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
163345–163368 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 1981
PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM
K810699 · HLX
Visidyne Corp.
Ophthalmic · 85d
Cleared Jun 09, 1981
GE 900
K811103 · EHD
General Electric Co.
Radiology · 47d
Cleared Jun 09, 1981
BELMONT PODIATRY MODEL 065 X-RAY
K811142 · KPR
Belmont Equipment Corp.
Radiology · 43d
Cleared Jun 09, 1981
PANDOROS 1200A
K811149 · IZI
Siemens Corp.
Radiology · 43d
Cleared Jun 09, 1981
ARGOSTAT
K811195 · IYB
Tecnomed, Inc.
Radiology · 40d
Cleared Jun 09, 1981
ALLMEC 90/15
K811196 · KXJ
Tecnomed, Inc.
Radiology · 40d
Cleared Jun 09, 1981
SUPERIX 120
K811197 · IZF
Tecnomed, Inc.
Radiology · 40d
Cleared Jun 09, 1981
SORENSON CATALOG #IFL-120S
K811228 · CAC
Sorensen Research
Anesthesiology · 36d
Cleared Jun 09, 1981
SUR-FIT DISPOSABLE CONVEX INSERT
K811239 · EXB
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 36d
Cleared Jun 09, 1981
ECONOMY OPEN END DRAINAGE BAG
K811300 · EXB
Economy Plus
Gastroenterology & Urology · 29d
Cleared Jun 09, 1981
MYO-METRIC II
K811312 · LBB
Mycron Medical, Inc.
Neurology · 29d
Cleared Jun 09, 1981
CARDIOPLEGIA COOLING & ADMIN. SETS
K811368 · KRI
Bentley Laboratories, Inc.
Cardiovascular · 26d
Cleared Jun 09, 1981
SHILEY ARTERIAL FILTER
K811379 · DTM
Shiley, Inc.
Cardiovascular · 25d
Cleared Jun 09, 1981
ESTRIOL KIT
K811380 · CGI
Cambridge Nuclear Corp.
Chemistry · 25d
Cleared Jun 09, 1981
DOWNS CAP FLOW GENERATOR
K811393 · BZR
Vital Signs, Inc.
Anesthesiology · 22d
Cleared Jun 09, 1981
EDSLAB CLOSED INJECTATE DELIVERY SYSTEM
K811399 · KRB
American Edwards Laboratories
Cardiovascular · 21d
Cleared Jun 09, 1981
TRAVELAIRE
K811404 · CCQ
B & F Medical Products, Inc.
Anesthesiology · 22d
Cleared Jun 09, 1981
VENTRE/SEP
K811423 · CFP
Ventrex Laboratories, Inc.
Chemistry · 19d
Cleared Jun 09, 1981
ANESTHESIOLOGY DEVICE
K811430 · CAN
Vital Air Oxygen Co.
Anesthesiology · 18d
Cleared Jun 09, 1981
TECHNICON STAR SYSTEM
K811431 · JLW
Technicon Instruments Corp.
Chemistry · 18d
Cleared Jun 09, 1981
ACRATRAC R
K811438 · INW
Avratronics Corp.
Physical Medicine · 18d
Cleared Jun 09, 1981
RADIAL HEAD PROSTHESIS
K811451 · JDB
Cintor Orthopaedic Div.
Orthopedic · 18d
Cleared Jun 09, 1981
VANCE PROSTATIC ASPIRATION SET
K811454 · KNW
Vance Products, Inc.
Gastroenterology & Urology · 18d
Cleared Jun 09, 1981
EMIT-AND METHOTREXATE ASSAY
K811459 · LAO
Syva Co.
Chemistry · 14d