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
173449–173472 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 1977
INTRAOCULAR LENS
K770728
Milton Roy Co. Analytical
Ophthalmic · 8d
Cleared Apr 28, 1977
PYELOSCOPE SYSTEM
K770729 · FGA
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 8d
Cleared Apr 28, 1977
CUTTER CAST 7
K770742 · ITG
Cutter Laboratories, Inc.
Physical Medicine · 6d
Cleared Apr 28, 1977
DUODENOSCOPE, MOLEL TX-6
K770754 · FOG
American Cystocope Makers, Inc.
Anesthesiology · 3d
Cleared Apr 27, 1977
IN VITRO DIAGNOSTIC TEST
K770467
Hoffmann-La Roche, Inc.
Immunology · 48d
Cleared Apr 27, 1977
IMMUNOELECTROPHORESIS PROFILE KIT
K770566 · JZS
Kallestad Laboratories, Inc.
Immunology · 34d
Cleared Apr 27, 1977
PROBE, TEMPERATURE, SYSTEM, SARNS
K770709 · DRF
3M Health Care, Sarns
Cardiovascular · 9d
Cleared Apr 27, 1977
MONITOR, PATIENT, RESP. CARBON DIOXIDE
K770713 · CCK
Cavitron Corp.
Anesthesiology · 9d
Cleared Apr 27, 1977
CATHETER, ARTERIAL EMBOLECTOMY
K770714 · DXE
Mallinckrodt Critical Care
Cardiovascular · 9d
Cleared Apr 26, 1977
PROPANE, HIGH PURITY, INSTRUMENT GRADE
K770393 · JJO
Hycel, Inc.
Chemistry · 57d
Cleared Apr 26, 1977
REAGENT, AMYLASE LIPASE
K770400 · KHM
Bd Becton Dickinson Vacutainer...
Chemistry · 55d
Cleared Apr 26, 1977
LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE
K770401 · JJI
Bd Becton Dickinson Vacutainer...
Chemistry · 55d
Cleared Apr 26, 1977
BLOOD RESERVOIR
K770546 · DTN
Delta Medical Industries
Cardiovascular · 36d
Cleared Apr 26, 1977
CATHETER,PERCUTANEOUS INTRODUC. & SHEATH
K770561 · DYB
Usci, Div. C.R. Bard, Inc.
Cardiovascular · 34d
Cleared Apr 26, 1977
ECHOENCEPHALOGRAPH, DIGITAL, 1000
K770575 · GXW
Storz Instrument Co.
Neurology · 29d
Cleared Apr 26, 1977
GENERATOR, PULSE, CARDIAC 20U
K770656 · DXY
Edwards Pacemaker Systems
Cardiovascular · 19d
Cleared Apr 26, 1977
GENERATOR, PULSE, CARDIAC 2LU
K770657 · DXY
Edwards Pacemaker Systems
Cardiovascular · 19d
Cleared Apr 26, 1977
GENERATOR, PULSE, IMPLANTABLE
K770661 · DXY
Med Telectronics , Ltd.
Cardiovascular · 19d
Cleared Apr 26, 1977
FEEDBACK EMG SYSTEM, MODEL PE-L00
K770663 · HCC
Bio-Feedback Systems, Inc.
Neurology · 19d
Cleared Apr 26, 1977
CURETTE, UTERINE, VACUUM ASPIRATING
K770674 · HHK
American Hospital Supply Corp.
Obstetrics & Gynecology · 15d
Cleared Apr 26, 1977
COMPUTER, CARDIAC OUTPUT, MODEL KM275
K770675 · DXG
Lexington Instruments
Cardiovascular · 15d
Cleared Apr 26, 1977
VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR
K770681 · KRI
Scimed Life Systems, Inc.
Cardiovascular · 15d
Cleared Apr 26, 1977
BOTTLE, BLOOD CULTURE, BI-PHASIC
K770683 · JTW
Gibco Laboratories Life Technologies,...
Microbiology · 14d
Cleared Apr 26, 1977
CROWN, ACRYLIC, CORAL BRAND, PREFORMED
K770684 · ELZ
Parker Laboratories, Inc.
Dental · 14d