
NEEDLE, BLOOD COLLECTING
K790079 · GAA
Jelco Laboratories
General & Plastic Surgery · 23d
Cleared Feb 01, 1979
LUBRICANT, OTRHO PERSONAL
K790087 · KMJ
Ortho Pharmaceutical Corp.
General Hospital · 15d
Cleared Feb 01, 1979
CATHETER TUBING MODIFICATION
K790107 · DQO
Jelco Laboratories
Cardiovascular · 16d
Cleared Feb 01, 1979
SCALE, DIGITAL CHAIR
K790130 · FRI
Acme Medical Scale Co.
General Hospital · 9d
Cleared Feb 01, 1979
CUFF CONNECTOR
K790148 · BZA
Airlife, Inc.
Anesthesiology · 20d
Cleared Feb 01, 1979
MASK INTULATION ADAPTOR
K790149 · BZA
Airlife, Inc.
Anesthesiology · 20d
Cleared Feb 01, 1979
BIRD DRIVE LINE ADAPTOR
K790150 · BYX
Airlife, Inc.
Anesthesiology · 20d
Cleared Feb 01, 1979
VENTILATOR ELBOW W/SUCTION PORT
K790155 · BZA
Airlife, Inc.
Anesthesiology · 20d
Cleared Feb 01, 1979
TRACH T ADAPTER
K790157 · BZA
Airlife, Inc.
Anesthesiology · 20d
Cleared Jan 31, 1979
MONITOR, BECKMAN LB-3CO2
K782138 · CCK
Beckman Instruments, Inc.
Anesthesiology · 35d
Cleared Jan 31, 1979
SPIROMETER, MINI POSITIVE
K782145 · BZK
Boehringer Laboratories
Anesthesiology · 35d
Cleared Jan 30, 1979
PULSE GENERATOR, CYBERLITH IMPLANTABLE
K790221
Intermedics, Inc.
Cardiovascular
Cleared Jan 29, 1979
CARDIAC COMPUTERS, CO-10 & CO-10R
K781805 · DXG
Waters Assoc., Inc.
Cardiovascular · 97d
Cleared Jan 26, 1979
VISION-STIMULATOR, CAM
K781313 · HPL
Clement Clarke, Inc.
Ophthalmic · 179d
Cleared Jan 26, 1979
POSITIVE PLACEMENT ANETHESIA KIT
K781469 · CAZ
Arrow Intl., Inc.
Anesthesiology · 151d
Cleared Jan 26, 1979
RIA KIT, QUANTITOPE CORTISOL
K781903 · CGR
Kallestad Laboratories, Inc.
Chemistry · 74d
Cleared Jan 26, 1979
GENTAMICIN FLUROIMMUNASSAY KIT
K782025 · LCQ
Technia Diagnostics , Ltd.
Toxicology · 52d