FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
162025–162048 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 29, 1981
TEMPORARY PERVENOUS J-ATRIAL LEAD
K812781 · LDF
Cordis Corp.
Cardiovascular · 24d
Cleared Oct 29, 1981
IMPLANTABLE VENTRICULAR-INHIBITED CARDI
K812790 · DXY
Telectronics, Inc.
Cardiovascular · 24d
Cleared Oct 29, 1981
MODEL 833 ENDOCARDIAL TINED LEAD
K812815 · DTB
Pacesetter Systems
Cardiovascular · 22d
Cleared Oct 29, 1981
MODEL 841 ENDOCARDIAL TINED LEAD
K812816 · DTB
Pacesetter Systems
Cardiovascular · 22d
Cleared Oct 29, 1981
CLEAR-RITE II
K812846 · KEM
Richard-Allan Medical Ind., Inc.
Hematology · 20d
Cleared Oct 29, 1981
XYLENE
K812847 · KEM
Richard-Allan Medical Ind., Inc.
Hematology · 20d