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
162817–162840 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 1981
10% NEUTRAL BUFFERED FORMALDEHYDE
K811795 · IFP
Richard-Allan Medical Ind., Inc.
Hematology · 34d
Cleared Jul 28, 1981
FORMAL ALCOHOL
K811796 · PPM
Richard-Allan Medical Ind., Inc.
Hematology · 34d
Cleared Jul 28, 1981
EOSIN-Y
K811797 · HYB
Richard-Allan Medical Ind., Inc.
Hematology · 34d
Cleared Jul 28, 1981
CLEAR-RITE
K811798 · KEM
Richard-Allan Medical Ind., Inc.
Hematology · 34d
Cleared Jul 28, 1981
CAL-RITE
K811801 · KDX
Richard-Allan Medical Ind., Inc.
Hematology · 34d
Cleared Jul 28, 1981
HEMATOXYLIN
K811802 · HYJ
Richard-Allan Medical Ind., Inc.
Hematology · 34d
Cleared Jul 28, 1981
BIPOLAR COAGULATING FORCEPS
K811820 · GEI
New England Surgical Instrument Corp.
General & Plastic Surgery · 29d
Cleared Jul 28, 1981
LIC TURNOVER BED
K811897 · FNL
Century Manufacturing Co.
General Hospital · 27d
Cleared Jul 28, 1981
CENTURY SAF-LIFT & SAF-KARY
K811900 · FNG
Century Manufacturing Co.
General Hospital · 27d
Cleared Jul 28, 1981
SINGLE CHANNEL NON-FADE OSCILLOSCOPE
K811911 · DXJ
Quinton, Inc.
Cardiovascular · 27d
Cleared Jul 28, 1981
MONITOR/VITAL SIGNS TRAY
K811915 · FME
American Hospital Supply Corp.
General Hospital · 27d
Cleared Jul 28, 1981
SE WON(ALUMINUM) DENTAL FLOSS HOLDER
K811926 · JES
Sewon Industry
Dental · 22d
Cleared Jul 28, 1981
LIFESOUND ESOPHAGEAL STETHOSCOPE
K811928 · BZT
Biomedical Concepts, Inc.
Anesthesiology · 22d
Cleared Jul 28, 1981
CHEMICAL AUTOCLAVE INDICATOR TAPE
K811936 · JOJ
American Hospital Supply Corp.
General Hospital · 22d
Cleared Jul 28, 1981
MACHIDA NASOPHARYNGO-LARYNGOSCOPE
K811943 · EQN
Machida America, Inc.
Ear, Nose, Throat · 21d
Cleared Jul 28, 1981
ELECTRONIC BLOOD PRESSURE TRANSDUCER MAN
K811980 · DRS
H.R. Biomedical, Ltd.
Cardiovascular · 15d
Cleared Jul 28, 1981
STAPHASE*
K811982 · JTL
Analytical Products, Inc.
Microbiology · 15d
Cleared Jul 28, 1981
ULTIPOR SQ40S BLOOD TRANSFUSION FILTER
K811985 · CAK
Pall Biomedical Products Co.
Hematology · 15d
Cleared Jul 28, 1981
EAGLE I HEARING AID
K811988 · ESD
Electone, Inc.
Ear, Nose, Throat · 15d
Cleared Jul 28, 1981
STAPH-IDENT
K811998 · JTO
Analytical Products, Inc.
Microbiology · 14d
Cleared Jul 28, 1981
GASTRIN RIA DIAGNOSTIC KIT
K812004 · CGC
Abbott Laboratories
Chemistry · 14d
Cleared Jul 28, 1981
CORDIOTOMY RESERVOIR
K812008 · DTN
Bentley Laboratories, Inc.
Cardiovascular · 11d
Cleared Jul 28, 1981
CARDIOTOMY RESERVOIR W/FILTER#BCR-3500
K812009 · DTN
Bentley Laboratories, Inc.
Cardiovascular · 11d
Cleared Jul 28, 1981
KOI LACRIMAL INTUBATION SYSTEM
K812010 · HMX
Koi, Inc.
Ophthalmic · 11d