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
163081–163104 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 1981
AMERICAN AIRCARE SYSTEM
K811684 · FNM
American Hamilton
General Hospital · 17d
Cleared Jul 02, 1981
TUNGSTEN SYRINGE SHIELD
K811688 · IWR
Medi-Physics Inc. Dba Nycomed...
Radiology · 17d
Cleared Jul 02, 1981
GUAMSTAINER
K811697 · KPA
Tomtec
Microbiology · 16d
Cleared Jul 02, 1981
COLUMBIA
K811729 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 14d
Cleared Jul 02, 1981
BIOSATE
K811730 · JSK
Acumedia Manufacturers, Inc.
Microbiology · 14d
Cleared Jul 02, 1981
DEXTROSE BROTH
K811731 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 14d
Cleared Jul 02, 1981
THIOTONE PEPTONE
K811732 · JSK
Acumedia Manufacturers, Inc.
Microbiology · 14d
Cleared Jul 02, 1981
AZIDE BLOOD AGAR BASE
K811733 · JSJ
Acumedia Manufacturers, Inc.
Microbiology · 14d
Cleared Jul 02, 1981
BRUCELLA BROTH
K811734 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 14d
Cleared Jul 02, 1981
CTA MEDIUM
K811735 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 14d
Cleared Jul 02, 1981
DCLS AGAR
K811736 · JSJ
Acumedia Manufacturers, Inc.
Microbiology · 14d
Cleared Jul 02, 1981
HELENA PLASMINOGEN QUIPLATE PROCEDURE
K811777 · DDX
Helena Laboratories
Immunology · 9d
Cleared Jul 02, 1981
OECO NASAL CANNULA
K811789 · CAT
Oeco
Anesthesiology · 8d
Cleared Jul 01, 1981
MYOWIRE-ATEMPORARY CARDIAC PACING WIRE
K803086 · LDF
Craig & Craig, Inc.
Cardiovascular · 205d
Cleared Jul 01, 1981
TELESONIC & ARCON
K811031 · ESD
Telesonic, Inc.
Ear, Nose, Throat · 76d
Cleared Jul 01, 1981
LASER-CAL
K811063 · KRX
Diagnostic Technology, Inc.
Hematology · 75d
Cleared Jul 01, 1981
STERILE PACKAGING
K811092 · DTE
Telectronics, Inc.
Cardiovascular · 71d
Cleared Jul 01, 1981
TRANSCUTANEOUS ELECTRICAL NERVE
K811095 · GZJ
Acutec Corporation, Inc.
Neurology · 71d
Cleared Jul 01, 1981
RMI TRANSILLUMINATION LIGHT METER #295
K811108 · HJM
Radiation Measurements, Inc.
Radiology · 69d
Cleared Jul 01, 1981
SUPERFLOW CANNULA FOR ARTHROS. SURGERY
K811115
The Anspach Effort, Inc.
General & Plastic Surgery · 69d
Cleared Jul 01, 1981
DENVER PERITONEO-VENOUS SHUNT
K811183 · KPM
Denver Biomedicals, Inc.
Gastroenterology & Urology · 63d
Cleared Jul 01, 1981
ACMI ASPIRATOR KIT #8808
K811218 · EOQ
American Cystocope Makers, Inc.
Ear, Nose, Throat · 58d
Cleared Jul 01, 1981
UNIPOLAR SPECTRAX IMPL. PULSE GENERAT.
K811350 · DXY
Medtronic Vascular
Cardiovascular · 49d
Cleared Jul 01, 1981
HAEMONETICS 1000ML COMPONENT BAG
K811449 · KSR
Haemonetics Corp.
Hematology · 40d