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

Filters: Cleared only ×
176,076 results
163657–163680 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 1981
BALLOON CATHETER
K810689
Surgimed Corp.
General & Plastic Surgery · 137d
Cleared Jul 28, 1981
CARDIAC 1000 TM
K811094 · JAA
American Edwards Laboratories
Radiology · 98d
Cleared Jul 28, 1981
PRESOLDER FOR NON-PRECIOUS DENTAL ALLOYS
K811563 · EJS
Williams Gold Refining Co., Inc.
Dental · 54d
Cleared Jul 28, 1981
THE PLACER
K811582 · EID
Cavitron Corp.
Dental · 53d
Cleared Jul 28, 1981
KULZER TRANSLUX VISIBLE LIGHT CURING
K811668 · EBZ
Kulzer, Inc.
Dental · 43d
Cleared Jul 28, 1981
37% FORMALDEHYDE
K811794 · IGG
Richard-Allan Medical Ind., Inc.
Hematology · 34d
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