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
170713–170736 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 1978
MODEL 1861 BLOOD PUMP
K780953 · KFM
Medtronic Vascular
Cardiovascular · 83d
Cleared Aug 31, 1978
IMMUNOCHEMISTRY SYS. MANUAL MODE
K781006 · JZW
Beckman Instruments, Inc.
Immunology · 73d
Cleared Aug 31, 1978
OXY-ON DIGITAL OXYGEN TIMER
K781039 · BXP
Chambers & Sadler Mfg.
Anesthesiology · 73d
Cleared Aug 31, 1978
OXYGEN RICH AIR SUPPLY UNIT-MODEL 390
K781074 · CAW
Xorbox
Anesthesiology · 63d
Cleared Aug 31, 1978
DENTAL SILICONE IMPRESSION MATERIAL
K781083 · ELW
Crown Delta Corp.
Dental · 63d
Cleared Aug 31, 1978
MICROCULT-GC CULTURE TEST
K781108 · JSX
Miles Laboratories, Inc.
Microbiology · 62d
Cleared Aug 31, 1978
LEAD CONVERSION KIT, MODEL 341
K781111
Edwards Pacemaker Systems
Cardiovascular · 59d
Cleared Aug 31, 1978
LIPOPROTEIN STAIN
K781122 · HZG
Electrophoresis Corp. of America
Microbiology · 59d
Cleared Aug 31, 1978
ACCESSORY TO 4-24 RECORDER
K781129 · GWQ
Oxford Medilog, Inc.
Neurology · 57d
Cleared Aug 31, 1978
ELECTROSURGICAL PENCIL SYSTEM
K781148 · GEI
Medical Plastics, Inc.
General & Plastic Surgery · 51d
Cleared Aug 31, 1978
REPROSIL
K781151 · ELW
Dentsply Intl.
Dental · 52d
Cleared Aug 31, 1978
ELECTROCARDIOGRAPHIC ECG RECORDER
K781152 · DSM
Cardio-Dynamics Laboratories, Inc.
Cardiovascular · 52d
Cleared Aug 31, 1978
GENERATOR, PULSE, PACEMAKER
K781168 · DXY
Vitatron Medical BV
Cardiovascular · 49d
Cleared Aug 31, 1978
IMAGE
K781169 · EJT
Deringer-Ney, Inc.
Dental · 49d
Cleared Aug 31, 1978
U-DRAPE, BOUNDARY
K781172 · KKX
Procter & Gamble Mfg. Co.
General Hospital · 49d
Cleared Aug 31, 1978
TEST MODULE MODEL DM-352
K781215
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 45d
Cleared Aug 31, 1978
ECON-O2
K781219
Mountain Medical Equipment, Inc.
Cardiovascular · 45d
Cleared Aug 31, 1978
GLOBULIN TEST, HUMAN THYROXINE BINDING
K781225 · CEE
Hyland Therapeutic Div., Travenol...
Chemistry · 44d
Cleared Aug 31, 1978
ENTEROTUBE II
K781236 · JSS
Hoffmann-La Roche, Inc.
Microbiology · 42d
Cleared Aug 31, 1978
KIDNEY, ARTIFICIAL, C-DAK 2.0
K781237 · DJC
Cordis Corp.
Toxicology · 42d
Cleared Aug 31, 1978
KIDNEY, ARTIFICIAL, C-DAK 1.5
K781238 · DJC
Cordis Corp.
Toxicology · 42d
Cleared Aug 31, 1978
TEMP. CROWN MSTERIAL FOR TEETH
K781244 · EBG
Den-Mat Corp.
Dental · 43d
Cleared Aug 31, 1978
THREADED PIN, SELF DRILLING
K781251 · JDW
Ace Orthopedic Manufacturing Co.
Orthopedic · 41d
Cleared Aug 31, 1978
CHLORIDE/CARBON DIOXIDE REAGENT SET
K781275 · JFS
Nobel Scientific Industries, Inc.
Toxicology · 38d