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
161425–161448 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 1982
MIC-2000 PLUS, 96 CHANNEL DISPENSER
K820821 · JTC
Dynatech Corp.
Microbiology · 21d
Cleared Apr 14, 1982
SAMM
K820828 · DXH
Dart Medical Equipment
Cardiovascular · 19d
Cleared Apr 14, 1982
PERCOR PERCUTANEOUS INTRODUCER
K820834 · DYB
Datascope Corp.
Cardiovascular · 19d
Cleared Apr 14, 1982
CURITY SHETHOSCOPE SECURING PADS
K820872 · KGX
The Kendal Co.
General & Plastic Surgery · 16d
Cleared Apr 14, 1982
DISPOSABLE SURGICAL FACE MASK
K820893 · FXX
Anago, Inc.
General Hospital · 15d
Cleared Apr 13, 1982
PERCUTANEOUS NEPHROSTOMY SET
K820867 · GBO
Van-Tec, Inc.
General & Plastic Surgery · 15d
Cleared Apr 12, 1982
CREATINE KINASE-MB KIT
K820812 · JHY
Calbiochem-Behring Corp.
Toxicology · 20d
Cleared Apr 09, 1982
CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY
K813033 · GKG
Bd Becton Dickinson Vacutainer...
Hematology · 163d
Cleared Apr 09, 1982
WATERS ILEOSTOMY VALVE
K813585 · KNT
Waters Instruments, Inc.
Gastroenterology & Urology · 102d
Cleared Apr 09, 1982
RELINER FOR HEARING AID EARMOLDS
K820185 · ESD
Aid-To-Hearing Corp.
Ear, Nose, Throat · 77d
Cleared Apr 09, 1982
TRANSTHORACIC TEMP. PACEMAKER #100TPE
K820232 · LDF
Trans Pace, Inc.
Cardiovascular · 71d
Cleared Apr 09, 1982
SAFE TDENT
K820245 · EBO
Professional Dental Studios
Dental · 70d
Cleared Apr 09, 1982
GOLD FOIL ERG ELECTRODES
K820254 · HLZ
Cadwell Laboratories, Inc.
Ophthalmic · 67d
Cleared Apr 09, 1982
PLASMA POOLER HEAT SEALER
K820301 · KSD
North American Biologicals, Inc.
Hematology · 64d
Cleared Apr 09, 1982
HEMOTEC HEPCON/SYSTEM FOUR & FOUR P
K820410 · LOX
Hemotec, Inc.
Hematology · 56d
Cleared Apr 09, 1982
E.R.C.P. CANNULAS
K820431 · ODD
American Endoscopy, Inc.
Gastroenterology & Urology · 51d
Cleared Apr 09, 1982
SYBRON BOVIE CSV HAND CONTR. ELECTROSURG
K820494 · GEI
Sybron Corp.
General & Plastic Surgery · 45d
Cleared Apr 09, 1982
BAUSCH & LOMB STERILE ALL PURPOSE SOLU
K820511 · HPX
Bausch & Lomb, Inc.
Ophthalmic · 45d
Cleared Apr 09, 1982
GELMAN GLYCO-PHORE BUFFER
K820518 · JBD
Gelman Sciences, Inc.
Chemistry · 43d
Cleared Apr 09, 1982
MUSCLE DYSFUNCTION MONITOR
K820568 · DZM
A Company, Inc.
Dental · 38d
Cleared Apr 09, 1982
ARGYLE DELEE SUCTION CATHETER W/MUCOUS
K820572 · KTR
Sherwood Medical Co.
Ear, Nose, Throat · 38d
Cleared Apr 09, 1982
ECONOMY LINE OF TRAYS
K820589 · FRG
Abco Dealers, Inc.
General Hospital · 36d
Cleared Apr 09, 1982
MICROSURGERY KNIFE
K820618 · HNN
Visitec Co.
Ophthalmic · 32d
Cleared Apr 09, 1982
ELECTROSTIMULI AVERSION MACHINE
K820622 · HCB
Michael R. Kiss
Neurology · 32d