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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
76897–76920 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 2001
CLIRANS E-SERIES DIALYZER
K013550 · KDI
Terumo Medical Corp.
Gastroenterology & Urology · 27d
Cleared Nov 20, 2001
IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS),...
K013566 · CEW
Diagnostic Products Corp.
Chemistry · 25d
Cleared Nov 20, 2001
HNC-63-INT NEUROVASCULAR ARRAY COIL
K013602 · MOS
Mri Devices Corp.
Radiology · 20d
Cleared Nov 20, 2001
EFILM VIDEO
K013631 · LMA
Efilm Medical, Inc.
Radiology · 15d
Cleared Nov 20, 2001
DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE
K013782 · FMI
Disetronic Medical Systems
General Hospital · 6d
Cleared Nov 19, 2001
DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE
K011322 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 202d
Cleared Nov 19, 2001
STARS2000 POWER CANNULA
K012236 · QPB
Kmi Kolster Methods, Inc.
General & Plastic Surgery · 125d
Cleared Nov 19, 2001
CYNOSURE PHOTOGENICA VL
K012806 · GEX
Cynosure, Inc.
General & Plastic Surgery · 90d
Cleared Nov 19, 2001
RECORDING AND STIMULATING ELECTRODE
K012850 · GZL
Radionics, A Division of Tyco...
Neurology · 87d
Cleared Nov 19, 2001
DOCUMENTING LASER SLIT LAMP, DP 2010
K012873 · HJO
Bausch & Lomb, Inc.
Ophthalmic · 84d
Cleared Nov 19, 2001
FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735
K012929 · FAJ
Circon Video
Gastroenterology & Urology · 80d
Cleared Nov 19, 2001
SCREW VENT IMPLANT
K013227 · DZE
Sulzer Dental, Inc.
Dental · 53d
Cleared Nov 19, 2001
SF SH CATHETER, MODEL R65-945
K013437 · LKF
A & A Medical, Inc.
Obstetrics & Gynecology · 33d
Cleared Nov 19, 2001
HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948
K013491 · LKF
A & A Medical, Inc.
Obstetrics & Gynecology · 28d
Cleared Nov 16, 2001
FANELLI BILIARY STENT
K010601 · FGE
Cook, Inc.
Gastroenterology & Urology · 261d
Cleared Nov 16, 2001
RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS
K011121 · LJE
Rusch Intl.
Gastroenterology & Urology · 218d
Cleared Nov 16, 2001
BALLPEN SPINAL NEEDLE W/WO INTRODUCER
K011122 · BSP
Rusch Intl.
Anesthesiology · 218d
Cleared Nov 16, 2001
SNAZZY2
K011473 · INI
Shoprider Intl., Inc.
Physical Medicine · 186d
Cleared Nov 16, 2001
MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM
K011556 · KWQ
Aesculap, Inc.
Orthopedic · 179d
Cleared Nov 16, 2001
IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE
K011586 · GAA
Diametrics Medical, Inc.
Chemistry · 177d
Cleared Nov 16, 2001
POWERHEART CARDIAC RHYTHM MODULE
K012197 · MKJ
Cardiac Science, Inc.
Cardiovascular · 126d
Cleared Nov 16, 2001
AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE
K012585 · LAF
Ameditech, Inc.
Toxicology · 98d
Cleared Nov 16, 2001
DISCOVERY FACET SCREW FIXATION SYSTEM
K012773 · MRW
Depuyacromed
Orthopedic · 88d
Cleared Nov 16, 2001
JOSTRA ARTERIAL PERFUSION CANNULAE
K012774 · DWF
Jostra AG
Cardiovascular · 88d