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
161569–161592 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 29, 1981
CONVERTORS STERILE DISP. LAP SPONGE II
K813296 · EFQ
American Convertors Div., American...
General & Plastic Surgery · 36d
Cleared Dec 29, 1981
DOUBLE SEAL TUBEGUAZE STERILE BANDAGE
K813308 · NAB
Scholl, Inc.
General & Plastic Surgery · 36d
Cleared Dec 29, 1981
THIGH CUFF: X-LARGE CUFF
K813323 · DXQ
Abco Dealers, Inc.
Cardiovascular · 35d
Cleared Dec 29, 1981
BODAI SWIVEL Y
K813324 · BSY
Sontek Industries, Inc.
Anesthesiology · 35d
Cleared Dec 29, 1981
P51 ANGIOPLASTY PRESSURE TRANSDUCER
K813331 · LIT
Konigsberg Instruments, Inc.
Cardiovascular · 35d
Cleared Dec 29, 1981
GERARD MEDICAL ELECTRODE TESTER
K813358 · KRC
Gerard Medical Enterprises, Inc.
Cardiovascular · 29d
Cleared Dec 29, 1981
METRONIDAZOLE 80MCG. SENSI-DISC
K813387 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 27d
Cleared Dec 29, 1981
TISSUE PROCESSING CASSETTES & ACCESS
K813430 · IDL
American Optical Corp.
Pathology · 21d
Cleared Dec 29, 1981
PNEUMO PULSSOR
K813438 · BYI
Strom Corp.
Anesthesiology · 21d
Cleared Dec 29, 1981
CEFINASE TM DISCS
K813442 · JTO
Bd Becton Dickinson Vacutainer...
Microbiology · 19d
Cleared Dec 29, 1981
NIHON KOHDEN HEART MONITORS OMP 7101-02
K813444 · DRT
Nihon Kohden America, Inc.
Cardiovascular · 20d
Cleared Dec 29, 1981
PERCUTANEOUS ENTRY NEEDLE, SELDINGER
K813461 · DRE
Ocean Medical Products, Ltd.
Cardiovascular · 18d
Cleared Dec 29, 1981
LINE POWERED LOW ENERGY DEFIBRILLATOR II
K813471 · LDD
Narco Scientific
Cardiovascular · 15d
Cleared Dec 29, 1981
LS 5800 SERIES LIQUID SCINTILLATION
K813472 · JJJ
Beckman Instruments, Inc.
Toxicology · 15d
Cleared Dec 29, 1981
OMED DISPOSABLE BULLDOG
K813499 · DXC
Omega-Med Intl., Inc.
Cardiovascular · 15d
Cleared Dec 29, 1981
TRANSCUTANEOUS ELEC. NERVE STIMULATOR
K813501 · GZJ
Empi
Neurology · 15d
Cleared Dec 29, 1981
NARCO TELECARE ISOFLO PRESSURE MONITOR
K813502 · DRS
Narco Bio-Systems
Cardiovascular · 14d
Cleared Dec 29, 1981
SAC-CEL
K813508 · KTS
Burroughs Wellcome Co.
Pathology · 14d
Cleared Dec 29, 1981
RHESUS MONKEY BLOOD IN ALSEVER'S
K813512 · LHW
Dutchland Laboratories, Inc.
Pathology · 14d
Cleared Dec 29, 1981
EDSLAB CATHETER COVER
K813514 · DQY
American Edwards Laboratories
Cardiovascular · 14d
Cleared Dec 29, 1981
MRI TOBRAMYCIN RIA KIT
K813516 · KLB
Microanalytic Research, Inc.
Microbiology · 14d
Cleared Dec 22, 1981
AGGLUTEX METHAQUALONE TEST KIT
K812987 · KXS
Hoffmann-La Roche, Inc.
Toxicology · 57d
Cleared Dec 22, 1981
SHARIA-LH RIA KIT FOR QUANTITATION HORMO
K813213 · CEP
Intl. Immunoassay Laboratories, Inc.
Chemistry · 43d
Cleared Dec 22, 1981
TROCKI BODY VENTRILATOR
K813326 · BYT
L.T.D. 3 Co.
Anesthesiology · 28d