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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
150553–150576 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 1985
MEDTRONIC 6304, 6305,6306,6506 & 6506W. TEMP.PACIN
K844959 · DTB
Medtronic Vascular
Cardiovascular · 20d
Cleared Jan 09, 1985
ULTRASCAN DIGITAL B
K842757 · IYO
CooperVision, Inc.
Radiology · 177d
Cleared Jan 09, 1985
ABSORBENT ENDODONTIC POINT
K843017 · EKN
United Dental Mfg., Inc.
Dental · 162d
Cleared Jan 09, 1985
BIOGLASS OSSICULAR RECONSTRUCTION PROSTH
K843461 · ETA
American Biomaterials Corp.
Ear, Nose, Throat · 126d
Cleared Jan 09, 1985
HEMODIALYSATE SOLUTIONS
K843866 · KPO
Bicarbolyte Corp.
Gastroenterology & Urology · 99d
Cleared Jan 09, 1985
DOPSCAN PLUS DS1060
K843891 · IYO
Carolina Medical Electronics
Radiology · 99d
Cleared Jan 09, 1985
THERMOCOUPLE SENSORS, ACCESS. FOR ELECTRONIC THERM
K844056 · FLL
Sensortek, Inc.
General Hospital · 83d
Cleared Jan 09, 1985
RX CBG
K844122 · EJH
Jeneric Ind.
Dental · 78d
Cleared Jan 09, 1985
RX CBY
K844123 · EJH
Jeneric Ind.
Dental · 78d
Cleared Jan 09, 1985
PIT AND FISSURE SEAANTS
K844308 · EBC
Dentsply Intl.
Dental · 64d
Cleared Jan 09, 1985
TRAVENOL RECONSTITUTION DEVICE W/ADMIX CAP
K844340 · LHI
Travenol Laboratories, S.A.
General Hospital · 62d
Cleared Jan 09, 1985
RENAISSANCE BONDING AGENT
K844394 · EJT
Williams Gold Refining Co., Inc.
Dental · 57d
Cleared Jan 09, 1985
RENAISSANCE
K844395 · EJT
Williams Gold Refining Co., Inc.
Dental · 57d
Cleared Jan 09, 1985
ENDONEEDLE
K844619 · FHO
Endotherapeutics
Gastroenterology & Urology · 43d
Cleared Jan 09, 1985
MINI FLOW- DENTAL FLOSS
K844626 · JES
Mini Floss
Dental · 43d
Cleared Jan 09, 1985
SUNTAN CONNECTIONS BAHAMA SUN-BOOTH
K844870 · FTC
Suntan Connection
General & Plastic Surgery · 37d
Cleared Jan 08, 1985
LIGHT REFLECTION RHEOGRAPHY
K833561 · JOM
Instru-Med, Inc.
Cardiovascular · 454d
Cleared Jan 08, 1985
CELL-MATICS HERPES SIMPLEX VIRUS DETECT
K840366 · KIR
Difco Laboratories, Inc.
Microbiology · 347d
Cleared Jan 08, 1985
HEPARIN COATED ARTERIAL BLOOD FILTERS
K842813 · DTM
American Bentley
Cardiovascular · 174d
Cleared Jan 08, 1985
UROCYSTIN
K843382 · JLC
Mission Pharmacal Co.
Chemistry · 133d
Cleared Jan 08, 1985
PERMATHANE 865 & 867 UNIPOLAR POLYURETH
K843703 · DTD
Pacesetter Systems
Cardiovascular · 109d
Cleared Jan 08, 1985
MEDTRONIC 6957J
K843707 · DTB
Medtronic Vascular
Cardiovascular · 109d
Cleared Jan 08, 1985
SCIMED II MEMBRANE OXYGENATOR SYSTEM
K843956 · DTZ
Scimed Life Systems, Inc.
Cardiovascular · 91d
Cleared Jan 08, 1985
LYPHOCHEK PREGNANCY CONTROL SERUM HUMAN
K844125 · JJY
Bio-Rad
Chemistry · 77d