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
162865–162888 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 02, 1981
CLEANING SOLUTION FOR RADIOMETER OSM2
K812623 · CHL
Fisher Scientific Co., LLC
Chemistry · 48d
Cleared Nov 02, 1981
STERILE DISSECTOR SPONGES-X-RAY DETECT
K812707 · GDY
Medspec Corp.
General & Plastic Surgery · 39d
Cleared Nov 02, 1981
STERILE LAPAROTOMY SPONGES-X-RAY DETECT
K812710 · GDY
Medspec Corp.
General & Plastic Surgery · 39d
Cleared Nov 02, 1981
STERILE GAUZE PADS 12PLY
K812711 · NAB
Medspec Corp.
General & Plastic Surgery · 39d
Cleared Nov 02, 1981
SHILEY ARTERIAL FILTER W/40 MICRON SCREE
K812742 · DTM
Shiley, Inc.
Cardiovascular · 34d
Cleared Nov 02, 1981
WARMING LISTHTS #96H & 96HT
K812745 · FMT
J. H. Emerson Co.
General Hospital · 34d
Cleared Nov 02, 1981
SORENSON THERMODILUTION CARDIAC COMPUT
K812757 · DXG
Sorensen Research
Cardiovascular · 33d
Cleared Nov 02, 1981
FLOW-DIRECTED BALLOON THERMODILUTION
K812761 · KRG
Nova Medical Specialties
Cardiovascular · 32d
Cleared Nov 02, 1981
SET FOR ASEPTIC DECANTING OF A FLEX I.V
K812852 · KPE
Dip, Inc.
General Hospital · 20d
Cleared Nov 02, 1981
STERI-VAC #400C GAS STERILIZER
K812867 · FLF
3M Company
General Hospital · 20d
Cleared Nov 02, 1981
PEDIATRIC MICROAGGREGATE BLOOD FILTER
K812874 · CAK
Abbott Laboratories
General Hospital · 19d
Cleared Nov 02, 1981
THE NEW 1600 ELECTRODE
K812878 · DRX
Andover Medical, Inc.
Cardiovascular · 19d
Cleared Nov 02, 1981
TELECARE ISOTEC PRESSURE TRANSDUCER DOME
K812883 · DRS
Narco Scientific
Cardiovascular · 19d
Cleared Nov 02, 1981
NARCO TELECARE PRESSURE TRANSDUCER DOME
K812884 · DRS
Narco Scientific
Cardiovascular · 19d
Cleared Nov 02, 1981
YARMO NASAL CARTILAGE SOFTENER
K812895 · KAE
American V. Mueller
Ear, Nose, Throat · 18d
Cleared Nov 02, 1981
FEMEX
K812907 · KNX
Promac
Gastroenterology & Urology · 14d
Cleared Nov 02, 1981
GILCHEM ALP REAGENT
K812912 · CJE
Gilford Diagnostics
Chemistry · 14d
Cleared Nov 02, 1981
MULTI-GRAM DEVELOPING TANK R-12 & R-3
K812919 · DKK
Marion Laboratories, Inc.
Toxicology · 14d
Cleared Nov 02, 1981
ANSWER (R)
K812924 · JHJ
Armkel, LLC
Chemistry · 14d
Cleared Nov 02, 1981
MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE
K812965 · FAM
American Optical Corp.
Gastroenterology & Urology · 11d
Cleared Oct 29, 1981
HYDROXI-FLEX IMPLANT
K812321 · DZE
Impladent
Dental · 73d
Cleared Oct 29, 1981
MODEL 325T PROGRAMMABLE PULSE GENERATOR
K812358 · DXY
Cook Pacemaker Corp.
Cardiovascular · 70d
Cleared Oct 29, 1981
SOLARIUM COMBINATION
K812663 · FTC
Tech-Pro, Inc.
General & Plastic Surgery · 41d
Cleared Oct 29, 1981
ADAPTAID #365-38
K812756 · DTD
Intermedics, Inc.
Cardiovascular · 29d